Pharmaceutical. Korea Innovative. Company

Korea Innovative Pharmaceutical Company This brochure illustrates a project promoted by Korean pharmaceutical companies and with support from the Ko...
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Korea Innovative

Pharmaceutical Company

This brochure illustrates a project promoted by Korean pharmaceutical companies and with support from the Korean government, to enter global markets. You’ll meet Korea and the Korean pharmaceutical industry as a reliable partner for global collaboration.

Contents

03

Foreword

04

Pharmaceutical Industry in Korea

07

Government's Effort in Pharmaceutical Industry

08 51

Innovative Pharmaceutical Companies from Korea Supplement

Living a healthy life without diseases has been surfacing as one of the major concern as the population aging is taking place every nation around the globe. In this context, the pharmaceutical industry, dubbed as the next driving force after the IT industry, is raising high expectations for its industrial potential and capacity to enhance public health care. Over the last 120 years, the pharmaceutical industry of Korea has made an enormous contribution to promoting the public health care thanks to high production capacity and advanced technology. Also, it has accumulated experience and competency to advance into global markets. This is manifested by remarkable achievements, such as acquiring experience while developing 19 new drugs including global new drugs, accomplishing world’s 8th place in terms of competitiveness of the biotechnology field, and securing GMP in line with global standards. For its part, the Korean government has set vision to transform the nation's pharmaceutical industry into one of the top seven pharmaceutical powerhouses. To turn this vision into reality, the government has designated 43 innovative pharmaceutical companies through rigorous screenings. Selected based on multiple screening criteria ranging from innovative management including R&D investment in development of innovative drugs, to corporate social responsibility, and to ethical business practices, those innovative firms literally represent Korea. I expect those companies to reinvent themselves into global corporations that will take the lead in global markets and ultimately, contribute to achieving aspiration of health and longevity that people have long dreamed of. The Korean government, together with innovative pharmaceutical companies, is more than ready to reach for partners and people around the globe who need Korea’s cutting-edge technology and quality pharmaceuticals. As a part of the effort, the government published "Directory of Innovative Pharmaceutical Companies," which contains comprehensive information on business status of the 43 innovative pharmaceutical companies, R&D technology, major products, etc. I hope this directory helps bridge world markets and Korea’s representative innovative pharmaceutical companies. Finally, I would like to ask you to provide undivided attention and support for the Korean pharmaceutical industry, which will make inroads into global markets.

MINISTER OF HEALTH & WELFARE

Rim Chemin

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Potential of Pharmaceutical Industry in Korea

Aging populations and growing interest in health and welfare continue to drive up the demand for innovative drugs across the world. Globally, R&D spending in the pharmaceutical industry was higher than any other industry (pharmaceutical and bio ranked No. 1 with KRW 126 trillion, according to the data released by Department for Business, Innovation and Skills in UK), indicating that the future industrial structure is shifting from IT to pharmaceutical business. Pharmaceutical Industry in Korea In Korean wons, the value of drugs manufactured in Korea was KRW 15.6 trillion in 2010, up by 5.3 percent from a year ago. The annual average growth rate for the past five years was 7.9 percent. In addition, the size of the pharmaceutical market grew 5.2 percent year-on-year to KRW 18.9 trillion in 2010, growing at a fast rate of around 10% over the past five years. Accordingly, medicines manufactured in Korea are estimated to account for 1.7 percent of the global market (USD 837 billion, IMS Health) in 2009.

Size and Market Trends in Pharmaceutical Industry in Korea (Unit: KRW million, %) Category Production Export Import Balance of Payments Size of Market

2006

2007

2008

2009

2010

YoY CAGR Growth Rate (‘06-’10)

11,472,804 862,945 3,273,194

12,598,208 946,868 3,410,753

13,893,810 1,255,891 4,319,756

14,788,387 1,772,242 4,953,881

15,569,588 1,770,059 5,108,910

5.3 - 0.1 3.1

7.9 19.7 11.8

△2,410,249

△2,463,885

△3,063,865

△3,181,640

△3,338,850

- 4.9

- 8.5

13,883,053

15,062,093

16,957,675

17,970,027

18,908,438

5.2

8.0

Note: 1) Pharmaceutical products include finished products, narcotic drugs, ultra narcotic, psychotropic substance and drug substance 2) Numbers in export and import categories are calculated in Korean won and converted US dollar by using annual average exchange rate at Bank of Korea Source: 2011 Pharmaceutical Industry Statistics, Korea Pharmaceutical Manufacturers Association (KPMA) Facts & Survey Report, 2011, Korea Pharmaceutical Traders Association (KPTA)

Based on its technological competitiveness and quality drugs, the pharmaceutical industry in Korea has taken a stride in strengthening its ability to develop innovative drugs in a short period of time, including R&D, clinical trials and drug manufacturing. Impressive growth made in the last few years suggests that Koreabased pharmaceutical companies are ready to take a leap forward as global players.

[R&D] Development of innovative medicines and strong pipelines across various therapeutic areas The local pharmaceutical industry began to manufacture both finished products and drug substances in the 1960s, and developed new processes in the 1980s. Following the early phase of drug development in the late 1980s, Korean pharmaceutical industry began to develop innovative drugs in the 2000s, and has successfully developed some innovative and incrementally modified drugs since then. Since the introduction the chemical compound patent system in 1987, the number of innovative drugs introduced in the country has also increased at a very fast pace. Korea has seen development of innovative drugs across

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various therapeutic areas, from “Sunpla Injection,” a treatment for stomach cancer developed by SK Pharmaceuticals in 1999 to “gemigliptin tartrate,” a treatment for diabetes mellitus developed by LG Life Sciences in 2012. So far, Korean pharmaceutical companies have developed therapies in an array of areas including oncology, antibacterial, gastritis, respiratory infections, duodenal ulcer, diabetic foot ulcer, erectile dysfunction, hepatitis B and hypertension. Research and development efforts are also being made in various drug pipelines. Forty-three companies, named in 2012 as Innovative Pharmaceutical Companies, are now leading the research on various types of drugs across various therapeutic areas. According to a recent survey on R&D pipelines, as many as 671 drugs are now being developed and are in the pipelines. By type of drugs, synthetic drugs accounted for 217, incrementally modified drugs 166, bio medicines 161, natural compounds 52, DDS 27, generics 26 and others 22. By type of diseases, oncology accounted for 122, circulatory system 89, metabolic/endocrine system 86, digestive system 53 and infectious diseases 40.

Local manufacturing of finished products and drug substance

Early years of drug development

Development of new processes

Drug development getting on track

Development of innovative drugs targeting the global market 2010’s

2000’s

1990’s

1980’s

1960/70’s

Launch of innovative drugs (total of 19) ’99

’01

’02

’03

’05

’06

’07

’08

’10

2012

Sunpla Injection

EGF

Factive

Apitoxin

Revanex

Levovir

Pelubi

Noltec

Pyramax

Supect

Milican

Peudovaccin

Zydena

Kanab

Zemiglo

Q-roxin

Camtobell

Mvix

Zepeed

Drug Development in Korea

[Clinical Trials] Clinical trials grew dramatically from both qualitative and quantitative perspectives Already on a clear growth track with its high level of clinical trial capabilities and reliable data, Korea is emerging as a core clinical trial destination in the pharmaceutical market in Asia. Seoul-based 13 major healthcare organizations, including Seoul Nat’l University Hospital, Samsung Seoul Medical Center and Asan Medical Center, have won global certifications for their clinical study environment helping the country to build a clinical infrastructure on a global level. With this advanced infrastructure, Seoul became the third largest host city for global clinical trials, following Houston and San Antonio in the United States, in 2009. Seoul was also selected as Asia’s No. 1 destination for clinical trials in 2008 (338 cases in Korea, 135 in Singapore and 36 in Japan). The number of multinational regional clinical trials (MRCTs) conducted by multinational pharmaceutical companies in Korea has also increased sharply since the country introduced International Conference on Harmonization Good Clinical Practice (ICH GCP) in 2000. Especially, Pfizer formed a partnership with Korea as part of its global clinical program in 2008, selecting 4 of its 9 global Core Research Sites (CRSs) in Korea.

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[Manufacturing] High level of competitiveness and ability to generate rich pipelines of innovative drugs Pharmaceutical companies in Korea have been working to ensure that their drug manufacturing facilities meet rigorous global standards. To reflect global trends, the guidelines on Good Manufacturing Practices (GMP) changed from dosage forms to prior approval of individual items in 2008. As the guidelines shifted from management of dosage forms to that of individual items based on a step-by-step process through 2010, the quality assurance system for domestically manufactured drugs reached a global level. In addition, Korea has the ability to conduct drug R&D for compounds and commercial technologies, including organic synthesis, agents and global clinical trials. This ability was gained through development of generics and incrementally modified drugs. Korea is also a leader in the pharmaceutical biological technology area. With fruitful results from R&D including development of the world’s first stem cell therapy and xenotransplantation of pancreatic ducts, Korea is in an advantageous position to be a leader in promising future industries. The level of therapeutic technologies in cardiac surgery and management, and cervical cancer in Korea is the best among other OECD countries, according to OECD Health Data 2009.

Investments and strategic partnerships led by global pharmaceutical companies in Korea Pfizer, Merck, GSK, Novartis, AstraZeneca, Sanofi-Aventis and Otsuka are leaders in the global pharmaceutical industry which are aggressively investing in Korean pharmaceutical companies with potential. They are also expanding investments in areas that can make significant contributions to reinforcing technological competitiveness of the country, such as clinical trials, scientific research with universities and research institutes, non-clinical and early clinical research and investments in bio venture firms.

Leading Global Pharmaceutical Companies Investing in Korean Pharmaceutical Industry’s Potential Companies (Nationality)

The scale of Investment (Million USD, Period)

AstraZeneca (UK)

46 (‘06~’10)

Pfizer (US)

277 (‘07~’12)

Sanofi-Aventis (France)

65 (‘09~’13)

Otsuka (Japan)

92 (‘09~’13)

Novartis (Switzerland)

115 (‘09~’13)

Source: MOHW press release (2010)

In addition, Korean pharmaceutical companies have formed various forms of partnerships with multinational companies. More than 10 joint ventures, including Janssen Korea jointly established by Johnson and Johnson and Yuhan Corporation in 1983, have operations in Korea, and the number of licensing deals has also been increasing steadily. Dozens of licensing talks now involve more than 50 products and 20 technologies. Licensing deals with the world’s top 20 pharmaceutical companies particularly for the growing proportion of such deals.

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Public-private Partnership for Development of Pharmaceutical Industry Contributing to Global Health Korea aspiring to transforming itself into one of the top seven pharmaceutical powerhouses Korea has designated the pharmaceutical industry as one of the future growth engines. In order to foster the industry, the Korean government has been placing emphasis on enhancing growth potential through far-reaching policy measures, ranging from technology innovation to promoting market transparency, boosting global competitiveness of companies, and establishing infrastructure for sustainable development. Moreover, with knowledge and capacity mustered, the government, industry, medical society, and academic community are devoting themselves to make a leap forward into global markets. Under the circumstance where the Korean population has been aging rapidly, the Korean government has keen interest in the pharmaceutical industry, which serves as a foundation for the quality of life of the public. The government introduced “Accreditation of Innovative Pharmaceutical Company” in 2012, and will reinforce its efforts to support the industry every year with a view to reinventing the nation into one of the top seven pharmaceutical titans.

Introduction of Promotion and Support of Innovative Pharmaceutical Company What Company Can Be an Innovative Pharmaceutical Company? Special Act on Pharmaceutical Industry Promotion and Support (enacted in March 2011) serves as the legal foundation to designate innovative pharmaceutical companies verified to possess high R&D capacity for new drug development and to be globally competitive. Those companies are expected to play a leading role in developing the domestic pharmaceutical industry into a future growth engine.

Accreditation Process The Accreditation Screening Committee conducted written and verbal evaluations on candidate pharmaceutical firms which met the requirements (Article 2 of the Enforcement Decree of the Special Act: investment volume over a certain level). In the evaluations, the committee assessed candidate companies based on specific requirements, such as R&D performance in the past, company’s capacity, vision and investment plan, ethical business practice, etc. The results of the evaluations delivered by the screening committee were finalized after the review carried out by the Committee for Pharmaceutical Industry Promotion and Support, which is chaired by the Minister of Health and Welfare.

Composition of Designated Innovative Pharmaceutical Companies 36 general pharma firms: 26 leading firms that have marked high scores in terms of R&D investment as well as researchers, manufacturing facilities, patent and license-out, and overseas market advancing plus ten SMEs that have built on expertise in specialized areas such as development of incrementally modified drugs • Six bio venture companies: firms with relatively low sales but highly competitive technology and creative business models • One local corporation of a multinational pharma firm: one local company of an MNC considered outstanding in terms of R&D investment (in early clinical trials), local production performance, overseas market advancing, etc. •

List of Companies Certified as Innovative Pharmaceutical Companies [43] Category

Name of Company

General pharma firms (36)

Ahngook pharm.co.Ltd, Boryung Pharmaceutical co., Ltd., Bukwang Pharmaceutical Co., Ltd., Celltrion, Inc., Chong Kun Dang Pharmaceutical Corp., CJ CheilJedang Corp., Dae Hwa Pharmaceutical Co. Ltd., Daewon Pharmaceutical Co., Ltd., Daewoong Pharmaceutical Co., Ltd., DONG HWA PHARM, Dong-A Pharmaceutical, Dongkook Pharmaceutical, Green Cross Corp., HanAll BioPharma Co. Ltd., HANDOK Pharmaceuticals Co., LTD, HANLIM PHARM. CO., LTD., Hanmi Pharmaceutical. Co., Ltd., Hyundai Pharmaceutical Co., Ltd., ILDONG PHARMACEUTICAL CO.,LTD., IL-YANG PHARMACEUTICAL CO., LTD., ISU ABXIS, JW Pharmaceutical Corp., Kolma Korea Co., Ltd., Korea United Pharm. Inc., Kuhnil Pharmaceutical Co.,Ltd, Kwang Dong Pharmaceutical Co., Ltd., LG Life Sciences, Ltd., Samjin Pharmaceutical Co., Ltd., Samyang Biopharmaceuticals Corporation., Samyang Genexbio Corporation, SHIN POONG PHARM. CO., LTD, SK Biopharmaceuticals Co., Ltd., SK Chemicals Co. Ltd., ST Pharm Co., Ltd., TAEJOON PHARM. CO., LTD., Yuhan Corporation

Bio venture companies (6)

Medytox, BCWORLD PHARM. CO., LTD., Binex Co., Ltd., BIONEER CORPORATION, CrystalGenomics, Inc., VM BioPharma

Local corporation of a multinational pharma firm (1)

Korea Otsuka Pharmaceutical Co.,Ltd.

Excellence of Accredited Companies As of 2012, 43 firms selected as innovative pharmaceutical companies have 671 pipelines of new drugs, expected to develop 30 new drugs by 2020. The volume of R&D investment made by those companies amounts to KRW 1.3 trillion as of 2012 and it is projected to increase at a CAGR of 13.2% to approximately KRW 3.9 trillion by 2020.

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Pharmaceutical

For a Better Life

Ahngook pharm.co.Ltd

The 50 years old leading R&D oriented Korean pharmaceutical manufacturer/ Distributor/Exporting/licensor company. Mainly focusing on Respiratory/GI/Cardio/NSAID. Nominated as one of the leading innovative R&D company in Korea by government. A variety of licensing/importing opportunity (New Antitussive/Expectorant, Modified GI modulator/Chiral PPI tablet form, Syrup type Dexibuprofen and so on) Ahngook pharm is the top respiratory field market leader in Korea with Synatura syrup and Anycough cap. Not only Ahngook has been focusing on respiratory syrup but also big market player in cardiovascular field with Levotension (S-amlodipine tablet). Also, Ahngook has been launching new and differentiated drugs in the market with strong R&D capability. Ahngook’s financial status is very sound and stable with sound cash flow and profit. Likewise, Ahngook is one of the most promising pharmaceutical companies in Korea.

Brief Company Profile

Synatura Syrup

· Founded in 1959 · Main Business areas : Pharmaceuticals, Diagnostic Medical Devices, Cosmetics and Export · Sales : KRW 121 Bil.(USD 110 M in 2011) · Employees : 471 Persons

· HQs is located in Seoul · Central Reseach Center and General Plant are located in Gyeonggi-do · Representatives - Mr. June-Sun Auh : Chairman - Mr. Jin Auh : CEO & President

Brief History of Ahngook Year Anycough Cap.

Levotension Tab.

1959 1969 1986 1994 1998 2000 2005 2006 2009 2010 2011

Letopra Tab.

2012

Milestones Established Mr. June-Sun Auh joined as President Completion of the Korea GMP Facility Launching of Tobicom-s(Eye-nutrient) / Selected as ‘the HIT product’ of the year Mr. Jin Auh was named CEO & President Launching of Prospan and Listed on KOSDAQ Approval of BGMP synthetic Facility by KFDA Launching of Levotension (the first S-amlodipine in Korea) for the treatment of hypertension Groundbreaking of New GMP facilities “Anycough”(Novel Antitussive) was launched in July, 2009 50th Anniversary ceremony held Out-licensing of Anycough to Biocopea (UK), June 7th. 2010 Launching of Synatura, new herbal formulation Co-Promotion agreement for Zaditen of Novartis Korea Co-Promotion agreement for Harnal-D(BPH) and Vesicare(OAB) of Astellas Korea In-licensing of Lupapin & Export MOU of Synatura Nominated as ‘the innovative pharmaceutical company’ by Korean Ministry of Health.

CONTACT US James S.Y.Cheon Vice President / Global Business Division • Phone : +82-2-3289-4348 • Fax : +82-2-849-4123 • E-mail : [email protected]

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· Company · CEO · Specialty · Location · Homepage

Ahngook pharm.co.Ltd Jin Auh Pharmaceutical Manufacturer, Distributor, Exporter 993-75, Daelimdong, Yongdeungpo, Seoul, Korea www.ahn-gook.com

Pharmaceutical

Towards Global Standard R&D for Healthcare Products

BCWORLD PHARM. CO., LTD.

BCWORLD PHARM is a technology-driven pharmaceutical company in Korea whose expertise in formulation and process development enables it to provide quality generics as well as value-added novel formulation products. BCWORLD PHARM strives to establish its position as a pioneer in developing value-added pharmaceuticals through cutting-edge formulation technology including immediate/controlled release as well as fast-dissolving DDS, combined formulation, gastro-retentive system and depot formulation by way of proactive investments in R&D and strategic alliances. Recently BCWORLD PHARM not only has been certified as Korea Innovative Pharmaceutical Company (KIPC) by Korea Ministry of Health & Welfare but also designated as Advanced Technology Center (ATC) by Korea Ministry of Knowledge Economy.

Main Products Therapeutic Class CILACIN INJ.

MEROGEL

Products

Antibiotics (Carbapenem) Anti-Infectives Hyperlipidemia Anti-Osteoporosis Agents Anti-Hypertensives GI Agents Narcotics

Mepem Inj., Cilacin Inj. etc. Merogel Gel, BC Itraconazol Tab., etc. Starova Tab., BC Atorvastatin Tab. etc. Pamiron Inj., Risidro Tab. Ibertan Tab., Ibertan Duo Tab., Duomax Tab. etc. Mucopid Tab., BC Ranitidine Inj. etc. Remiba Inj., BC Morphine Sulfate Inj., BC Fentanyl Inj. etc.

R&D Pipeline PAMIRON INJ.

CONTACT US David Kim, Director Overseas Business Department • Phone : +82-2-2182-0466 • E-Mail : [email protected] • Head Office : 78 Gaepo-ro 22gil Gangnam-gu, Seoul, Korea Myung-Kwan Chun, PhD., Director Research Planning Team • Phone : +82-31-628-0921 • E-Mail : [email protected] • GRI : A-3, Korea Bio Park, 694-1 Sampyeong-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea

Category

Item

Indications

Stage

GRS Combination Microsphere Microsphere Microsphere Microsphere SR SR Prodrug Liposome

BCWP_A001 BCWP_C001 BCWP_D001 BCWP_D003 BCWP_D009 BCWP_D011 BCWP_E003 BCWP_E004 BCWP_P001 BCWP_Y001

Antibiotic Hyperlipidemia Anti-cancer Anti-cancer Schizophrenia Diabetes Psychostimulant BPH Anti-cancer Anti-cancer

Phase I (Korea) Preclinical Formulation Preclinical Preclinical Formulation Formulation Preclinical Preclinical Formulation

· Company · CEO · Specialty · Location · Homepage

BCWORLD PHARM. CO., LTD. Steve H. Hong · DDS-oriented Pharmaceutical Company · Therapeutic categories such as pain, anesthesiology, neurology, and musculoskeletal diseases 78 Gaepo-ro 22gil Gangnam-gu, Seoul, Korea www.bcwp.co.kr

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Pharmaceutical

Bio Base Camp for Biopharmaceutical Industry

Binex Co., Ltd.

Since its establishment in 1957, Binex has been dedicated to providing sustainable solutions to healthcare challenges in Korea. Binex is currently comprised of three main business sectors: biologics, chemicals, and cell therapy. As the only biologics CDMO in Korea, Binex plays the key role in solving the manufacturing bottleneck of biopharmaceutical industry by its hands-on experience on most blockbuster biologics and a top-notch biomanufacturing facility in compliance with the US and EU-GMP regulations. Binex have acquired several biosimilars in our pipeline available for overseas co-business and co-development. We are also looking for biopharmaceutical products to license-in and commercialize within the territory of our expertise.

Products Product Name

Indications

Status

Human Growth Hormone

Growth Hormone Deficiency

Currently Marketed

Human Growth Hormone is available in both vial and pen-type cartridge.

R&D Pipeline Product Name

Indications

Status

Remicade Biosimilar

Rheumatoid Arthritis, etc.

Phase 1

Remicade is one of the top selling biologics with $8.5 billion in sales in 2011. This monoclonal antibody drug has a broad indication including Rheumatoid Arthritis and other inflammatory conditions. Currently, this Remicade Biosimilar is under clinical phase 1 study with RA patients in both Korea and Japan.

CONTACT US Bo Seul (Helen) Noh • Phone : +82-32-850-3259 • E-Mail : b [email protected]

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· Company · CEO · Specialty · Location · Homepage

Binex Co., Ltd. Myoung-Ho Jeong Biologics (including biosimilars), chemicals, cell therapy, CDMO (contract development manufacturing organization) 368-3, Dadae-ro, Saha-gu, Busan, 604-846 Republic of Korea http://www.bi-nex.com

Pharmaceutical

A Leading Biotech Company

BIONEER CORPORATION

Bioneer, an innovative biotech company since 1992 Leadership in RNAi Therapeutics: Bioneer Corporation is Korea’s leading biotech company. Bioneer was the first Korean biotechnology company when it was established in 1992. The company has developed state of art molecular biology products and technologies including oligonucleotides/siRNA and instruments of gene manipulation. The company is positioned to fully-integrate its capability to develop next generation technologies in the post-genome era through the invention of new biochemistry and instruments. By capitalizing on the foundational technologies and products developed over 10 years, Bioneer has developed a solid vertically integrated infrastructure to support new higher value-added businesses such as novel RNAi drug development and molecular diagnostics.

Bioneer’s siRNA Drug Development Program using SAMiRNA Technology SAMiRNA (Self-Assembled-Micelle-inhibitory-RNA) is a novel class of RNAi molecule consisting of RNA, lipid and PEG, which is stable nanoparticle in blood stream and efficient in vivo delivery and finally converted to siRNA in the target cells. SAMiRNA is a SCE (single Chemical Entity), which is manufactured by the proprietary solid-phase synthesis that greatly simplifies the manufacture and QC process relative to other state-of-the-art RNAi delivery platforms. SAMiRNA overcomes major challenges for safe and effective siRNA delivery as well as adverse effects of delivery vehicle. SAMiRNA itself includes its flexibility to incorporate siRNA sequences against any disease target, as well as enhancement of its therapeutic potential as a targeted delivery by the addition of cell-type specific ligands on SAMiRNA. These features and pre-clinical research data suggest that SAMiRNA is the most unique and singularly effective RNAi prodrug system developed to date. Vertically integrated processes within Bioneer’s siRNA Drug Development Program provide a total solution for siRNA therapeutics discovery and development, from siRNA design/synthesis and preclinical tests to IND filing. With its world-class RNAi core technologies and manufacturing infrastructure, Bioneer is the ideal partner for pharmaceutical and biotechnology companies currently working on the development of RNAi therapeutics, or seeking to enter the RNAi field. Bioneer’s research and technical support teams which have more than 10 year experience ensure top-quality products and developments to meet unmet therapeutic needs.

R&D Pipeline Bioneer is currently advancing clinical development of pipeline programs for previously non-druggable targets, including cancer, COPD, liver fibrosis, and antivirals, internally with our research and development resources as well as through partnerships with major global pharmaceutical companies. Programs

Discovery

Development

Preclinical

Phase I

Clinical Trials Phase II Phase III

BIONEER PROGRAMS Solid Cancers

(SAMiRNA-Survivin)

COPD Liver Fibrosis Antivirals PARTNER PROGRAM Liver cancer SANOFI

CONTACT US Jei-Wook Chae, Ph.D. , Head of R&D Genomic New Drug Division • Phone : +82-42-930-8573 • E-Mail : [email protected]

· Company · CEO · Specialty · Location · Homepage

BIONEER CORPORATION Han-Oh Park, Ph.D. Molecular Diagnostic, Genomic New Drug, Genomic Science, Synthetic Vaccine 49-3, Munpyeong-dong, Daedeok-gu, Daejeon 306-220, Korea www.bioneer.com

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Pharmaceutical

Total Healthcare Company Contributing to the Human Health

Boryung Pharmaceutical co., Ltd.

Since its founding in 1963, Boryung Pharmaceutical Company has been trying its best to contribute to the health and wellbeing of humanity with its corporate mission to ‘realize mutual health and co-prosperity based on human centered values’. Boryung has conducted the R&D activities to develop drug substances from a short-term perspective and to develop new drugs for future market from a mid- to long-term perspective. In particular, Boryung Pharmaceutical makes an effort to strengthen the product pipelines in the specialty areas such as cardiovascular drugs, antineoplastics drugs and antibiotics/antiviral. Boryung will devote itself to achieving aspiration of the company which is “Dedicating to the Health of Mankind” and becoming a global innovative pharmaceutical company.

Products KanarbⓇ (Fimasartan)

Kanarb

Boryung Pharmaceutical has developed Kanarb®, an anti-hypertensive drug that has been approved by the KFDA as the 15th new drug. It is now on sales in Korean market and it has exceeded 10 billion won at the first year of release. Kanarb® is one of the ARBs that are used the most frequently to treat patients with hypertension, and it has been developed based on the mechanisms that the blood pressure can be lowered by hindrance of angiotensin to bind type 1 receptor which is involved in the elevation of blood pressure. Until now, Kanarb® had its patent registered in 14 worldwide countries and it was also awarded with Korea Technology Awards by the Ministry of Knowledge Economy and ‘Oh Song New Drug Prize’ by the KFDA in 2011. Boryung is in the process of exporting Kanarb to 13 countries in South America and it is moving to make export deals with China, Southeast Asia, the U.S., and Europe, proudly representing Kanarb. Kanarb combination Kanarb combination is a drug composed of Kanarb (ARB) and diuretics. Boryung recently completed Phase III clinical study and is preparing NDA for launching in 2013.

R&D Pipeline Therapeutic area CV NCE AN Biologics

IMD

CNS GI

CONTACT US Ji Hyun Min R&D strategic planning • Phone : +82-2-740-4019 • E-mail : [email protected]

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Product BKC 001 BKC 002 BKI 001 BKI 002 BCN 001 BCI 001 BCSI 001 BAB 001 BVN 001 BNI 001 BNT 001 BNT 002 BGE 001

RS

PC

PI

PII

PIII

RG

○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

· Company · CEO · Specialty · Location · Homepage

Boryung Pharmaceutical co., Ltd. Kwang Ho, Kim Full ingredient Pharmaceutical product and substance Boryung Bldg 66-21 Wonnam-dong, Jongro-gu, Seoul www.boryung.co.kr

Pharmaceutical

To Contribute to Society through Supplying Value-added New Products to Help Patients Suffering from disease

Bukwang Pharmaceutical Co., Ltd. Bukwang Pharmaceutical Co., Ltd. is one of the innovative pharmaceutical companies in Korea and was founded in 1960 with dedication to development and commercialization of novel, outstanding medicines. Bukwang has successfully achieved remarkable growth for over fifty years. Now Bukwang has 520 employees or so, with over 180 billion Korean won of net sales in fiscal year 2010. Through many years of effort, ‘Levovir® cap. (clevudine)’, the 4th drug worldwide for hepatitis B virus, was finally approved by KFDA in 2006, and it is the 11th New Drug developed in Korea. Levovir® was licensed out to Eisai, a Japanese company, and they paid 44 million dollars for the license of clevudine in Asian countries including China. Bukwang reinvests a part of its profit for continual development of new products. Several projects for developing new medicines are ongoing in the R&D center. Bukwang will use its novel tools and technologies to attain a prominent market position in the pharmaceutical industry field, increasing its business profitability and the value of the company while providing effective new solutions to incurable diseases and fundamental biological processes.

Products Levovir® cap.(clevudine) : an innovative new drug for chronic hepatitis B virus) Levovir

Levovir was developed by Bukwang and it is the 4th drug developed for HBV infection worldwide, and the 11th new drug in Korea. It is potent in suppression of hepatitis B virus and it has excellent safety and tolerability profiles.

R&D Pipeline Targeted anti-cancer agent (apatinib mesylate) - Phase III clinical trial for colorectal cancer and lung cancer completed in China - Phase I/II approved in USA as well as in Korea Antivirus drug for hepatitis B virus - Combination drug of clevudine and adefovir dipivoxil to maximize the effectiveness of treatment and to inhibit resistant virus reciprocally - New drug: gained development right for prodrug and exclusive sales rights worldwide from Georgia University, USA. Novel antivirus drug for Herpes Zoster - License agreement of a new substance called “L-BHDU” - New synthetic substance collaborated by Georgia and Yale University, USA Diabetic neuropathy drug - New drug using only a stereoisomer of thioctic acid - Completed phase III trial CONTACT US Choi, In Ae Product Development • Phone : +82-2-8288-078 • E-mail : [email protected]

· Company · CEO · Specialty · Location · Homepage

Bukwang Pharmaceutical Co., Ltd. Lee, Sung Koo Pharmaceuticals and sanitary aids 398-1, Daebang-dong, Dongjak-gu, Seoul, Korea http://www.bukwang.co.kr

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Pharmaceutical

A Global Technology Leader in the Field of Biosimilar and Biologic Drug Development

Celltrion, Inc. Celltrion's goal is to provide affordable alternatives to the high-priced antibody drugs, price of which limits broad usage of the drugs. Celltrion prides itself in being the first company in the world to apply for global regulatory approval of an antibody biosimilar. We are using our accumulated R&D technology and manufacturing capabilities to develop, manufacture and market life changing antibody biosimilars and innovative drugs to patients in need. Celltrion hopes that more suffering patients will be able to have access to and benefit from the new availability of advanced biomedicines.

Products Celltrion has received approval from the Korean Food and Drug Administration (KFDA) for Remsima (infliximab), which is a monoclonal antibody against tumor necrosis factor alpha (TNF- α) used to treat autoimmune diseases. Remsima is the world's first antibody biosimilar to receive regulatory approval based on global clinical trials. The KFDA approved Remsima for the same indications as the originator, including rheumatoid arthritis, ankylosing spondylities, ulcerative colitis, Crohn's disease, psoriasis. Remsima will also be automatically approved for the treatment of pediatric ulcerative colitis upon completion post marketing surveillance of original drugs. With the approval of Remsima, Celltrion, Inc. has gained entry into the $24 billion TNF- α antagonist market and is likely to be the only biosimilar product in the market for the next 4 to 5 years.

R&D Pipeline Celltrion currently has 8 biosimilars candidates in various stages of development. The CT-P6 (Breast Cancer) Project is in their most advanced stages of development, successful completion of clinical trials conducted in over twenty countries. PROJECT CT-P06 - Indication: Metastatic and early breast cancer that over express HER2 gene (Protein Type: mAb) PROJECT CT-P10 - Indication: Rheumatoid arthritis, Non-Hodgkin’s lymphoma (Protein Type: mAb) As a company specialized in antibody drug development, Celltrion is also developing innovative antibody drugs to overcome the limitations of existing vaccines and synthetic drugs for pandemic or seasonal influenza viruses. The results of animal tests conducted by the US Center for Disease Control and Prevention showed that this new antibody drug may be effective in treating avian influenza, influenza A and many other variations of influenza viruses. Thus, this new drug is expected to become the world’s first comprehensive influenza virus treatment antibody, if succeeded.

CONTACT US Celltrion Headquarters • Phone : +82 32 850 5008 • Fax : +82 32 850 5057 • E-mail Business : [email protected] Investment : [email protected] Career : [email protected]

14

Additionally, Celltrion is developing innovative drug to cure rabies by collaborating with the US Center for Disease Control and Prevention. Celltrion is also working with a US biotech company to develop an antibody drug that is expected to be a cure for breast cancer and lung cancer. Other than the antibody drugs pipeline, Celltrion is focusing on developing antibody-drug conjugate that minimizes side effects and maximizes efficacy by integrating antibodies with synthetic drug substances. Celltrion’s broad innovative drug pipeline is expected to serve as the driving force behind Celltrion’s future growth.

· Company · CEO · Specialty · Location · Homepage

Celltrion, Inc. JungJin Seo biopharmaceutical development and manufacture 13-6, Songdo-dong, Yeonsu-gu, Incheon, 406-840, South Korea www.celltrion.com

Pharmaceutical

BINT Medicine R&D Corporation for Terminal Illnesses (BINT: Bio-Info-Nano Technology)

Chong Kun Dang Pharmaceutical Corp. Chong Kun Dang Pharmaceutical Corp. (CKD) was established with the objective of supplying the best quality medicine to the people who need them and performing its business activities for the development of pharmaceutical industry in Korea for over 70 years since its inception in May 1941. Products

Lipilou tab., anti-hyperlipidemic agent

In 1968, CKD obtained US FDA approval for Chloramphenicol, Chloramphenicol palmitate and sterile Chloramphenicol sodium succinate. It was the first commemorative US FDA approval for raw materials in Korean pharmaceutical industry. In addition, CKD has gained additional US FDA approvals for raw materials such as Oxytetracycline hydrochloride, Tetracycline, Rifampicin, Demeclocycline and so on. Since exporting antibiotics to Japan in 1969, CKD has acted as a pioneer of Korean pharmaceutical companies by entering more than 40 overseas markets with the finished products such as Rifampicin, anti-tuberculosis drug. In R&D, CKD was the first company to establish a Research Institute in 1972 among Korean pharmaceutical companies. Through continuous research, CKD had succeeded in the development of many specialty products such as Cipol N® (ciclosporin) and TacroBell®(tacrolimus), immunosuppressive agents for organ transplantations. Such successful developments brought CKD a variety of awards such as Korea Technology Mark and Technology Research Institute Prize. In 2008, CKD’s Lipilou®(atorvastatin), a treatment for high cholesterol was awarded as Korea Technology Gold Prize, and its new formulation and process improvement of atorvastatin were evaluated as Korea’s 10 New Technologies.

Camtobell inj., anti-cancer agent

R&D Pipeline CKD has focused on the research and development of new medicines and incrementally modified drugs (IMDs). In the field of new medicines, CKD has developed Camtobell® Injection, CKD's first new chemical entity, and achieved Korea Food & Drug Administration (KFDA) approval for the treatment of small cell lung cancer and ovarian cancer in 2003. CKD is developing a variety of new medicines in broad stages such as CKD-501, oral anti-diabetics under NDA review and CKD-516, anti-cancer drug in phase 1. CKD-501 (lobeglitazone), a potent peroxisome proliferatoractivated receptor-y (PPAR-y) agonist, is being developed for the management of type-2 diabetes. Unlike other glitazones, lobeglitazone shows significant safety profile in cardio-toxicity and bladder cancer. Lobeglitazone is likely to be approved in Korea by the end of 2012. Furthermore, CKD-732 which was licensed out to Zafgen is being developed as an anti-obesity drug. In case of IMD, CKD is focusing on the development of combination products and the drug delivery system for a new type of oral antibiotics and nanoparticles. In the 21st century, CKD will devote itself to becoming a world-class pharmaceutical company under its motto “Better Life through Better Medicine”. CKD’s great dedication and service will be continued for the welfare of all mankind.

CONTACT US Indy Baik, Team Manager Int’l Sales & Marketing Division • Phone : +82-2-3149-7849 • E-Mail : [email protected]

· Company · CEO · Specialty · Location · Homepage

Chong Kun Dang Pharmaceutical Corp. Jung Woo Kim R&D of new medicine and incrementally modified drug (IMD) 368, 3-ga, Chungjeong-ro, Seodaemun-gu, Seoul, Korea www.ckdpharm.com

15

Pharmaceutical

Global Food & Bio Company

CJ CheilJedang Corp.

CJ PHARMA Toward a No.1 Pharmaceutical Company in Korea CJ started Pharmaceutical business from 1984, to improve people's quality of life and resume patients' health. In line with CJ's corporate vision, CJ Pharma has been striving for making people healthier, happier and better convenient with innovative and differentiated pharmaceutical products. Now, CJ Pharma has become a representative Korean pharmaceutical company in promising therapeutic areas such as oncology, cardiology, endocrinology and nephrology. CJ Pharma is working hard to grow globally, focusing on rapidly growing China and Southeast Asian markets as well as highly-regulated but attractive Japan and EU markets. Through our newly established cGMP applicable plant in Osong, CJ Pharma can secure global standard manufacturing facilities and operation capabilities. CJ Pharma will make its best efforts to jump into a leading position among global Pharmaceutical Companies.

Products 1. Epokine -1st in Korea and 3rd in the world Epokine® is safe and effective in treating anemia of hemodialysis patients withend-stage renal disease 2. Leukokine - Leukokine® has the same efficacy and safety with those of the control on neutropenia 3. Vancomycin - Vancomycin® is the best choice for MRSA & MRSE. 4. Tapocin - Tapocin® is the first choice for the treatment of MRSA, MRSE and Enterococcus 5. CJ CONDITION - CJ CONDITION has launched in 1992 creating a new market of anti-hangover drink in Korea. 6. Hongsamjin-Gold - Produced with 6-yeared red ginseng with the most outstanding therapeutic effects 7. Hutgaesoo (Oriental Rasin Tea) - Hutgaesoo also contains the goodness of 100% arrowroots with its digestive benefits.

Global Business 1. China - Vancomycin Inj./ Teicoplanin Inj 2. Japan - Cefotiam , Cefmenoxime, Ceftriaxone inj., Ceftazidime inj. 3. Southeast Asia - EPO, GCSF, Vancomycin Inj, Tamsulosin, Levofloxacin Inj, Mycophenolate Cyprofloxacin Inj, Amlodipine, Teicoplanin Inj, Simvastatin 4. Africa - EPO 5. Middle East Asia - Ceftriaxone Inj, EPO, Vancomycin Inj 6. Latin America - EPO, Vancomycin Inj, Mycophenolate, Teicoplanin Inj, Topiramate, Donepezil

R&D Pipeline Product

Phase

Therapeutic Area

CJ-30001 CJ-20001 CJ-12420 CJ-12406 CJ-12433 2nd Generation EPO 2nd hGH

PIII PII PI PI Pre Clinical Pre Clinical Pre Clinical

Diabetes Gastritis GERD, Licensed H. pylori eradication, Licensed Functional Dyspepsia, Licensed Anti-Anemia Growth Hormone

CONTACT US Kwang Hee Hong, PhD, MBA Head/Licensing, Pharmaceuticals BU • Phone : +82-2-6740-2181 • Mobile : +82-10-3035-7579 • E-mail : [email protected]

16

· Company · CEO · Specialty · Location · Homepage

CJ CheilJedang Corp. Chul ha Kim ETC (CVs, Antibiotics, IV Solution, Oncology, Endocrinology, Nephrology&Urology, Gastro Intestinal, Musculo skeletal, Respiratory, Others), OTC CJ Cheiljedang Bldg. 292, Ssangrim-dong, Jung-gu, 100-400, Korea www.cjp.co.kr

Pharmaceutical

Clinical Stage Biotech Company with Robust Pipeline and Proven Track Record in Discovery and Development of Novel Drugs

CrystalGenomics, Inc. CrystalGenomics Inc., is a leading structural chemoproteiomics-based drug R&D company headquartered in Korea with a US subsidiary for multi-national clinical management (CG Pharmaceuticals, Inc.) in Emeryville, California. CrystalGenomics is devoted in discovery and development of novel therapeutics in the disease areas of great unmet need including inflammation, infectious disease, and oncology.

Products · CG100649 - A novel NSAID for osteoarthritis with tissue-specific mechanism of bypassing problematic tissues (e.g. GI & CV) by binding to carbonic anhydrase enzymes in these tissues and only inhibiting COX-2 enzymes in the desired target tissues (e.g. joints, knees, hips) where carbonic anhydrase is absent. - Recently completed a Phase IIa study in Europe and Phase IIb study in Korea. - CG100649 is believed to offer both gastrointestinal and cardiovascular safety which has limited the use of the traditional NSAIDs and COX-2 inhibitors. · CG400549 - A novel Antibiotic for MRSA & VRSA (in Phase IIa development in USA) - FabI inhibitor - Interrupts fatty acid synthesis process that is only found in bacteria and seems to be an excellent drug candidate for the “Superbugs”. · CG200745 - A molecular target cancer therapy agent (in Phase I development in Korea) - This compound targets HDAC and shows superb efficacy so far in its early development stage

R&D Pipeline

CONTACT US Steven Kim, RPh MBA, Director, Business Development • Phone : +82-31-628-2720 • E-mail : [email protected]

Area

Candidate

Indication

NCE Type

NSAID

CG100649

Osteoarthritis

FIC1

Antibiotic

CG400549

MRSA/VRSA

FIC, BIC2

Cancer

CG200745

Cancer

BIC

· Company · CEO · Specialty · Location · Homepage

Preclinical

Ph I

Ph II

Ph III

CrystalGenomics, Inc. Joong Myung Cho, Ph.D. Novel Drug Discovery & Development 5F, Tower A, Korea Bio Park 694-1, Sampyeong-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, 463-400, Korea www.crystalgenomics.com

17

Pharmaceutical

Respecting Life & Serving Society

Dae Hwa Pharmaceutical Co. Ltd.

DAE HWA has developed all kinds of medicines ranging from peptic ulcer medicines to preventive and assistant treatments including a cancer, adult related disease, etc. We also have a specialty of TDDS (Transdermal Drug Delivery System) patches which are being used in Loxona, Resnalin, Kebanon, etc. DAE HWA established pharmaceutical raw material synthesizing facilities and a plant of CGMP level in order to build a healthy welfare society by developing better-quality medicines.

Products

Aceren capsule

Resnalin patch

Kebanon plaster

Our sales turnover was around 70 million dollars in 2011 and we have been exporting around 15 countries. mainly Southeast Asia, South America and Africa. We have been doing business with Vietnam for more than 15 years and established representative office in 2006. For creating new markets, we put more effort on CTD documentation as well as finding potential business partner. As a result, we are about to export bug bite patch to America in this year and 2 products are in the process of registration in China. Followings are our main products. - Aceren capsule (Diacerhein): Rheumatoid arthritis, osteoarthritis - Resnalin patch (Tulobuterol): Bronchial asthma and sepsis - Kebanon plaster/cataplasma (Ketoprofen): Traumatic inflammation of muscles, strains and sprains - Flospan tablet/solution (Phloroglucinol): Renal and urinary colic hepatic, gall bladder and spasmodic colic, intestinal colic and dysentery syndrome - Cephamethyl tablet capsule (Methylol cephalexin lysinate): Bronchiectasis, bacterial pneumonia, otitis media, mastoiditis, paranasal sinusitis, tonsillitis, pharyngitis etc. - Protase tablet (Bromelain, Crystallized Trypsin): Fracture, sprain, internal, external and incarcerated hemorrhoid after proctoptosis, hemorrhoidal surgery, hematoma and thrombosis - Warfarin tablet (Warfarin sodium): Phlebothrombosis, embolism, pulmonic embolism and coronary artery occlusion

R&D Pipeline Flospan tablet

We have 3 factories and 3 laboratories. The 1st factory is for producing tablet, ointment, etc, and The 2nd factory is for transdermal products. the 3rd factory is mainly for law material synthesis study and manufacturing. Currently following products are under development; Voglibose (glucose-lowering), Sildenafil ODF (erectile dysfunction), Tadalafil raw material (erectile dysfunction), Rivastigmine (Anti-dementia drugs) Nicotinate (Anti-smoking aids) etc. We are also proud of our anticancer drug DHP107, which developed the paclitaxel, a medicine used formerly only for injections that now can be used orally, and this is the world’s only single agent that oral paclitaxel does not have an absorption enhancer. Moreover, we are continuing our research on transdermal products using the drug delivery system (DDS) technology.

Cephamethyl tablet/capsule

CONTACT US Hanwoong, Seo +82-2-6716-1071 Paul, Cho +82-2-6716-1072 Serena, Hwang +82-2-6716-1073

18

· Company · CEO · Specialty · Location · Homepage

Dae Hwa Pharmaceutical Co. Ltd. Han Koo, Lee Medical products Seoul www.dhpharm.co.kr

Pharmaceutical

Reliable Partner for Human Health

Daewon Pharmaceutical Co., Ltd.

Be a partner who protects healthy life of human beings based on reliability and trust of customers. Since the establishment in 1958 with a founding idea of "Realization of human health", Daewon Pharm. Co., Ltd. has made the best efforts for human health and happiness through manufacturing and providing specialized medicines. We produce reliable and safe medicines by securing world-class manufacturing facilities and superior R&D capabilities. Hyangnam GMP Plant The Hyangnam factory of Daewon Pharm. Co., Ltd. is equipped with superior manufacturing facilities and quality management system and has produced over 150 of medicines, such as solid dosage medicines, liquid dosage medicines, injectable medicines, sex hormone medicines and so on. The Hyangnam factory of Daewon Pharm. Co., Ltd. secures competitiveness to manufacture world-class products with cutting-edge facilities, in conformance to the cGMP (Current Good Manufacturing Practice) criteria. Research and Development The Central research institute of Daewon Pharm. Co., Ltd. has been developing ETC products in various areas and, finally, in 2007 our research endeavor achieved the dream of developing a new chemical entity which upgraded our institute's position to the global level. Gwanggyo R&D Center and Gunja R&D Center as the center figure, Daewon Pharm. Co., Ltd. has sought to strengthen research and development capability and the product pipeline. Export With its first export to Vietnam in 1994, Daewon Pharm has made eye-opening achievements of exports. Now, we export our products to 35 countries such as China, Latin America, Middle East, CIS, and Africa. Daewon is exporting about 50 products and is expanding its export volume with products such as Pelubi tablet, a new chemical entity, and Oramin Capsule, multi-vitamin supplement with Korean Ginseng. Oramin Capsule

Products Oramin Capsule

Pelubi tablet

World’s favorite multivitamin, Oramin Cap., by Daewon contains high quality Korean ginseng and royal jelly as well as all sorts of vitamin and minerals necessary for vital daily life. Oramin, our representative global brand, demonstrates the superiority of Korean ginseng all over the world, being ranked first out of multivitamin brands in 4 countries. Pelubi tablet(the 12th new medicine in Korea)

CONTACT US Andy Lee • Phone : +82-2-2204-6971 • E-mail : [email protected] SinHo Choi • Phone : +82-2-2204-6975 • E-mail : [email protected]

The Pelubi tablet, a series of NSAIDs, was developed in the whole process from raw materials to end product only by Daewon Pharm. Co., Ltd., and certificated as the 12th new medicine by Korean Food and Drug Administration. It is a highly effective NSAIDs for pain relief which has less side effects than existing NSAIDs products.

· Company · CEO · Specialty · Location · Homepage

Daewon Pharmaceutical Co., Ltd. Baek, Seung Ho / Baek, Seung Ryel Drug manufacture and sales 229-3 Yongdap Dong, Sungdong-Gu, Seoul, Korea www.daewonpharm.com

19

Pharmaceutical

Pharmaceutical Company with the No.1 Sales of Prescription Drugs in Korea

Daewoong Pharmaceutical Co., Ltd. Daewoong Pharmaceutical is the No. 1 seller of prescription drugs in the Korean market. Established in 1945, Daewoong Pharmaceutical Co., Ltd. is the largest seller of prescription drugs in Korea. Daewoong operates the best manufacturing facilities and has professional expertise in marketing and sales promotion, as well as capacity for R&D and an efficient management system. In collaboration with multi-national pharmaceuticals, it makes every effort to launch the-state-of-the-art pharmaceutical products and medical devices to the global market. Presently in 2012, Daewoong has the largest number of blockbuster products among Korean pharmaceutical companies. This fact casts Daewoong in a pivotal role for the Korean pharmaceutical market and extends its marketing scope to the overall Asian market including China and Southeast Asia. In addition, Daewoong is also currently working to enter the EU and USA markets. The reinforcement of R&D capacities through the establishment of R&D centers in China, India and the USA. Daewoong Pharmaceutical Co., Ltd. has strengthened its R&D capacities on a global scale through the establishment of R&D centers in China, India and the USA in addition to Korea. The Daewoong R&D center in Korea is working to develop biological new drugs and incrementally modified drugs, as well as new chemical entities (NCE). The India research center in Hyderabad, India is managing the release of global products, developing new pharmaceutical technology and conducting global clinical trials. In addition, the R&D center located in China focuses on the development of new pharmaceutical technology and the introduction of natural new drugs. The US corporate location in Rockville, Maryland plays a strategic role in the establishment of Daewoong Pharmaceutical Co., Ltd. as a global pharmaceutical manufacturer and a hub for the distribution of Daewoong products.

R&D Pipeline New Chemical Entities Code

MOA

Description

DWP05195 DWP10019 DWP09031 DWJ205 DWJ206 DWJ208

TRPV1 Antagonist DNA Pol Inhibitor Aggregation Inhibitor Fungicidal APA(Reversible) Ion Channel Blocker

Neuropathic Pain Hepatitis B Virus Infection Alzheimer Program Antifungal-Fungicidal Program Antiulcer Program Cancer Pain, Low-Back Pain

Code

MOA

Description

DWP418 DWP422 DWP438 DWP431

TERT-Specific Oncolysis TNF Blocker Therapeutic Antibody BMP-2

Gene Therapy-Oncolytic Adenovirus Anti-Rheumatioid Arthritis Fusion Protein Anticancer Monoclonal Antibody Osteogenic Bone Morphogenetic Protein

R

Development Status Pre Ph I Ph II Ph III

M

○ ○ ○ ○ ○ ○

Biologics

CONTACT US Early Stage Collaboration and License In/Out • Mr. Kangsik Yun, General manager, R&D Strategic Planning Team • Phone : +82-31-270-8320 • E-Mail : [email protected] Global Business Development and License Out • Mr. Seong ho Jeon, General Manager, Global Strategy Dept. • Phone : +82-2-550-8372 • E-Mail : [email protected]

20

R

Development Status Pre Ph I Ph II Ph III

M

○ ○ ○ ○

Incrementally Modified Drugs Code

MOA

Description

IMD-01 IMD-02 IMD-03 IMD-04

GI Motility Enhancer Hyperlipidemia/Hypertension Alzheimer’s Disease Erectile Dysfuction

Sustained Release Combination Drug Patch Chewable Tablet

· Company · CEO · Specialty · Head Office · Homepage

R

Development Status Pre Ph I Ph II Ph III

M

○ ○ ○ ○

Daewoong Pharmaceutical Co., Ltd. Lee, Jong Wook Small-molecule new drugs, biological new drugs, natural new drugs 163-3, Samsung-dong, Kangnam-gu, Seoul, Korea www.daewoong.com

Pharmaceutical

Oldest to Best

DONGWHA PHARM

Dong Wha Pharm, as Korea’s first and oldest pharmaceutical company, is pursuing the ultimate goal of pharmaceutical industry, which is the development of new drugs. Whal Myung Su, Korea’s first western-style medicine, by integrating the advantages of Western medicine into the royal court’s secret recipe in 1897, the first year of The Great Korean Empire. Furthermore, many pharmaceutical products such as Fucidin ointment, Lacteol and Pancold A etc., have been developed after Dong-Wha Pharmaceutical Research Institute was founded in 1973. Since present state-of-the-art laboratory building was built in 2010, it is now set to become a global hub for new drug development. The Chungju Industrial Complex (established in 2009) is equipped with equipment and facilities that satisfy Current Good Manufacturing Practice (cGMP) Regulations of US FDA. In addition, the plant has been evaluated as a worldclass pharmaceutical company by the installment of high-tech plant automation system. Utilizing multicomponent resources, Dong Wha strategizes to develop numerous superior medicines, the most advanced drugs and new pharmaceutical products.

Products A new quinolone antibiotic(PhaseIII completed) New fluoroquinolone antimicrobial agent (Zabofloxacin, DW224) has broad antibacterial activities. It has also excellent activities against RTI pathogen. Through preclinical and clinical studies, it shows good safety profile and the following advantages. 1) More active than any other Quinolones (in vitro, in vivo) 2) Highly active against respiratory tract infection pathogen (Gram(+); S.pneumoniae, S.aureus, S.pyogenes and M.catarrhalis) 3) Good safety profile (in mouse, rat and dog) 4) No phototoxicity

R&D Pipeline Project

Status

Characteristic & Merit •

Gram (+) resistant bacteria, respiratory tract infections, particularly pneumoniae

Zabofloxacin(DW224) Quinolones Antibiotics

PhaseII completed

DW1029 Diabetic nephropathy

Phase II

DW1350 Osteoporosis

Phase I completed

Perform a dual action mechanism - Inhibition of bone resorption - Promotion of bone formation • Superior safety

DW1006 Schizophrenia

Preclinical



Remark Licensing out to PBB (USA)

New herbal drug Excellent effect on diabetic nephropathy • Safety & low side effect • •



CONTACT US Moon Jeong Leem, Director • Phone : +82-2-2021-9580 • Email : [email protected] Jin Soo Lee, Director • Phone : +82-31-270-0601 • Email : [email protected]

Licensing out to Teijin (Japan)

Dopamine receptor antagonist

· Company · CEO · Specialty · Head Office · Homepage

DONGWHA PHARM Je Hwa Park 1) Antibiotic 2) Kidney disease 3) Osteoporosis 4) Schizophrenia 5 Soonwha-dong, Joong-gu, Seoul, Korea www.dong-wha.co.kr

21

Pharmaceutical

A Respected World-class Company through Innovative Pharmaceutical Products

Dong-A Pharmaceutical The No.1 pharmaceutical company in Korea Dong-A Pharmaceutical Co., Ltd. is the No.1 pharmaceutical company in Korea, with annual pharmaceutical sales of USD 769.8 million (KRW 846.8 billion) in 2010. From STILLEN to ZYDENA As for R&D, Dong-A was the first of its kind in South Korea to establish a research laboratory. Extensive, concentrated investments have been made in R&D to discover and develop innovative medicines, resulting in the launch of various products from STILLEN (Artemisia Extract, Gastritis) in 2002 to ZYDENA (The 4th PDE-5 inhibitor in the world, Erectile Dysfunction) in 2005. Innovative new drugs, biopharmaceuticals and new formulation products Currently, a wide range of research projects are in development, including innovative new drugs, biopharmaceuticals and new formulation products. For the global development of the research projects, Dong-A is also pursuing licensing-out opportunities and seeking potential partnerships that can share mutual benefits through the development of Dong-A’s pipeline in the overseas market.

R&D History Pipeline Code Name (Brand Name)

Indication

Description

Latest Phase

Licensing Availability

New Chemical Entity DA-8159 (Zydena®)

Erectile Dysfunction

PDE-5 Inhibitor

Launched (Korea) / Ph III (USA)

Some Territory Available

DA-8159

Portal Hypertension

PDE-5 Inhibitor

Ph II (Europe)

Some Territory Available

DA-8159

BPH

PDE-5 Inhibitor

Ph II (USA)

Some Territory Available

DA-8159

PAH

Ph II

Some Territory Available

DA-7218

Infection(ABSSSI)

DA-6034

Gastritis, Dry Eye

PDE-5 Inhibitor Oxazolidinone Class Antibiotic Flavone Derivative

Ph III / Ph II

Available

DA-1229

Type 2 Diabetes

DPP-4 Inhibitor

Ph II

Available

DA-8031

Premature Ejaculation

SERT Inhibitor

Ph I

Available

DA-9701

Functional Dyspepsia

Herbal Extract

Launched(Korea)

Available

DA-9801

Diabetic Neuropathy

Herbal Extract

Ph II

Available

Ph III (USA)

Phytomedicine

Pharmaceutical Products DA-3801 (Gonadopin®)

Infertility

Recombinant FSH

Launched (COH in ART) Ph III (Ovulation Induction)

Some Territory Available

DA-3030

Diabetic Neuropathy

G-CSF

Ph II

Available

DA-3031

Neutropenia

PEGylated-G-CSF

Ph III

Available

DA-3051

Multiple Sclerosis

Interferon-β

Ph III (Brazil)

Available

DA-3091

Type 2 Diabetes

Long-acting Exenatide

Ph I

Available

DA-3607

Brain Tumor

TRAIL

Ph I

Available

A-3803

Infertility

Recombinant hCG

Ph III

Available

CONTACT US E un-Ju Jang Deputy General Manager, Business Development & Out-Licensing Team. • Phone : +82-2-920-8212 • E-Mail : [email protected]

22

· Company · CEO · Specialty · Location · Homepage

Dong-A Pharmaceutical Won-Bae Kim ETC 252 Yongdu-dong, Dongdaemun-gu, Seoul, Korea www.donga.co.kr

Pharmaceutical

Human & Life

Dongkook Pharmaceutical

Dongkook Pharmaceutical is marching into the world with global competitiveness. For the past 44 years, Dongkook Pharmaceutical has made continuous efforts to uphold respect for life and healthy national lives on the basis of corporate philosophy of creativity, harmony and credibility. Since the company was listed on the KOSDAQ in May 2007, Dongkook Pharmaceutical’s strong R&D capabilities and corporate values have been widely recognized. Today, Dongkook Pharmaceutical is being reborn as a global enterprise that has proven its potential power to the whole world. Dongkook Pharmaceutical has also been well recognized in and outside Korea with the superiority of the products and the competitive product portfolio in the field of prescription medicines. Dongkook Pharmaceutical has developed and produced outstanding therapeutic products through various clinical trials. In 2006, Plant 2 acquired a rating of Grade A, the highest grade, in the injection sector from the GMP (Good Manufacturing Practice) assessment rating system. Plant 3 followed suit in 2008, receiving a Grade A rating during the assessment rating conducted by the government; thus proving high-level GMP management. For the first time in Korea, Dongkook Pharmaceutical met the European GMP standard in the injection sector; even in the API sector, Dongkook Pharmaceutical owns products complying with the EU Guidelines of EDQM (European Directorate for the Quality of Medicines). Currently, Dongkook Pharmaceutical exports finished product and API to over 50 countries, especially on EU, Japan and other advanced countries with the strict regulations for pharmaceuticals. It seeks to grow into a global leading pharmaceutical company that is trusted and loved by all domestic and overseas customers backed by the greatest global competitiveness. No.

The name of Product

Main Ingredient

1

PAMIRAY INJECTION

Iopamidol

2

POFOL INJECTION

Propofol 10mg per 1ml

3 4 5

TEICOPLANIN INJECTION DURAKINASE INJECTION LORELIN DEPOT INJECTION

Teicoplanin Streptokinase Leuprorelin acetate

Use(Indications) X-ray contrast media for neuroradiology Induction and maintenance of General anaesthesia Skin and soft tissue infections Acute myocardial infarction Prostatic Cancer

R&D Pipeline In 1990, Dongkook Pharmaceutical focused on developing products through selection and concentration in specialized fields, succeeding in the development of Minocline Strip (Local Drug Delivery System), the periodontitis medicine and the manufacture of Pofol (Propofol preparation), the intravenous general anesthetic. These two technologies were recognized as Excellent Korean Technology (KT) by the Ministry of Science and Technology in 1995 and 1996 respectively. In 2005, the company was again lauded for the superiority in formulation technologies related to long-term sustained release of peptide medicine, and it was designated as Advanced Technology Center (ATC) by the Ministry of Knowledge Economy. Currently, the Central Research Institute’s efforts are focused on developing new products requiring creative and multidisciplinary knowledge foundation, utilizing the platform technologies of synthesis, fermentation, hydrogel, nano-emulsion, microsphere based long-acting release, and multi-particles. The development of such innovative product groups serves as a footing for expanding business areas to prescription medicine markets from over-the-counter (OTC) medicine markets and to overseas markets from domestic markets. CONTACT US • Phone : + 82-2-2191-9859 • Fax : +82-6234-0589 • E-Mail : [email protected]

· Company · CEO · Specialty · Location · Homepage

Dongkook Pharmaceutical Lee, Young Wook; Oh, Hung joo Pharmaceutical 997-8, Daechi-2dong, Gangnam-gu, Seoul, Korea http://www.dkpharm.co.kr/english

23

Pharmaceutical

Development of Medications That Are Difficult to Produce but Necessary

Green Cross Corp. Green Cross is an exemplary R&D-oriented company that leads the biotechnology industry in Korea. This is clear given what Green Cross has achieved since its foundation in 1967. GCC has pioneered in the field of biopharmaceuticals, such as vaccines, plasma-derivatives, diagnostics, recombinant proteins and therapeutic antibodies. GCC has been well known for the R&D and commercialization of ‘HepavaxTM B’, a world’s biggest selling hepatitis B vaccine, ‘HantavaxTM’, a world’s first epidemic hemorrhagic fever vaccine, and ‘SuduvaxTM’, a world’s second chicken pox vaccine. A complete flu pipeline includes seasonal flu vaccine (GCFLUTM), H1N1 vaccine, avian flu vaccine and etc. GCC is also pursuing opportunities in rare diseases developing therapies for Hunter syndrome (HunteraseTM) and Fabry disease (GC1119). With continuous investment in R&D, its portfolio now includes gene/cell therapeutics and small molecule drugs. In 2011, GCC earned $616 million in revenue recording it as 3rd largest Korean pharmaceutical company and invested $51.7 million in R&D which is one of the highest in Korea.

Products Plasma Fractions & Recombinants Starting from the nation’s first Albumin production in 1971, Green Cross currently manufactures more than 12 plasma fractions including immunoglobulin, anti-hemophilic factors, and anti-thrombin factor. Recent innovations include ‘BDD rhFVIII (GreenGeneTM F)’, a 3rd Generation of recombinant Factor VIII for hemophilia A treatment. Vaccines We succeeded to develop the world’s third Hepatitis B vaccine in 1983, the world’s first epidemic hemorrhagic fever vaccine in 1988. With the construction of Hwasun plant, a vaccine-oriented manufacturing facility, the influenza vaccine GC FluTM became the fourth in the world to obtain PQ (Pre-Qualification) approval from the WHO. ETC& OTC Medicines Green Cross has provided a broad range of ethical medicines in the field of cardiovascular disease, cerebrovascular disease, metabolic disease including diabetes, hypertensive disease. Along with poultices (one of our core OTC products), we also have provided OTC products in respiratory, dermatology and immunology.

R&D Pipeline

CONTACT US Sung-Ick Park General manager Business Development Division • Phone : +82-31-260-9358 • Fax : +82-31-260-9408 • E-Mail : [email protected] Hong-kwon Woo, Manager, Global Business Team Overseas Business • Phone : +82-31-260-9415 • Fax : +82-31-260-9491 • E-Mail : [email protected]

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Project

Indication

GCFLU™ GC1109 GC1107 GC3104A GC3106A

Seasonal flu Anthrax Tetanus, diphteria D.T.P prophylaxis Seasonal flu(Cell culture)

GreenGeneTM F

Hemophilia A

HunteraseTM

Hunter syndrome

IVIG-SN

Infections

GCPGC GC1113 GC1119 GC2107 MG4101

Neutropenia Anemia Fabry Disease Anti-thrombotics Cancer · Company · CEO · Specialty · Location · Homepage

R

NC

IND

Ph I Ph II Ph III NDA

A

M

US

US Protein US

Cell therapy

Green Cross Corp. Il-Sup, Huh Plasma Derivatives & Recombinant Proteins, Vaccines, ETC& OTC Products 303 Bojeong-dong, Giheung-gu, Yongin, Korea www.greencross.com

Pharmaceutical

Innovative Medicines to Improve the Quality of Human Life

HanAll BioPharma Co. Ltd. HanAll BioPharma is an R&D-oriented pharmaceutical company, currently listed on the Korean Stock Exchange (KOSPI). It has been developing innovative and unique small molecules and large molecules to treat major diseases for the global market. The company has proprietary programs with broad therapeutic applications including oncology, immunology, endocrinology, infectious diseases, ophthalmology, and cardiology.

R&D Pipeline Product

HL156CAN

HL143 (Hanferon™)

HL143, a single amino acid variant of native IFN-alpha-2a, is a biobetter product. By utilizing Resistein™ technology, Hanferon™ is protease resistant therefore has longer half-life and improved AUC compared to the native IFN-alpha. Recently, HanAll has completed phase II trial in HCV patients comparing its efficacy and safety against Pegasys(R) within US.

HL032 (Vitatropin™)

HL032 (Vitatropin™), an orally available human growth hormone which would be the first. By using Resistein™ technology, HL032 possess greater protease resistant characteristic with significantly higher bioavailability compared to the native human growth hormone after oral administration. HanAll has completed phase I trial in Korea comparing its PK profile against Genotropin(R).

HL161 (Novel Target mAb)

A fully human monoclonal antibody targeting the Fc Neonatal Receptor (FcRn) for the treatment of autoimmune diseases was caused by IgG autoantibodies. FcRn plays an essential role in IgG homeostasis by regulating a salvage pathway that prevents lysosomal degradation of IgG, thus contributing to a long half-life in the circulation. While FcRn-mediated half-life extension is beneficial for IgG antibody responses against pathogens, it also prolongs the serum half-life of IgG autoantibodies and thus promotes tissue damage in autoimmune diseases. By blocking FcRn, HL161 can effectively reduce overall IgG concentration similar to IVIG and plasmapheresis. HL161 is currently at pre-clinical stage.

HL009

HL009 is an adenosylcobalamin liposomal gel, with three different potential mechanisms of actions for the treatment of atopic dermatitis. HL009 can bind to nitric oxide (NO) which causes dermatitis; also it can inhibit inducible nitric oxide synthase (iNOS) to further reduce NO levels. From an immunology perspective, HL009 can activate T regulatory cells which excrete IL-10 and TGF-beta suppressing immune response. HanAll has completed phase II trial in Korea and currently conducting phase II trial in US.

CONTACT US Soonim Lee, Director • Phone : +82-2-2204-1753 • E-mail : [email protected]

Information HL156CAN is a new chemical entity which activates AMP-activated kinase (AMPK) and inhibits Epithelial-to-Mesenchymal Transition (EMT). The activated AMPK inhibits mTOR thereby produce anti-proliferation effect and prevents protein synthesis which leads to autophagy and apoptosis in cancer cells. Moreover, HL156CAN selectively targets cancer stem cells and inhibits proliferation as well as prevention of the EMT which ultimately results in anti-metastatic effect. HL156CAN is currently at pre-clinical stage.

US BRANCH S. T. Oh, Director • Phone : +1-301-738-3980 • E-mail : [email protected] HPI. Inc. 9605 Medical Center Drive, Suite #290 Rockville, MD, 20850

· Company · CEO · Specialty · Location · Homepage

HanAll BioPharma Co. Ltd. Dr. Sungwuk Kim 1) Oncology & Fibrotic Disease 3) Infectious Disease 4) Immunology 5) Endocrinology 11-10 Sincheon-dong, Songpa-gu, Seoul, Korea www.hanallbiopharma.com

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Pharmaceutical

The Health Innovator

HANDOK Pharmaceuticals Co., LTD HANDOK founded in 1954, has been dedicated to developing and providing innovative pharmaceutical products including prescription drugs and OTC drugs, initially through technology collaboration with Hoechst of Germany in 1957, and later by establishing joint venture with Hoechst of Germany in 1964. Since the company’s initial public offering in 1976, HANDOK, as a joint venture, has acquired advanced technologies from prominent multinational pharmaceutical companies, and had contributed to bring foreign capitals into Korea. HANDOK is one of the most successful and oldest joint venture in Korea, and has striven to become one of the most outstanding pharmaceutical companies in 21st century through the solid partnership with Sanofi-Aventis. It is HANDOK’s values and mission to become a company that makes the highest quality pharmaceutical product that people can trust and where the talented people wish to work on their dream with passion. HANDOK strives to innovate in management by hiring the talented people who fit the company slogan ‘The Health Innovator’, and placing them in right places. HANDOK is also committed to the highest standards of ethics and integrity and to the transparency in management. HANDOK gives priority to the integrity over the size of the company and will continuously strive to become a respected, leading pharmaceutical company not just in Korea but also in the world that improves the people’s health and contributes to the development of country.

Main Products Amaryl M(Glimepiride + Metformin HCl) Amaryl M

- is the first fixed dose combination of glimepiride and metformin HCl in Korea. - is the combination with Sufonylurea + Metformin recommended by global guideline. - provides glycemic control with favorable safety profile. - significantly reduces HbA1c compared to metformin. - is superior to Metformin in FPG reduction. - allowed more patients to achieve glycemic target than Metformin. - has been registered by 57 countries. Amaryl Mex(Glimepiride + Metformin HCl)

Amaryl Mex

CONTACT US SoHyun Kwon Head of Licensing & Business Development • E-mail : [email protected]

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- is the first patented sustained-release fixed dose combination of glimepiride and metformin HCl. (Winner of Korea New Drug Award, 2009) - was applied by DRM technology (Dual Release Micro-coating Technology). - one a day can improve patients’ compliance. - has been registered by 13 countries.

· Company · CEO · Specialty · Location · Homepage

HANDOK Pharmaceuticals Co., LTD Kim YoungJin Pharmaceutical product(ETC, OTC), Medical devices 132, Teheran street, Gangnamgu, SEOUL, 135-923 www.handok.co.kr

Pharmaceutical

Thinking of the Human Health and the Future

HANLIM PHARM. CO., LTD.

With the corporate mission of protecting the precious human life from various forms of diseases, HANLIM has consistently endeavored to improve the health standards of people, and we have grown to become one of the leading companies in Korea. In 1993, the future-oriented GMP factory was completed together with the founding of the central research center. As a part of the long-term investment scheme of the company, we continue to make a great investment in accumulating advanced technologies and reorganizing manufacturing facilities lately to enhance the health of mankind as a leading pharmaceutical company.

Products [1] DAGES CAP: Digestives (Pepsin 25mg, Papain 50mg, Diastase 15mg, Cellulase 15mg, Pancreatin 50mg, Pancrelipase 13mg, UDCA 25mg) DAGES

LODIEN

HYALURON

NASATIVE

- Insufficiency of gastric, enteric and pancreatic secretion - Anorexia, meteorism, flatulence, steatorrhea, fermentative, dyspepsia with intestinal irregularity - Dyspepsia in cholecystectomized patient - Superalimentation during convalescence and fattening diets - Insufficiency of biliary secretion - Cholelithiasis, cholecystitis, cholangitis, jaundice [2] LODIEN TAB: Antihypertensives (s-Amlodipine Nicotinate 2.5mg/5mg) - Hypertension - Myocardiac ischemia due to stable obstruction of coronary artery (stable angina) or vasospasm and vasoconstriction of coronary artery system (unstable angina) [3] HYALURON EYE DROP: Epithelial protector of cornea & conjunctiva (Hyaluronate Na.1mg/mL) - Disturbances of corneal and conjunctival epithelium induced by followings; • endogenous disease (Sjogren’s syndrome, Stevens-Johnson’s syndrome and dry eye syndrome) • exogenic factor (surgical procedure, medicine, trauma, wearing of contact lens) [4] NASATIVE NASAL SPRAY: Corticosteroid for rhinitis (Mometasone furoate 0.5mg/mL) - Nasal symptoms of allergic rhinitis (Prophylaxis & Treatment) - Nasal polyps, acute rhinosinusitis without severe bacterial infection

R&D Pipeline Category Incrementally modified drugs New drugs

Project

Indication

Development stage

HL-CER HL-SAS Lodivixx Entelon HL-217 PM-014

osteoarthritis hypertension hypertension osteoarthritis AMD COPD, asthma

phase I phase I phase I phase III preclinical preclinical

CONTACT US SUNG DAE, KIM Manager / Overseas trade • Phone : +82-2-3489-6127 • E-Mail : [email protected]

· Company · CEO · Specialty · Location · Homepage

HANLIM PHARM. CO., LTD. JAE YOON, KIM R&D and manufacturing of API/BPIs, pharmaceutical product 1656-10, Seocho-Dong, Seocho-Gu, Seoul, Korea http://www.hanlim.com

27

Pharmaceutical

R&D Driven Pioneer for Innovation in Life Sciences

Hanmi Pharmaceutical. Co., Ltd.

Established in 1973 in Korea, Hanmi Pharmaceuticals now is one of the top 5 pharmaceutical companies in terms of revenue and the most R&D focused company in Korea with the highest R&D investment for several years. Hanmi has been successful for a few decades with high flexibility, continuously changing its market/development strategy from first generics to IMD &FDC (Incrementally Modified Drug and Fixed Dose Combination) to new drug development including innovative small molecules and biologics. During the period of significant changes, Hanmi made multiple strategic collaboration relationships with multinational companies and biotech companies. As the only Asian company with significant presence both in Korea and China, as the most R&D focused company with number of clinical stage projects with competitiveness, and as the company with open innovation based on multiple development/marketing collaborations, Hanmi is trying to develop and provide differentiated treatment options to patients suffering from various disease.

R&D Pipeline Esomezol Cap.

Amosartan Tab

Oncology Pipeline (as of Aug. 2012) Pipelines

Characteristics

Oraxol Oratecan HM781-36B KX-01 HM61713

Paclitaxel +HM30181A Irinotecan + HM30181A Orally active pan-Her inhibitor Src tyrosine kinase and tubulin polymerization inhibitor EGFR mutant selective inhibitor

Development Stage Phase II Licensed out to Kinex (US) Phase I Licensed out to Kinex (US) Phase I Phase II Phase I

LAPSCOVERY(Long-acting Protein/Peptide Discovery Technology) Pipeline (as of Aug. 2012) Candidates CONTACT US Licensing Out Christine Lee Assistant Manager of Global Business Development • Phone : +82-2-410-8761 • E-mail : [email protected] Licensing In Si-Young Jung Senior Manager of In-Licensing • Phone : +82-2-410-9292 • E-mail : [email protected] Export (Finished Products/APIs/CMO Business) Sangjae Lee Senior Manager of Export Business • Phone : +82-2-410-9078 • E-mail : [email protected] Information Management Kyoung Woo Lee Licensing Information Manager • Phone : +82-2-410-9291 • E-mail : [email protected]

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Characteristics

LAPS-Exendin (HM11260C) LAPS-hGH (HM10560A) LAPS-GCSF (HM10460A) LAPS-EPO (HM10760A) LAPS-IFNα (HM10660A) LAPS-Insulin (HM12460A)

Long-acting Exendin-4 analog Long-acting hGH Long-acting G-CSF analog Long-acting EPO Long-acting IFNα Long-acting Insulin

Development Stage Phase II (EU/US) Phase II (KR/EU) Phase I (KR/US) Phase I (KR/US) Phase I (EU) Preclinical

Fixed-dose Combination Pipeline (as of Aug.2012) Candidates Amosartan® HCP0703 HCP0912 HCP1102

Characteristics

Development Stage

Amlodipine / Losartan Pseudoephedrine / Levocetirizine Irbesartan / Atorvastatin Montelukast / Levocetirizine

Clinical study in ex-Korean territories Phase III Phase III Phase II, Phase III

HCP0613

Mosapride / Bacillus subtilis / Streptococcas feacium

Phase II

HCP1103 HCP1104 HCP0910

Ambroxol / Levodropropizine Aceclofenac / Eperisone Fluticason propionate / Salmeterol

Phase I Phase I Phase I

· Company · CEO · Specialty · Location · Homepage

Hanmi Pharmaceutical. Co., Ltd. Gwan-Sun Lee R&D based pharmaceutical products 14, Wiryeseong-daero, Songpa-gu, Seoul, 138-724, Korea www.hanmipharm.com

Pharmaceutical

The Company Which Has Dream of Healthy Society

Hyundai Pharmaceutical Co., Ltd.

With the long history since 1965, Hyundai Pharmaceutical Group (here after HDP) has been growing up for the best R&D pharmaceutical company in Korea and now heading to the world beyond Asia. HDP is committed to creating the best value for mankind through its innovative product development, humanistic management and social responsibilities. Through relentless pursuit of innovative effort, we have been given for several renown awards such as Best Enterprise by Korean Management Association in 1984, the Best Productivity Company among all listed companies in Korea in 1997, the President Award in National Safe and Quality Management in 2005 and 2009 and lately selected as the Advanced technology center (ATC) and innovative pharmaceutical company in 2012 by Korean government. With these recognitions, as well as our strengths in manufacturing, qualified human resources and capabilities to develop innovative pharmaceutical products, HDP has demonstrated and is now fully ready to go beyond Asian border ourselves and with our esteemed global partners.

Products Therapeutic Class Cardiovascular disease

Respiratory

Central nervous system

Women’s health Hemostatics Ophthalmologicals

Product name

Composition

SYSCOR ER ZESTRIL TAB TENORMIN/TENORETIC TAREG/CO-TAREG LEVOTUSS SYR/TAB SURFOLASE CAP ALEGYSAL DRY TAB ACTIC ORAL TAB TAMIRINE TAB PAXETIL TAB/CR TAB MIRAP TAB NORLEVO 1 TAB ELLAONE TAB GYNOFLOR VAG TAB TACHOCOMB TACHOSIL OCUVITE

nisoldipine anhydrous lisinopril atenolol/atenolol&chlorthalidone valsartan/valsartan and HCTZ levodropropizine acebrophylline pemirolast potassium fentanyl citrate galantamine hydrobromide paroxetine HCl pramipexole dihydrocholoride levonorgestrel ulipristal acetate estriol, lactobacillus aprotinin, collagen, fibrinogen, thrombin collagen, fibrinogen, thrombin ascorbic acid, beta-carotene, etc.

Indication Hypertension Coronary Heart Disease Hypertension Hypertension Acute and Chronic Bronchitis Acute and Chronic Bronchitis Allergy Breakthrough cancer pain Anti-Dementia Antidepressant Anti-Parkinson Emergency Contraceptive Emergency Contraceptive Vaginal Infection Hemorrhage during surgery Hemorrhage during surgery Supplement (OTC)

Company Bayer Astrazeneca Novartis Dompe Poli MTPC Teva HDP

HRA Takeda Bausch &Lomb

R&D Pipeline Criteria NCE

IMD

Products

Indication

Type

HOB 046 HOB 047 HOB 050 HOB 003 HOB 064 HOB 049 HOB 048 HOB 051 BPS 005 HOB 058 SURFOLASE CR LEVOTUSS CR

Type 2 Diabetes Type 2 Diabetes GI Chronic Renal Insufficiency Obesity Osteoporosis Cough Suppressant Bronchitis CNS Alopecia Bronchitis, Asthma Bronchitis

GPR119 11 beta HSDI Biotic Anti-oxidant Natural compound Osteoclast Inhibitor Peripheral antitussive Muco-active Natural compound Vasodilator/Androgen receptor Phosphodiesterase inhibitor Non-opioid antitussive

DS

PC Ph I Ph II Ph III NDA

CONTACT US Edward Kim Business Development Team Manager • Phone : +82-2-2600-3848 • E-Mail : [email protected]

· Company · CEO · Specialty · Location · Homepage

Hyundai Pharmaceutical Co., Ltd. Chang Hyun, Yoon Research and Development of new medicine and incrementally modified drug(IMD) Hyundai Pharm Bldg, Bongeunsa Street 135, Gangnam-Gu, Seoul, Korea http://www.hyundaipharm.co.kr

29

Pharmaceutical

Excellence and Contribution to the Health and Happiness of Mankind

ILDONG PHARMACEUTICAL CO.,LTD. ILDONG Pharmaceutical was founded in 1941 based on the ambition to be the protector of the health of people. The finished product manufacturing plant and pharmaceutical raw material plant strive to achieve zero defect manufacturing through advanced production facilities, strict compliance with GMP regulation and extensive quality control. We export finished drug and APIs to over 20 countries, and are actively involved in new drug development and joint ventures overseas.

Products We are ranked among the top in the domestic OTC market backed by our power brands Biovita which is Korea’s first lactobacillus probiotic product and Aronamin which occupies indisputable No.1 position in the Korean multivitamin complex market. These two powerful OTC products have been exported to around world. We are also reliable provider of ETC drug to domestic and overseas market. Especially, we have dedicated anticancer plant and cephalosporin plant approved by KFDA and these plants are expected to be approved by Japanese PMDA early 2013.

Taxozen Inj

Anti-cancer plant Lyophilized injection Liquid injection Tablet Capsule

Cephalosporin plant 10,000Vials/Cycle 6,000Vials/Hour 240,000Tablets/Day 320,000Capsules/Day

Lyophilized injection Liquid injection Tablet Capsule Dry syrup

Biovita

60,000Vials/Cycle 30,000Vials/Cycle 18,000Vials/Hour 500,000Tablets/Day 300,000Capsules/Day 600kg/Day

We provide outstanding quality synthetic and probiotic raw material manufactured in our BGMP-certified plant to domestic and foreign pharmaceutical companies, and seek to expand the overseas market based on advanced manufacturing techniques for pharmaceutical raw materials.

R&D Pipelines ILDONG Research Laboratories concentrate on new drug development, dosage form research and pharmaceutical raw material development, enriched with excellent researchers and latest research facilities. - Intractable infection suppressants (IDP-73152) (Tasked by Ministry of Knowledge Economy) - Targeted anti-cancer drugs (Tasked by Ministry of Education, Science and Technology) - Metastasis inhibitor - General-purpose antiviral agents (Regional industrial technology development program) CONTACT US Eric Kim • Phone : +82-2-526-3266 • E-mail : [email protected]

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· Company · CEO · Specialty · Location · Homepage

- Dementia treatment - Obesity-suppressing agents - Anti-diabetic drugs (Protein pharmaceuticals) - Therapeutic probiotics - Incrementally modified drugs

ILDONG PHARMACEUTICAL CO.,LTD. Lee, Jung-chi Antineoplastic Agents, Probiotics, Vitamins, etc. 2, Baumoe-ro, 27-gil, Seocho-gu, Seoul 137-733, Korea www.ildong.com

Pharmaceutical

Respect Humanity, Promote Human’s Health, Improve Welfare

IL-YANG PHARMACEUTICAL CO., LTD. Il-Yang will exert its efforts towards improving the national health and welfare through continuous research and efforts for the development of the most advanced medicines until all diseases in this land will be treated. Il-Yang Pharmaceutical Co. has tried its utmost to manufacture superior medicines for the last half a century. Since it took the first step to supply medicines in Korea, a barren land for the medical industry in 1946, IlYang has been advancing into a top-ranking pharmaceutical company in the world with developing on GI, Hematology, Vaccine, Virology area as well as vaccine plant established in April 2011 which has production capacity of 60 mil. doses per year. On the basis of the most advanced medical practice and pharmaceutical dispensing and a solid business footing in Korean market, Il-Yang has exported a variety of pharmaceuticals to approximately 30 countries in the world including USA and Europe, and has opened an era of overseas branch production by establishing YANGZHOU IL-YANG PHARM. CO., LTD. and TONGHUA IL-YANG HEALTH PRODUCTS CO., LTD. for manufacturing end-pharmaceuticals in China

Products

Supect

1. Supect (API: Radotinib) 1) 2nd generation Bcr-Abl tyrosine kinase inhibitor (TKI) for the treatment of Philadelphia chromosome positive (Ph(+)) CML. 2) Indication: Ph(+) chronic myeloid leukemia (CML) in chronic phase (CP) or accelerated phase (AP). 3) Development stage: - CML-CP NDA approved in Korea by KFDA in 5th JAN, 2012. - Phase III for CML-CP has initiated in Korea, Thailand, India, and Philippines. 4) Key features - No serious side effect - Early efficacy signals higher than initial MCyR response at 6 month 2. Noltec (API: Ilaprazole) 1) 14th New Drug developed in Korea 2) Noltec is a Proton Pump Inhibitor that controls the secretion of gastric acid for the treatment of GU, DU, GERD/EE, and NERD 3) Greater effect on Severe GERD patients, low reoccurrence, no symptoms of night time heartburn, and low DDI 3. Anti-Viral agent

Noltec

IY 5741 has been announced at American Society for Virology on 22 July, 2012 that it is 20~30 times potent than Tamiflu

R&D Pipeline Compound Ilaprazole

Radotinib Virology

Application

Country

GU / DU

Korea, China

EE / GERD

Korea USA

NERD CML-CP CML-CP Virology

Korea Multi national Multi national IY5741 Vaccine

Ph I

Ph II

Ph III

NDA

Marketed

ongoing ongoing

CONTACT US Sun Park. Ph. D. General Manager / Licensing Team • Phone : +82-2-570-3787 • Fax : +82-2-570-3890 • E-Mail : [email protected]

· Company · CEO · Specialty · Location · Homepage

IL-YANG PHARMACEUTICAL CO., LTD. DONG YEON, KIM Urology, GI, Dermatology, Oncology, Vaccine, Biopharmaceutical IL-Yang Bldg. 544-5 Dogok-dong, Gangnam-gu, Seoul, Korea www.ilyang.co.kr

31

Pharmaceutical

Accumulation of High-value Core Technologies in Biotechnology to Develop Future Products

ISU ABXIS 1) ISU ABXIS’ Innovative Model “Shift from orphan drug biosimilar company to a global biotechnology company” 2) Specialized sector: Therapeutic biological drug development (Including enzyme pharmaceutical drug) A. Experience on the full process of development from preclinical phase to marketing phase B. Focus on the development of novel anticancer antibody drug and blockbuster biosimilar drug C. Specialized technology - Antibody screening technology - Efficacy verification - Therapeutic antibody production - Clinical Development - GMP facility approved by 6 different countries including Korea 3) Differentiated business model A. Early phase licensing out of novel drug B. Expansion of biosimilar drug ⓐ Acceleration of approval for the current developing pipeline: Abcertin®, Cloninab®, ISU303  ⓑ Development for the next generation blockbuster biosimilar drug: ISU103 (Brest cancer drug), ISU202 (Rheumatoid arthritis drug) C. Business focus on the BRIC market

Products Clotinab® (Antiplatelet antibody, Abciximab) Product profile A. The first biosimilar of Reopro® of Eli Lilly B. GPIIb/IIIa receptor antagonists/ anti-thrombotics C. Binds to the glycoprotein (GP) IIb/IIIa receptor of human platelets and inhibits platelet aggregation D. Indication: Adjunct to PCI (Percutaneous coronary interventions)

R&D Pipeline Product

Indication

ClotinabⓇ

Adjunct to PCI (Percutaneous Coronary Interventions)

ISU302 ISU303 ISU103 ISU202 ISU201 ISU104 ISU105

Type of Product

Gaucher disease Fabry disease Her2 positive cancer RA and inflammatory diseases Inflammation Oncology Oncology

Status

Launch

Biosimilar(ReoProⓇ)

Antibody

Marketed

2007

Biosimilar(CerezymeⓇ) Biosimilar(FabrazymeⓇ) Biosimilar(HerceptinⓇ) Biosimilar(HumiraⓇ) Novel drug Novel drug Novel drug

Enzyme Enzyme Antibody Antibody Antibody Antibody Antibody

NDA ready Phase III Phase II Preclinical development Preclinical development IND ready Lead development Lead development

2012 2013 2016 2018 -

CONTACT US Yunseung Chung, Senior Manager Business Development • Phone : +82-2-390-4921 • Fax: : +82-2-390-4999 • E-Mail : [email protected]

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· Company · CEO · Specialty · Location · Homepage

ISU ABXIS Changhoon Choi Biological pharmaceutics development based on the technology platform for monoclonal antibody and animal cell culture Yonsei University Medical Center, 134, Seodaemungu, Seoul, Korea www.abxis.com

Pharmaceutical

Jump to the World

JW Pharmaceutical Corp.

JW Group provides pharmaceuticals vital for maintaining the lives of patients such as anti-cancer drugs and antibiotics, and has developed into a leading pharmaceutical company and global manufacturer of I.V. solutions. Furthermore, JW Group is exploring the new markets of OTC/healthcare and development and supply of diagnostics and medical equipment. JW Group, whose products enhance the healthy living of its customers, approaches them as a friendly corporation. JW Group is being reborn as a total healthcare group to fulfill the precious dreams and hopes of humankind. JW Group has continuously carried out research on disease based on its long-time experience and knowhow in the field of pharmaceuticals, and continues to accumulate meaningful research outcomes. In addition, by establishing the Drug Discovery Center, CMC Research Center, JW Theriac and C&C Research Labs and conducting joint research projects with leading global research institutions, it has built a global R&D network for the development of new innovative drugs. JW Group’s mission to cure diseases and develop groundbreaking technologies goes on today.

Major Export Products Type

Product Group

Finished Product

1. Carbapenem Antibiotics 2. Amino Acid Solutions 3. General I.V. Solutions & Other Sterile Solutions 4. Anticancer Agents 5. Antimicrobial & Antifungal Agents 6. Gastrointestinal Agents 7. Topical 8. Multivitamins 9. Agents for Antibiotics 10. Miscellaneous

API (Active Pharmaceutical Ingredient)

1. Carbapenem Antibiotics: Imipenem/Cilastatin, Meropenem 2. Anti-fungals: Ketoconazole, Itraconazole, Fluconazole 3. Chiral Products for Custom Synthesis & Specialty Amino Acid 4. Miscellaneous

R&D Pipeline LivasartanTM ®

Contact Information Business Development (Licensing) • Phone : +82-2-840-6710 • E-Mail : [email protected] Global Business (Export) • Phone : +82-2-840-6162 • E-Mail : [email protected] Corporate Research Planning • Phone : +82-2-840-6943 • E-Mail : r [email protected]

FESNS Nano oxaliplatin UR1102 JWP1201 CWP231 CWP232291 CreaVax RA® CreaVax PC® CreaVax BC® Preclinical PhaseI

JW is focusing on developing Biologics as well as Small molecules in the areas of oncology, endocrinology and immunology by employing its novel platforms Small molecule NCEs Biologics

CWP241 sTU199 CreaVax HCC® Phase II

CWP0403 LivasartanTM CreaVax RCC® Phase III

Combiflex® Dia-MTM Actemra® Registration

▶ Pipeline represents progress of R&D programs since 2010 ▶ Included are 12 NMEs plus 3 additional indications, 1 administration route change, and 1 advanced generic development · Company · President · Specialty · Location · Homepage

JW Pharmaceutical Corp. Kyung Ha Lee I.V- solutions, antibiotic, cardiovascular, gastrointestinal, nephrology/antianaemic, anticancer and neuropsychiatryincrementally modified drug (IMD) 2477 Nambusunhwan-ro, Seocho-gu, Seoul, Korea www.jw-pharma.co.kr

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Pharmaceutical

Creating the Value of Health and Beauty

Kolmar Korea Co., Ltd.

It has been 22 years since Kolmar Korea began to dream of beauty and health in 1990. Beginning as an Original Equipment Manufacturer (OEM), Kolmar Korea introduced and established the new business model called the ODM network, and made a ceaseless effort to develop the high-tech-field of its own pharmaceutical and functional heath food manufacturing. In addition to the technical power and quality, the leadership of Kolmar Korea is making progress in the direction toward contributing to establishment of core values, with which our business partners and end users of the products may find out the advanced beauty and healthy life.

R&D Kolmar Korea reinvests more than 6% of net sales into its research and development, grafting 100 years’ worth of R&D know-how into research and development, and leading the latest trend by developing world-class pharmaceuticals, health functional foods and cosmetics. Kolmar Korea has been approved not only in domestic market but in international market for its great and predominant technology.

Global Kolmar Kolmar Korea has its roots in the world-wide Kolmar Group. The Kolmar Group based on Kolmar Americas Inc., which is the parent organization of Kolmar Group and was established in Milwaukee, Wisconsin, in 1921, has the world-wide network including Kolmar Japan, Korea, and China, showing off the vast scale in the world. In the global network of Kolmar equipped with 100-year-old R&D know-how, the continuous information exchanges are carried out through the regular symposium and academic activities by affiliated research group members, so that latest data concerning marketing may be shared as well as technologies. Also Kolmar Korea takes the initiative in the development history of world-wide pharmaceutical and cosmetic history.

Products Kolmar Korea has a cutting-edge technology called ‘LIDCAPS’ that enables liquids to fill into hard-shell capsules. The representative products taking advantage of the technology are Lidsen cap.(naproxen), cough-zero cap., Dentilid cap.(Titrated extract of the unsaponifiable fraction of Zea mays L.), which have been approved by KFDA first in Korea. Besides, Kolmar Korea’s product line-up covers virtually all the therapeutic areas such as cardiovascular system (Amlodapine tab.), dermatologicals (Mitra cap.), genito-urinary system (Taminal cap.), respiratory system (Pellium syrup.), alimentary treat (Panto-K tab.) and metabolism (Glimepirid tab.), etc.

R&D Pipeline Category New Herbal Drug

CONTACT US Jin-Young Kim Executive Director • Phone : +882-2-3485-0470 • Fax : +82-2-515-1532 • E-mail : [email protected] Moon-Su Pyo Director /Global Business Dept. • Phone : +882-2-3485-0497 • Fax : +82-2-515-1532 • E-mail : [email protected]

34

Small Molecules Combination Product

Candidate

Indication

KKM0801

GI Ulcer

Development stage Phase I

KKM1011

Hypertension

Phase II

KKM1012

Diabetes

Phase II

KKM1102

Infections

Preclinical

KKM0805

Osteoporosis

Phase I

KKM0902

Osteoporosis

Phase I

KKM1201

Hyperlipidemia

Phase II

KKM1202

Benign Prostatic Hyperplasia

Phase III

· Company · CEO · Specialty · Location · Homepage

Kolmar Korea Co., Ltd. Hong-Koo CHO Pharmaceuticals/Cosmetics/Health Functional Foods CNI BD 1596-3 Seocho-Dong Seocho-Gu Seoul Korea http://www.kolmar.co.kr

Pharmaceutical

Otsuka-people Creating New Products for Better Health Worldwide

Korea Otsuka Pharmaceutical Co.,Ltd. Korea Otsuka Pharmaceutical is a branch of Otsuka Group International, which was established in Korea in 1982. Korea Otsuka has set as its mission to contribute to Korea’s healthcare industry, in line with which its main products include “Abilify”, an antipsychotic medication, “Mucosta”, a medicine for gastritis and gastric ulcer and “Pletaal”, an antiplatelet agent. Otsuka Pharmaceutical Group plans to make 1 KRW 1 trillion to the nation by 2013 upon MOU for R&D cooperation made with the Ministry of Health and Welfare in 2009 in order to contribute to the domestic development of new medicines and the advancement of local R&D infrastructure. The total investment that Otsuka Pharmaceutical Group has made from 2009 to 2011 surpasses 50.9 billion won. Korea Otsuka Pharmaceutical was started with the construction of the Hyangnam Plant back in September 1989. The plant acquired KGMP (Korea Good Manufacturing Practice) and BGMP (Bulk Good Manufacturing Practice) recognition in December 1990 and December 1999, respectively, and, as a result, the plant was recognized for being suitable as a material medicine manufacturing facility from the FDA in July 2000.

Mucosta Tab.

Abilify Tab.

Korea Otsuka Pharmaceutical has a world-class level of technological power, built upon the systematization of manufacturing facilities and the advancements made in its business processes and synthesis technologies. It currently exports the materials/finished medicines produced with its competitive, technical strengths to Japan and 10 countries within Southeast Asia. With other multinational pharmaceutical companies tending to look to close down their factories, Korea Otsuka Pharmaceutical is bucking this trends, with plans to expand its exports and diversify its exporting regions by establishing a firmer foothold, with a production base that covers Asia and Middle East, including its synthesis plant for Rebamipide, which was completed in October 2003. The company is currently planning to build a manufacturing line that is possible to respond to EU GMP and cGMP in order to expand the items it exports and the regions it exports to.

Business Korea Otsuka Pharmaceutical has production facilities based in Korea, contributing to its exports to 10 countries, including Japan, China, Philippine and Indonesia. In fact, the company has produced a medicine for global clinical trials, which requires a high-level of technology, and successfully exported this to Japan in 2011.

Pletaal Tab.

Korea Otsuka Pharmaceutical’s differentiated clinical development, exports and its role: 1) Korea Otsuka Pharmaceutical has amplified the advantages of clinical development environment of KoreaChina-Japan, improved the efficiency of new medication development and contributed to better healthcare service for Asian by developing a cure for endemic disease in relevant country 2) A development center for anti tuberculosis drug and diagnosis/medicine-taking model 3) Korea Otsuka Pharmaceutical has developed medications best suited for the country (obtained approval for pharmaceutically modified drug, Platelet SR drug and for the world’s first approval for Abilify tablet being efficacious for Indication of child’s diseases through clinical trials with in the country)

CONTACT US R&D/Export/Product Hong Inpyo Clinical Development Team • Phone : +82-2-3287-9200 Others Jung Hyejin Planning Team • Phone : +82-2-3287-9146

4) As a Korean company exporting its products to overseas, Korea Otsuka Pharmaceutical has made a great contribution to export in the last three years (20.6 billion won in 2009, 25 billion won in 2010 and 28.4 billion won in 2011).

· Company · CEO · Specialty · Location · Homepage

Korea Otsuka Pharmaceutical Co.,Ltd. Moon, Sung-ho The manufacture, sale, import and export of pharmaceuticals and pharmaceutical products 770-9 Yeoksam-dong, Gangnam-gu, Seoul, Korea www.otsuka.co.kr

35

Pharmaceutical

KUP Is a Global Gharmaceutical Company All around World

Korea United Pharm. Inc. Exporting 200 different drugs to 30 different countries through global marketing with infrastructure factories in USA, Vietnam, and agents in other countries. KUP ranked among Forbes’ ‘Asia’s 200 Best Under A Billion’ two years in a row Korea United Pharm. is one and only pharmaceutical company in Korea picked by the Forbes magazine as one of the ‘Asia’s 200 Best Under A Billion’ two years in a row (2009~2010). Designated as an Advanced Technology Center

Clanza®CR Tabs.

Korea United Pharm.‘s Central Research Institute was approved as an Advanced Technology Center on July, 2004 by the Korean government. To be the Advanced Technology Center, following criteria are essential: high technology of drug manufacturing and quality excellence. Not only did KUP meet these standards, but is also accredited to have outstanding research performance on value-added raw material compounds. KUP is successful developing innovative drugs and commercializing it. We are constantly releasing new and value-added products such as anticancer drugs, hypertension drugs, and antidepressants.

Major Products Name

Indication

Phase

Classification

Clanza®CR Tabs. Clavixin®Duo Caps. Cilostan®CR Tabs.

analgesic antithrombotic antithrombotic

On Market On Market In registration

New Controlled Release Drug New Combinational Drug New Controlled Release Drug

Clavixin Duo Caps. ®

Korea United Pharm. Int’l Jsc.(Vietnam)

R&D Pipeline NME

United Douglas Pharm. Inc.(USA)

IMD

CONTACT US Executive Director Won-Tae Jung Department of Global R&D • Phone : +82-2-558-8612(Ext.201) • E-mail : [email protected] Manager Jin-Seok Jeon BD Licensing Team, Department of Global R&D • Phone : +82-2-558-8612(Ext.205) • E-mail : [email protected]

36

Formulation Study

CMC

Nonclinical

Liverstar® Inj.







Clinical

Launch

Docetaxel HS/BA Inj. Clanza® CR Tabs. Clavixin® Duo Caps. Cilostan® CR Tabs. Unigril® CR Tabs.

○ ○ ○ ○ ○

○ ○ ○ ○

○ ○ ○ ○

○ ○ ○ ○

○ ○ In registration

Gastin® CR Tabs.



Aner® CW Tabs













Levonazine® CR Tabs.









Unasc® Duo Tabs.



(NME : New Molecular Entites, IMD : Incrementally Modified Drugs)

· Company · CEO · Specialty · Location · Homepage

Korea United Pharm. Inc. Duk-Young Kang Manufacture, Marketing, & Sales Distribution of Pharmaceuticals and Other Healthcare Products 25-23, Nojanggongdan-Gil, Jeondong-Myeon, Sejong, Korea www.kup.co.kr

Pharmaceutical

Global Pharmaceutical Company Committed in Providing Better Quality of Life for People.

Kuhnil Pharmaceutical Co.,Ltd Kuhnil Pharm continues to strive to become a unique research-focused global company through development of innovative global biopharmaceuticals, DDS pharmaceuticals, and combination drug products in an effort to improve quality of life in patients.

Amocla/Amocla Duo Tab/Syr/inj

Kuhnil has adopted a unique strategy of advancing into a new and niche areas of pharmaceutical development such as development of a world’s first approval of Omacor’s new indication called IgA nephropathy as well as developing new indication in the treatment of ulcerative inflammation of the small intestine for a novel GI drug. In 2005, Kuhnil participated in the NSCLC clinical program for an innovative biopharmaceutical, TheraCIM, subsequently collaborating with Daiichi-Sankyo to initiate the phase 3 trial for gastric cancer in Korea and Japan in the 2nd half of 2012. In addition, Kuhnil has partnered with foreign CROs for the development of interferon-ß biosimilar. A subsidiary company, Penmix, specializes in penicillin formulation manufacturing. With the opening its new cGMP injectable facility, Kuhnil envisions the global CMO company reaching out abroad including Japan and EU, particularly, utilizing Kuhnil’s know-how in the areas of lyophillization process.

Products Tabaxin inj.

Antibiotics Piperacillin Inj.

Product

Content

Major Export Country

Amocla/Amocla Duo Tab/Syr/inj Tabaxin inj.

Amoxicillin Pot.clavulanate Piperacillin sodium Tazobactam

Piperacillin Inj.

Piperacillin Sodium

Pentacillin Inj.

Ampicillin Sodium Sulbactam Sodium Budesonide micronized Thiocolchicoside Amorphous aescin

Malaysia/Singapore/Vietnam * Export, 2011Y: 0.7m$ Philippine * Export, 2011Y: 0.04m$ Japan * Export, 2011Y: 8.3m$ Japan/Vietnam/Philippine * Export, 2011Y: 14.0m$

Respiratory

Pulmican Respule

Muscle relaxants

Thiosina Tablet

Pentacillin Inj.

R&D Pipeline Pulmican Respule

Area of Research Novel Drug Development

Thiosina Tablet

Bio-pharmaceuticals

Modified Formulation/ Improved Drugs

CONTACT US SeungGoo Ryu R&D Center / Team Manager • E-mail : [email protected]

Pipeline

Technology

Indication

Development Stage

KI 0401 KI 0501 KI 0801 KI 1001 KI 1002 KI 1003 KI 1007 KI 1101 KI 1103 KI 1104 KI 1105

Fermentation Antibody Recombinant therapeutic proteins

Antibiotic Stomach Cancer/Lung cancer Neurological disorders Insomnia Cancer Eating disorder Angina Musculoskeletal system disorder Genitourinary system Hair loss Sexual dysfunction

Launched Phase 2/3 Research Phase 3 Research Research Research Research Research Research Research

Improved bioavailability Extended release Extended release

 Chemosynthesis

· Company · CEO · Specialty · Location · Homepage

Kuhnil Pharmaceutical Co.,Ltd Young Joong Development, Manufacturing, and Distribution of Various Pharmaceutical Products including Oral Dosage Forms, Injectables, Inhalers, etc. OhSong B/D 27-11 Jung-Dong, Joong-Gu, Seoul, Korea, 100-120 www.kuhnil.com

37

Pharmaceutical

World’s Leading Human Healthcare Provider Delivering Health and Happiness

Kwang Dong Pharmaceutical Co., Ltd. Kwang Dong has been advancing in to a top-ranking pharmaceutical company in the world through the establishment of the most advanced factories in Pyungtaek City. We were established in 1963 and have been expanding our business operations around the world ever since. We have been enjoying an excellent reputation in technology over forty years because of the goods quality and dependability of our goods. We are one of leading pharmaceutical manufacturer in Korea having GMP factory for ETC, OTC, drink and nutrition supplement. So, we have been exporting to our pharmaceutical products (Finished products) to sell all over the world.

Products 1. Product Name: Bicalude Tablet (Bicalutamide 50mg) - Indication: Advanced prostate cancer in combination with LHRH analogue therapy or surgical castration - Visa Status Comment: Registered in Vietnam 2. Product Name: Lenara Tablet (Letrozole 2.5mg) - Indication: Breast cancer - Visa Status Comment: Under registration in Philippine and Malaysia 3. Product Name: Kwangdong Woohwang Chungsimwon Indication: Stroke, Hypertension, Palpitation, Mental anxiety, Acute. - Visa Status Comment: Registered in Japan and Vietnam 4. Product name: Sedera ODF (Sildenafil citrate 50mg) - Indication: Treatment of erectile dysfunction 5. Product Name: Cool strip ODF (Cetylpyridinium chloride 1.5mg) - Indication: Preventive treatment of pharyngitis, amygdalitis, stomatitis

R&D Pipeline Product Name

Development Phases

Indicant

Dosage Form

Development Type

KD501

Clinical test Phase II

dementia

oral

License in from Elcomscience (Kor) Self developed

KD103

Developing

dementia, Alzheimer’s disease

considering

Self developed

Metabolic disease

KD101

Pre clinical

obesity

oral

Self developed

Endocrine System

KD802

Pre clinical

short  stature

Injection

License in from Genexine (Kor) / joint research

Digestive trouble

Ramosetron ODF

IND

antinauseant medicine

oral / film

Self developed

Category Central Nervous System

CONTACT US S.D. Kim / Rae Nah • Phone : +82-2-6006-7258 +82-2-6006-7259 • E-mail : [email protected], [email protected]

38

· Company · CEO · Specialty · Location · Homepage

Kwang Dong Pharmaceutical Co., Ltd. Choi, Soo Boo Pharmaceutical business, Beverage Business 1577-4 Seocho-Dong, Seocho-Gu, Seoul Korea www.ekdp.com

Pharmaceutical

Leading Global Life Science Company

LG Life Sciences, Ltd.

The First Pioneer in Korean Pharmaceutical R&D Products LG Life Sciences is Korea’s leading biopharmaceutical company. One of LG Group affiliate, demerged from LG Chem in 2002. LGLS is leveraging its proven R&D capabilities to develop world-class products, Factive®, the only US FDA approved novel chemical drug, as well as Valtropin®, the first biosimilar approved by the EMEA and US FDA developed in Korea. LGLS is building a network of strategic alliances to extend its R&D and marketing reach.

Products

Factive®

Factive® - Fast Active, the most potent quinolone antibiotic in the world, commercialized in over 30 countries worldwide Zemiglo® - A novel dipeptidyl peptidase IV (DPP IV) inhibitor for T2DM with good efficacy and safety profiles. Approved by the KFDA in June, 2012 Eutropin® - The right choice for managing short stature recombinant human growth hormone with proven efficacy and safety since 1993 Espogen® - Human recombinant erythropoietin, safe and effective treatment for anemia of chronic renal failure Follitrope® - Recombinant FSH, used in the treatment of female infertility in controlled ovarian hyperstimulation to induce the development of multiple follicles in a medically assisted reproduction program as well as anovulation Hyruan Plus® - High molecular weight hyaluronic acid viscosupplement made by microbial fermentation for low side-effect, quality proven by EMEA and CE marking

R&D Pipeline Declage®

SR-hGH - The world’s first once-a-week human growth hormone, US NDA has been filed for adult and multinational phase III trials are finished for pediatric GHD Monoclonal Antibody Biosimilars - Enbrel, Humira and Avastin biosimilars are undergoing active development 1) Chemicals

Eutropin plus®

Therapeutic Area Infectious Metabolic CV

Zemiglo®

Others

Product

Indication

Factive

IV Formulation

LC280391, etc.

Type 2 Diabetes

Not Disclosed

Anti-obesity

PC

PI

Clinical Trial PII PIII

NDA



LC280126

Liver Embolism

LC231306

Atherothrombosis

LC350189

Gout

LD02GIFRO

Prokinetic

LD09RP

DS

○ ○ ○ ○ ○ ○

Retinitis pigmentosa



2) Biologics Euvax B®

Class

Product

Indication

Biosimilar

Espogen

Anemia of CRF (global)

Long Acting

SR-hGH

GHD (global)

Antibody Biosimilar

Enbrel

Rheumatoid Arthritis

Vaccine

Humira/Avastin Euforvac-hib

DS

PC

PI

Clinical Trial PII PIII

NDA

MKT

○ ○ ○

Rheumatoid Arthritis/Colon cancer D/T/P/HBV/M prevention

○ ○

CONTACT US Jong-heon Won, Manager Business Development Team • Phone : +82-2-6924-3233 • E-Mail : [email protected]

· Company · CEO · Specialty · Location · Homepage

LG Life Sciences, Ltd. Il-Jae Jung New chemical entity, biosimilar, Diagnositcs LG Gwanghwamun Bldg. 92, Sinmunno-2ga, Jongno-gu, Seoul, Korea www.lgls.com

39

Pharmaceutical

Toxin, Filler and Even More

Medytox

We are at the forefront of Korean biopharmaceutical industry, thanks to our excellent R&D capabilities based on our top-tier biotechnologists, and to our state-of-the-art operations and production facilities. Moreover, we are going to become a trailblazer in the field of biotechnology due to our passion and courage to embrace global challenges. Since Botulinum Toxin Type A Neuronox (Neuronox is also being sold worldwide under different brand names such as Siax, Botulift, Cunox and Meditoxin) was launched in 2006, Medytox has shown a dramatic growth. Since 2009, we have ranked No. 1 market share in Korea and reached near 40% of market share. As more diverse indications are added, it appears that our market share would further increase. Our company has successfully developed the fourth botulinum toxin biopharmaceuticals in the world. We are exporting the products to about 50 countries, including Japan, Thailand, India and Brazil. We are also expecting to be a leading global biopharmaceutical company after entering the North America and EU markets in 2016.

Main Products 1. Botulinum Toxin Type A product Medytox’s core business area is manufacturing botulinum toxin type A biopharmaceuticals, Neuronox. It is widely used not only in the cosmetic field, including facial wrinkle reduction, but also in the therapeutic field, for people with blepharospasm, cerebral palsy, etc. 2. Hyaluronic Acid Dermal Filler Medytox’s hyaluronic acid filler, Neuramis is currently being used in the field of cosmetics to smoothen deep and fixed wrinkles on skin tissue. Also, it is used as therapeutic agent for surgery and for treatment of arthritis. As a partner product, it could maximize a synergy effect along with Medytox’s core product Neuronox.

R&D Pipeline

Nueronox®

Fueled by the success of Nueronox, we plan to perform a basic study for the development of innovative bio pharmaceuticals to heal degenerative arthritis, senile ocular disease, skin disease and cancer. We have strengthened base technology in protein engineering, antibody engineering and cell biology by recruiting talented personnel. As the first achievement, we have completed basic verification studies on degenerative arthritis and senile ocular disease (MT202 and MT401). It appears that they would enter into the pre-clinical phase in 2013. We plan to keep making investments with a long-term vision to be a global biopharmaceutical leader through development of innovative drugs.

CONTACT US Ochang Headquarters/Microbial Toxin R&D center • Phone : +82-70-8666-7520 • Fax : +82-43-217-1557 • E-Mail : [email protected] Seoul Office • Phone : +82-2-3471-8319 • Fax : +82-2-3471-8374

40

· Company · CEO · Specialty · Location · Homepage

Medytox Jung Hyun Ho Botulinum toxin products, Medical aesthetics, Bio-pharmaceuticals 641-4 Gak-ri, Ochang-eup, Cheongwon-gun, Chungbuk 363-883, Korea www.medytox.com

Pharmaceutical

For the Health Life and Fruitful Future

Samjin Pharmaceutical Co., Ltd.

Since its establishment in 1968, we, Samjin Pharm Co., Ltd. have strove our utmost efforts for producing qualitative pharmaceuticals and investing to research for the development of a new drugs with a philosophy of company that “Respect for human life”. GMP Factory The manufacture of pharmaceutical products is the most important field of pharmaceutical industry as well as research and development. The production of pharmaceutical products, which demands the utmost precision and professionalism is a standard to evaluate the level of the pharmaceutical company. The manufacturing factory supports Samjin Pharmaceuticals’ advanced technology as well. In order to maintain the precision of manufacturing the pharmaceuticals, which is sensitive to all kinds of qualification, Samjin Pharmaceutical plant has been operated with the scientific and automatized system in all manufacturing processes.

Products Samjin Pharmaceutical is a comprehensive pharmaceutical company of developing, manufacturing and marketing finished products and APIs in the worldwide market. The representative products, “GEWORIN Tablet” has been occupied significant market share in analgesic market in Korea, and Samjin Pharmaceutical has continuously developed a marketing strategy for potential increase in sales and profits with high quality generic pharmaceuticals such as anti-platelet agent “PLATLESS Tablet (Clopidogrel 75mg Tablet)” and Clopidogrel Bisulfate (crystal form 1). Samjin Clopidogrel Bisulfate (crystal form 1) has excellent physico-chemical properties for the direct compression such as narrow particle size distribution, good flowability and good bulk density.

R&D Pipeline 1. Development of Anti-HIV Agents : SJ-3366 SJ-3366(IQP-0528) is a unique and highly potent new nonnucleoside reverse transcriptase inhibitor of human immunodeficiency virus type 1(HIV-1) that also inhibits HIV-2. Also its product is a novel candidate for a vaginal topical microbicides, currently being performed with preclinical study against formulation both a gel and an intravaginal ring. 2. Development of Anticancer Agents : SJ-3902 SJ-3902 Series is a novel, highly potent and safe anticancer agent with unique mechanism of action and chemical structure suggesting the first member of new pharmacology class of tumor cell cycle interrupt on oncology field. The compound exhibits microtubule-interfering (G2/M), apoptosis, and inhibition of angiogenesis. 3. Development of anti-influenza virus The derivatives of benzimidazole and coumarin as extracts of plants were identified a potent efficacy of influenza virus A and B, low cytotoxicity. These compounds inhibit the bind to haemagglutinin and influenza viruses, also neuraminidase of viruses

CONTACT US Bum Kyu, Shin General Manager, Overseas Business Department • Phone : +82-2-3140-0673 • Fax : +82-2-392-5315 • E-Mail : [email protected]

4. Development of therapeutic agent for neurodegenerative brain disease : SJ-2249 A potential therapeutic candidate to target brain neurodegeneration by repressing chronic microglial activation and inhibition of acetylcholinesterase

· Company · CEO · Specialty · Location · Homepage

Samjin Pharmaceutical Co., Ltd. Sung Woo, Lee Manufacture, Marketing and Distribution of Pharmaceutical Products (Finished Products and APIs) 338-8, Seogyo-Dong, Mapo-Gu, Seoul, Korea www.samjinpharm.co.kr

41

Pharmaceutical

Innovative Specialty Pharmaceutical Company

Samyang Biopharmaceuticals Corporation.

Samyang Biopharmaceuticals Corporation., with is central research, center is engaged in the development and marketing of novel drug delivery systems and medical devices. Samyang Biopharmaceuticals Corporation is focusing its efforts on healthcare as its core strategic business of the 21st century. Samyang Biopharmaceuticals Corporation is developing proprietary and unique core technologies for the development of world class novel drug delivery systems.

Main Products Pharmaceuticals Category

Injection

Trans-dermal

Oral

Products

Active Ingredient

Indication

Genexol® Inj.

Paclitaxel

Anti-cancer

Genexol®-PM Inj.

Paclitaxel

Anti-cancer

Nanoxel®-M Inj.

Docetaxel

Anti-cancer

Pemed® Inj.

Pemetraxed

Anti-cancer

Zolenic® Inj.

Zoledronic Acid

Bone metasis

Emastop® Inj.

Ramosetron

Anti-emetics

Rheumastop® Plaster

Diclofenac Diethylamine

NSAIDs

Tulobuterol Patch

Tulobuterol

Bronchodilator

Fentaderm® Patch

Fentanyl

Rivastigmine Patch

Rivastigmine

Emestop® FD Tab.

Ramosetron

Severe Pain Anti-Parkinson Anti-Alzheimer Anti-emetics

Medical Devices Category

Products

Suture Implantable Mesh Wound Closure

Synthetic Absorbable Suture (PGA, PDO, PGLA, PGCL etc.) Hernia Mesh, OBGY Mesh, Dental Mesh Surgical Sealant, Hemostat

R&D Pipeline Category Injection

Business development Hee-Jeong Bae Manager, Business development • Phone : +82-2-740-7262 • E-Mail : [email protected]

42

Products

Development Status

Polymeric Micelle

Genexol®-PM Nanoxel®-M

Marketed Registration

Polymeric Nano-Particle

Docetaxel-PNP Voriconazole-PNP hGH-PMP SR Capsaicin Fentaderm® Rivastigmine Celecoxib

Clinical (Phase I) Clinical (Phase I) Non-clinical Clinical (Phase II) Registration BE study Non-clinical

Polymeric Micro-Particle

CONTACT US Oversea Sales Jae-Wook Joo Team Leader, Sales Team • Phone : +82-2-740-7163 • E-Mail : [email protected]

Technology Description

Trans-dermal

TDS (Transdermal Drug Delivery System)

Oral

BA enhancing

· Company · CEO · Specialty · Head Office · Homepage

Samyang Biopharmaceuticals Corporation. Cheol-Ho Kwak Oncology, Drug Delivery System Technology 263 Yeonji-dong, Jongno-gu Seoul 110-725 www.samyangbiopharm.com

Pharmaceutical

Oncology API and Injections, GMP Manufacturing

Samyang Genexbio Corporation Samyang Genexbio has solidified its reputation as a quality manufacturer with Worldwide GMP system and facility. Soon to be united with Samyang Biopharmaceuticals within Samyang Group, the product portfolio is now more complete than ever. Samyang now provides its customers an excellent selection of active ingredients and finished products in the forms of injections, patches, and capsules. - Specialty Active Pharmaceutical Ingredients [APls] - Specialty Injectables [Finished form] - Contract Manufacturing Service [Liquid & Lyophilized Injectables] - Strength in Plant Cell Culture, Fermentation, and Purification - Strong investment into Pharmaceutical Research & Development - Full cGMP Compliance

GMP Certifications from Foreign Health Authorities Hungary(2004) EU/Germany(2004,2008,2011) Iran(2009) Japan(2010) EU/Germany(2011) Iran(2009) EU/Germany (2010, 2012) Japan(2010) Australia(2011)

Paclitaxel API Docetaxel API Oncology injectables (Sterile product) Patch product

Product Pipeline Anti-cancer API Antibiotic Immunosuppressant Finished Product (Oncology) Finished Product (Other injectable) Finished Product (Patches) Finished Product (Capsule) Contract Manufacturing

Paclitaxel, Docetaxel, Cabazitaxel Epothilone, Ixabepilone Everolimus, Temsirolimus (under development) Vancomycin-HCl Tacrolimus, Sirolimus Paclitaxel, Docetaxel, Oxaliplatin Gemcitabine, Ramosetron Zoledronate (under development) Iron-sucrose OctreotideLAR, ExenatideLAR Diclofenac, Tulobuterol, Rivastigmine Nicotine, Capsaicin, Fentanyl Tacrolimus Oncology injectables (Solution/Lyophilized) Patch products

Products and Services Samyang Genexbio offers both active pharmaceutical ingredients and finished products as well as contract manufacturing service. CONTACT US Mr. Dwight You, Senior Manager • Phone : +82-2-740-7915 • E-Mail : [email protected]

· Company · CEO · Specialty · Head Office · Homepage

Samyang Genexbio Corporation Dr. Hojoon Choi Oncology API and Injections, GMP Manufacturing 31, Jongro-33-gil, Jongno-gu, Seoul, 110-725, South Korea www.samyanggenexbio.co.kr

43

Pharmaceutical

Pharmaceutical Company with the Top-level Sales of Prescription Drugs in the Surgery Market

SHIN POONG PHARM. CO., LTD Shin Poongis the pharmaceutical company with the No. 1 sales of prescription drugs in the Surgery market. Under the management philosophy of ‘for the health of the people’, Shin Poong Pharm.Co.,Ltd specializes in manufacturing remedy drugs with sincere efforts put into producing every single tablet of life-saving drugs ranging from ingredients to finished products based on our state-of-the-art manufacturing facilities and quality assurance system. We are committed to realizing the spirit of Shin Poong 3V (Vision,Venture and Victory) with top- notch competitiveness based on in-house ingredient synthesizing technologies obtained through rigorous R&D efforts and to further developing the company into the one that receives confidence from our customers and that contributes to promoting the wellbeing of human beings. In 2011, Shin Poong developed PYRAMAX® in cooperation with Medicines for Malaria Venture and approved by Korean FDA. PYRAMAX® is the first artemisinin combination therapy to receive an Article 58 positive scientific opinion from EMA for treatment of both strains of malaria: P.falciparum and P.vivax, in adults and children over 20kg and was listed on WHO prequalified medicines in May, 2012.

Main Products

Hyal Forte inj.

Pyramax Tab.

Name

Indication

Phase

Classification

Pyramax Tab. Loxfen CRTab Hyal Forte Inj Clamoxin Tab. Medi-curtain Inj.

Anti-malaria Analgesic Arthritis Anti-biotics Adhesion Barrier

On Market On Market On Market On Market On Market

NME IMD Generic Generic Medical device

R&D Category NME

IMD

Products

Indication

Stage

Pyramax Tab. Pyramax Gran. SP-8203 KR-35454 Loxfen CR Tab. Loxfen Inj. Bontil plus-M Hyal one Derma filler

Anti-malaria Anti-malaria Anti-stroke Anti-osteoporosis NSAIDs NSAIDs Anti-osteoporosis Anti-osteoporosis Derma filler

Launch(Korea) Registration(EMA) Phase 3(Asia, Africa) Pre-clinic(US/Korea) Pre-clinic(Korea) Launch(Korea) NDA(Korea) NDA(Korea) Pre-clinic(US/Korea) Pre-clinic(US/Korea)-Medical device

※ New Molecular Entity, Incrementally Modified Drug

CONTACT US Contact Information Paul Choen, Director • Phone : +82-2-2189-3471 • E-mail : [email protected]

44

Company CEO Specialty Head Office Homepage

SHIN POONG PHARM. CO., LTD CHANG KYUN KIM Manufacture and Sales of the pharmaceutical products 748-31 YOKSAM-DONG, KANGNAM-GU, SEOUL, 135-925, KOREA www.shinpoong.co.kr

Pharmaceutical

For the Healthy Future of Our Customers

SK Biopharmaceuticals Co., Ltd.

SK Biopharmaceuticals is a development-stage pharmaceutical company spun out from SK Holdings, the third-largest conglomerate in South Korea. SK Biopharmaceuticals focuses on discovery and development of new drugs as well as providing custom services for the manufacture and sales of active pharmaceutical ingredients and intermediates of drugs for major companies, in the factories that have been newly approved in Korea for current Good Manufacturing Practices of active pharmaceutical ingredients. SK Biopharmaceuticals, through its affiliate SK Life Science, leads all Korean pharmaceutical companies with 13 authorized INDs in the US. SK Biopharmaceuticals has a preclinical research and development center located in Daejeon, South Korea, and SK Life Science, its business development and clinical research center in New Jersey, for the clinical development of its assets in the areas of epilepsy, neuropathic pain, depression, irritable bowel syndrome, and Parkinson’s disease. The Custom Manufacturing Service Business manufactures active pharmaceutical ingredients for other pharmaceutical company customers. These customers have recognized the quality of the products, the operational efficiency provided by the Korean FDA-approved manufacturing facility in Daejeon, Korea, and technologies proprietary to SK Biopharmaceuticals, such as continuous flow synthesis, low temperature reactions, and catalytic conversions that differentiate the company from other chemical suppliers.

R&D Pipeline Products

CONTACT US Duncan Taylor Senior Director, Business Development SK Life Science, Inc. • Phone : +1-201-421-3842 • E-mail : [email protected]

Haein Shin Senior Manager, Business Development SK Biopharmaceuticals Co., Ltd. • Phone : +882-2-2121-5353 • E-mail : [email protected]

Indications

Diazepam Nasal Spray Carisbamate (YKP509) YKP3089 SKL11197 YKP10811 SKL-DEP SKL-N05 YKP1447 SKL-PD SKL-NP2 SKL-A4R SKL-PSY SKL2020 Pain Project AD Project Schizophrenia Project MS Project ALS Project

· Company · CEO · Specialty · Location · Homepage

Acute Repetitive Seizures Epilepsy, Infantile Spasm (Orphan Designation) Epilepsy, Neuropathic Pain, Bipolar Disorder Neuropathic Pain Chronic Constipation, Irritable Bowel Syndrome Depression Narcolepsy, Drug Addiction Schzophrenia Parkinson’s Disease, Neuroprotection Neuropathic Pain Alzheimer’s Disease Bipolar Disorder Restenosis Pain Alzheimer’s Disease Schizophrenia Multiple Sclerosis Amyotrophic Lateral Sclerosis

Development Stage Pre-NDA Meeting Stage Phase 3 Phase 2 Phase 2 Phase 2 Phase 1 Phase 1 Phase 1 Phase 1 Preclinical Preclinical Preclinical Discovery Discovery Discovery Discovery Discovery Discovery

SK Biopharmaceuticals Co., Ltd. Christopher C. Gallen, M.D., Ph.D. Drug Development Business developing innovative new drugs to treat central nervous system disorders and Custom Manufacturing Business producing pharmaceutical intermediates and active pharmaceutical ingredients 99 Seorin-dong, Jongro-gu, Seoul 110-110, Korea http://www.skbp.com

45

Pharmaceutical

Developing New Chemical Entities, Herbal and Biopharmaceutical Drugs

SK Chemicals Co. Ltd.

The life science part of SK Chemicals is recording continuous sales expansion such as Sunpla the domestic new drug No.1 anti-cancer medicine, Trast the arthritis medicine of domestic market share ranking 1st, joins the domestic natural new drug No.1, etc. Main Products Product

Information

Sunpla Inj. (3 generation Cisplatin)

anti-cancer agent * The 1st Korean new chemical entity

Trast patch (Piroxicam)

Patch formulation with anti-inflammatory

Joins (Clematis mandshurica, Trichosanthes killilowii, Prunella vulgaris ext)

Cartilage protective agent *The 1st Korean new herbal drug

Mvix (Mirodenafil)

Treatment of erectile dysfunction (ED)

rd

R&D Pipeline SK Chemicals focuses on developing new chemical entities, herbal and biopharmaceutical drugs in therapeutic areas with high unmet medical needs. Product

CONTACT US

Information

NCE 401 (RIF, Radio-induced Fibrosis agent)

New Chemical Entity, In preclinical study

NCE 402 (type2 diabetes agent)

New Chemical Entity, in preclinical study at USA.

NCE 403 (BPH, Benign prostatic hyperplasia agent)

New Chemical Entity, in Preclinical study at USA

NBP 601 (anti- Heamophilia agent, 4th generation FactorVIII)

Bio-Better, in Clinical study at USA with CSL

SID 710 (anti-dementia patch, Rivastigmine)

IMD, in Registration at EU

SID 820 (anti-gastric ulcer agent, Esomeprzole freebase)

IMD, in Registration at EU

Name : Sojin, Jung Associate research Scientist • Phone : +82-2-2008-1972 • E-Mail : [email protected]

US BRANCH 400 kelby St. 17th Fl. Fort Lee, NJ 07024 Joon won, Park • Phone : +1-201-753-0300 • E-mail : [email protected]

46

· Company · CEO · Specialty · Location · Homepage

SK Chemicals Co. Ltd. Chang Geun, Kim specialty chemicals and life science business 686,Sampyeong-dong, Bundang-gu, Seongman-si, gyeonggi-do, 463-400 Korea www.skchemicals.com

Pharmaceutical

World Leader in API Custom Manufacture

ST Pharm Co., Ltd.

“ST Pharm provides reliable and timely custom manufacturing services for API following stringent quality system and close communication with the clients.” Founded in 1983, ST Pharm (formerly known as Samchully Pharmaceutical) has been offering excellent custom manufacturing service of APIs and their intermediates to meet clients’ high expectation for their use in pharmaceutical development in compliance with cGMP requirements. Our reliability in service, which is wellproven through decades of business relationship with many big pharmas and biotech clients, is the essence of our strength along with our expertise in process development and scale-up optimization.

Main Products 1. Custom Manufacturing 1) New Drug APIs & Intermediates 2) GMP-Oligonucleotides (for RNA therapeutics) 2. Generic APIs & Intermediates With highly experienced technical teams and synergistic collaboration with a parent company, Dong-A Pharmaceutical, ST Pharm extends the product pipelines to generic APIs and intermediates with supportive DMFs and high-spec quality control required to timely enter domestic and global market. Products List (selected) Category New Drug APIs

Pharmaceutical Intermediates

Generic APIs

Products

Customer

HCV drug HIV drug HIV drug Oligonucleotide Chiral epoxide Chloro-(L)-sugar Nucleoside monomers Stavudine Terizidone Atorvastatin Clopidogrel Olmesartan

Originator (Worldwide) Originator (Worldwide) Originator (Russia) Originator (Worldwide) Originator (Worldwide) Originator (Worldwide) US/EP/JP ROW/EU S.Africa/Germany/CIS Domestic/JP/ROW Domestic/ROW JP/ROW

Indication/Stage HCV/Phase 3 HIV/Marketed HIV/Marketed Oncology/Phase 2 HIV/Marketed HBV/Marketed Various RNA therapeutics/Clinical HIV/Marketed Tuberculosis/Marketed Hyperlipidemia/Marketed Anticoagulant/Marketed Hypertension/Marketed

R&D Pipeline (selected) Category CMO New Drug

Generic APIs

Project Antibiotics Gastritis therapeutics Diabetes therapeutics Anticancer (CRPC) HIV Anticancer MRI contrast media HBV COPD

Goal Commercial in 2013 for clinical trial Commercial in 2014 Pre-clinical in 2014 Pre-clinical in 2014 Released in 2013 Released in 2014 Released in 2015 Released in 2016

CONTACT US Seong-Soo Oh Chief Researcher R&D Planning Team R&D center • Phone : +82-31-488-1409 • E-mail : [email protected]

· Company · CEO · Specialty · Location · Homepage

ST Pharm Co., Ltd. Geun-Jho Lim CMO (New Drug APIs & Intermediates), Generic APIs, Oligo APIs and New Drug Development 7F MSA Bldg., 891-43, Daechi-dong, Gangnam-gu, Seoul, Korea http://www.stpharm.co.kr

47

Pharmaceutical

Leading Biotech Company for Better Life

TAEJOON PHARM. CO., LTD.

Taejoon Pharm Co., Ltd. is a pharmaceutical company with 34-year experience and the first company worldwide to possess technological power in three major areas: the development of new drugs, ophthalmologic drugs and contrast media. Main Products

XALOST

Ophthalmic Solution ▪XALOST (API: LATANOPROST) - Release date: May 2005. - Indication: Reduction of intraocular pressure of the following diseases open-angle glaucoma, chronic angle-closure glaucoma, ocular hypertension. ▪COMBISOPT (API: DORZOLAMIDE HCL, TIMOLOL MALEATE) - Release date: Feb 2011. - Indication: For the treating of disorders such as glaucoma or high eye pressure. Combisopt lowers high pressure in the eye, a problem typically caused by the condition known as open-angle glaucoma. ▪TJ CYCLOSPORINE (API: CYCLOSPORINE) - Release date: After patent expiry. - Indication: Increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. Contrast Media ▪IOBRIX Inj. (API: IOHEXOL) - Release date: Jan 2002. - Indication: Myelography, angiography, urography, contrast enhancement of computerized tomography. ▪IVERSENSE Inj. ( API: IOVERSOL) - Release date: Nov. 2008. - Indication: For cerebral angiography and peripheral arteriography, contrast enhanced computed tomographic imaging of the head and body, venography, and intravenous excretory urography. ▪MRbester Inj. (API: GADOPENTETATE DIMEGLUMINE) - Release date: Feb. 2004. - Indication: MR imaging for the whole body excluding the heart, central nervous system including the brain,spine and associated tissues in adults and pediatric patients. (2 years of age and older)

GMP Certification List No.

GMP

Facility

Year

1 2 3 4

KGMP EU GMP Anvisa GMP Actavis Audit

Sterile ophthalmic solution Sterile ophthalmic solution Sterile ophthalmic solution Vendor audit for sterile ophthalmic solution

2005 2009 2010 2010

R&D Pipeline Product Name CONTACT US Junhee, Lee/ Head of Department • Phone: +82-2-799-0072 • E-mail: [email protected] Minyoung, Hong/ Manager • Phone: +82-2-799-0161 • E-mail: [email protected] Jungkeun, Park/ Staff • Phone: +82-2-799-0163 • E-mail: [email protected]

48

Indications

New quinolone ophthalmic solution New improved drug for dry eye Quinolone new improved drug 1 Quinolone new improved drug 2 New colon-cleansing drug for colonoscopy prep Laxative for constipation Gastritis combination drug

Bacterial conjunctivitis Dry eye Bacterial conjunctivitis Bacterial conjunctivitis Colonoscopy preparation Constipation Gastritis

· Company · Co-CEO · Specialty · Location · Homepage

Current Status Pre-clinical trial Ongoing pre-clinical trial phase 3 Ongoing pre-clinical trial phase 3 Ongoing pre-clinical trial phase 3 Ongoing pre-clinical trial phase 3 Ongoing pre-clinical trial phase 3 Ongoing pre-clinical trial phase 3

TAEJOON PHARM. CO., LTD. Tae Young, Lee/ Joon Youb, Lee Ophthalmic solution, Contrast media. 657-87 Hannam-dong, TAEJOON Bldg., Yongsan-gu, Seoul, Korea www.taejoon.co.kr

Pharmaceutical

Leading Biotechnology Company Targeting Cardiovasucular Disease, Cancer, and Immune-related Disorders

VM BioPharma VM BioPharma, one of the most active drug development companies among world’s small-cap biotech entities, was established in 1996 and has been listed on the KOSDAQ stock exchange (ticker #: 084990) since 2005. The company is focusing on the development of innovative medicines in the areas of cardiovascular disease, neuropathy, cancer and immune disorder. Main Products Product

Target Disease

Technology

Country

Development Stage

USA VM202-PAD

Critical Limb Ischemia

DNA

Korea

Phase II (Patient Enrollment)

China VM202-DPN

Diabetic Peripheral Neuropathy

VM202-CAD

Chronic Refractory Myocardial Ischemia

VM501

Thrombocytopenia

VM206

Breast Cancer

DNA

USA Korea

Phase II (Patient Enrollment)

DNA + Noga XP

USA

Phase I/II (IND Approved)

DNA + direct injection

Korea

Phase I (Completed) Phase II/III (Planned)

Protein

China

Phase III (Patient Enrollment)

DNA + Virus

Korea

Phase I (Patient Enrollment)

VM202 – DNA Therapeutics Inducing Angiogenesis and Nerve Regeneration VM202 is a DNA-based medicine for the treatment of ischemic cardiovascular diseases such as coronary artery disease and peripheral artery disease. It is designed to express two isoforms of hepatocyte growth factor (HGF), which induces the formation of new blood vessels when injected into the ischemic sites. These new collateral vessels will increase blood flow and tissue perfusion, thereby effectively treating ischemia. VM202 also treats diabetic peripheral neuropathy (VM202-DPN) by stimulating the growth and regeneration of nerve cells. For VM202 to enter the global market, the company is carrying out multinational late stage clinical trials in the US, China, and Korea. Selected References: Senda AD et al., Annals of Neurology, Submitted / Henry TD et al., Gene Therapy 2011;18:788-794 / Gu et al., The Journal of Gene Medicine, 2011;13:602-610 / Saeed M et al., Cardiovasc Revasc Med. 2011;12:111-122 / Pyun WB et al., Gene Therapy 2010;17:1442-1452 / Saeed M et al., Radiology 2008;249:107-118 / Cho KR et al., Eur J Cardiothorac Surg 2008;34:857-863 / Carlsson M et al., American Jour of Physiology 2008;295:H522-532 VM501 – Protein Therapeutics for Thrombocytopenia VM501 is a re-engineered form of interleukin 11(IL-11) targeting chemotherapy-induced thrombocytopenia (CIT). It has been shown to induce an increase in the number of blood platelets. In Phase I and Phase II clinical trials performed in China, significant therapeutic effects were shown without severe adverse effects. Phase III clinical trial is currently ongoing in 18 hospitals in major cities of China including Beijing, Tianjin and Dalian. VM206 – Therapeutic Cancer Vaccine VM206 is a therapeutic cancer vaccine that has potential applications for breast, ovarian, and pancreatic cancers. The pre-clinical efficacy data was published in Gene Therapy (2008, 15, 1351-1360) and Phase I clinical trial is currently ongoing in Korea.

CONTACT US Youngtae Hong Team Manager, Strategic business • E-mail : [email protected]

· Company · CEO · Specialty · Location · Homepage

VM BioPharma Kim Yongsoo 1) DNA/protein-based biopharmaceuticals 2) Phytotherapeutics (botanical drugs/nutraceuticals) Bldg 203, Seoul National University, # 599 Gwanak-ro, Gwanak-gu, Seoul, Korea www.viromed21.com

49

Pharmaceutical

Best Partner Best Yuhan

Yuhan Corporation

Equipped with the state-of-the-art cGMP manufacturing facilities and extensive research capabilities, Yuhan is growing into a global pharmaceutical company offering one stop services from R&D to commercial production of intermediates, APIs, and finished products. Yuhan has undergone successful audits by many international regulatory agencies such as the US FDA, the EU EMA/EDQM, the Australian TGA, and the Japanese PMDA. Yuhan’s overseas’ business activities include: - New drug development projects with multinational partners. - Developing and optimizing cost effective synthetic processes for APIs and intermediates. Yuhan is committed to deliver the best medicines to the world for improving the health and quality of human life. Beginning with the out-licensing to China of Yuhan’s ‘Revanex’, the world’s first acid pump agonist, Revanex is now supplied worldwide to markets in India and Southeast Asia. Yuhan is continuously expanding its overseas markets with finished products.

Products Product/Project

Indication

Revanex

Gastritis

Feature & Strength

YH4808

GERD

NCE drug, on phase 2, 2nd generation APA. Fast onset-time and cleaner adverse effect profile than current PPI

YH12852

IBS

NCE drug, expected to fulfill unmet medical needs for IBS treatment, Comparative advantage of efficacy and safety to current market players

NCE drug, NDA (2007), World-first acid pump antagonist (APA)

R&D Pipeline

CONTACT US Head Quarters 49-6, Daebang-dong, Dongjak-gu, Seoul, 156-754, Korea • Phone : +82-2-828-0181 • Fax : +82-2-828-0300

50

· Company · CEO · Specialty · Location · Homepage

Yuhan Corporation Yoon Searb, Kim Pharmaceutical Daebang-dong, Dongjak-gu, Seoul, Korea http://www.yuhan.co.kr/Eng/index.asp

Supplement 1. Products Expected to Export 2. Technology Transfer 3. Certifications from Health Authorities

1. Products Expected to Export Supplement

Company

Ahngook pharm. co.Ltd

BCWORLD PHARM. CO., LTD.

Binex Co., Ltd.

BIONEER CORPORATION

Boryung Pharmaceutical co., Ltd.

Chong Kun Dang Pharmaceutical Corp.

CJ Cheil Jedang Corp.

52

Product name

Active Ingredient

Indication

Category

Expected country

Note

Synatura syrup

Dried Ivy leaf ext. 262.5mg + Coptis Rhizome Butanol Dried ext. 87.5mg among 100ml

Relief of cough and sputum due to acute respiratory infection and chronic inflammatory bronchitis

Prescription (ETC)

Global (Specially EU)

-

Anycough Cap.

Theobromine 300mg

Relief of cough symptoms caused by postnasal drip, gastroesophageal reflux disease, bronchiectasis and chronic bronchitis

Prescription (ETC)

Global

-

Xaltrin XL Tab.

Alfuzosin HCl 10mg

- Treatment of the functional symptoms of benign prostatic hypertrophy (BPH) - Adjuvant therapy for catheter in acute urinary retention related to BPH

Prescription (ETC)

Global

-

Anyfen syrup

Fever by acute respiratory infection

-

Global

-

Mepem Inj. 1g

Meropenem

Antibiotics

Sinraci Inj. 500mg

Antibiotics

Vitamin Inj.

Imipenem/ Cilastatin Sodium Vitamin A, Vitamin C, etc.

Well-being products

Morphine Sulfate Inj.

Morphine Sulfate

Narcotics

BC Atorvastatin Tab.

Atorvastatin Calcium

Lipid-Lowering agents

Remiba Inj.

Remifentanil HCl

Narcotics

human Growth Hormone

Somatropin

Growth Hormone Deficiency

Prescription (ETC) Prescription (ETC) Prescription Medicine Prescription Medicine Prescription Medicine Prescription Medicine Prescription Medicine Prescription Medicine Biological Product

Global

Letopra Tablet

Dexibuprofen 12mg among 1mL S-Pantoprazol 10mg/20mg

World

-

Biscan tablet

Bacillus polyfermenticus n.sp.

Probiotics

US, EU, etc.

-

Biscan-N tablet, powder

Bacillus Licheniformis

Normalization of bowel movement, abdominal inflation, loose feces, constipation, abdominal fermentation in intestine Normalization of bowel movement, abdominal inflation, loose feces, constipation, abdominal fermentation in intestine

Probiotics

US, EU, etc.

-

SAMiRNA-Survivin

RNA

Solid cancer

RNAi drug

Worldwide

-

SAMiRNA-COPD target genes

RNA

COPD(chronic obstructive pulmonary disease)

RNAi drug

Worldwide

-

Kanarb

Fimasartan

Hypertension

Prescription medicine

Global

-

D-Taxel

Docetaxel

Oncology

Prescription medicine

DOXORUBICIN

DOXORUBICIN

Oncology

API

PITAVASTATIN

PITAVASTATIN

Hypertension

API

ASIA, LATIN AMERICA, MIDDLE EAST EU, JAPAN, CHINA, AMERICA EU, JAPAN, CHINA, AMERICA

TacroBell

Tacrolimus

Immunosuppressant

Worldwide

-

Cipol N

Ciclosporin

Immunosuppressant

Worldwide

-

My-Rept

Mycophenolate mofetil

Immunosuppressant

Worldwide

-

Gemtan

Gemcitabine

Anti-cancer

Worldwide

-

Belotaxel

Docetaxel

Anti-cancer

Worldwide

-

Citopcin inj. Tapocin inj. CJ Vancomycin inj. Epokine inj. Leukokine inj.

Ciprofloxacin Teicoplanin

Infection Infection

Prescription Medicine Prescription Medicine Prescription Medicine Prescription Medicine Prescription Medicine Antibiotics Antibiotics

-

-

Vancomycin

Infection

Antibiotics

-

-

Erythropoietin Filgrastim

Anemia Neutropenia

Biologicals Biologicals

-

-

Mid ~ Severe GERD (gastroesophageal reflux disease )

US, EU, ASIA

-

-

Daewon Pharmaceutical Co., Ltd. Daewoong Pharmaceutical Co., Ltd.

Dong-A Pharmaceutical

Green Cross Corp.

HANLIM PHARM. CO., LTD.

IL-YANG PHARMACEUTICAL CO., LTD.

Tulobuterol

Respiratory distress

Prescription Medicine

Worldwide

-

Aceren cap.

Diacerein

Rheumatoid arthritis, osteoarthritis

Prescription Medicine

Worldwide

-

Almetamine tab.

Betamethasone, Dexchlorpheniramine maleate

Adrenal cortical hormone

Prescription Medicine

Worldwide

-

Bidica tab.

Biphenyl dimethyl dicarboxylate

Chronic persistent and active hepatitis

Prescription Medicine

Worldwide

-

Protase tab.

Bromelain, Crystallized Trypsin

Fracture, sprain, incarcerated hemorrhoid

OTC Product

Worldwide

-

Pelubi Tab.

Pelubiprofen

NSIADs

Prescription Medicine

US, EU

-

Oramin Cap.

Multivitamins

Multivitamin

OTC Product

US, EU

-

URSA

Ursodeoxycholic acid

Hepatobiliary Diseases

OTC/ETC

Worldwide

-

Meropenem

Meropenem

Antibiotics

ETC

Worldwide

-

Easyef

rhEGF

Diabetic foot ulcer, traumatic wound, skin ulcer

Biological

Worldwide

-

Caretropin

Somatropin

Growth hormone deficiency

Biological

Worldwide

-

Luphere

Leuprolide acetate

Prostate cancer, Breast cancer

ETC

Worldwide

-

Zydena

Udenafil

Erectile dysfunction

Prescription medicine

EU, etc.

-

Monotaxel

Docetaxel

Anti-cancer

Prescription medicine

EU, etc.

-

-

Epirubicin

Anti-cancer

API

EU, etc.

-

China, etc.

-

Closerin

Cycloserine

Anti TB

Prescription medicine

Gonadopin

Follitropin

FSH

Prescription medicine

etc.

-

GreenGene F inj.

Beroctocog alfa (Blood coagulation factor VIII, recombinant)

For the prevention and control of bleeding episodes and preoperative management in Hemophilia A

Biological Product

USA, Europe, Latin America, Asia Middle East, etc

-

GC FLU inj.

Purified Inactivated Influenza Virus Antigen Type A (H1N1) Purified Inactivated Influenza Virus Antigen Type A (H3N2) Purified Inactivated Influenza Virus Antigen Type B

For the Prophylaxis against Influenza

Biological Product

USA, Latin America, Asia, Middle East, etc

-

Hunterase

Idursulfase-ß

For patients with Hunter Syndrome (Mucopolysaccharidosis II, MPS II) as an enzyme replacement therapy

Biological Product

USA, Europe, Latin America, Asia, Middle East, etc

-

DAGES CAP

Pepsin etc.

Polyenzymatic digestant

OTC Product

Vietnam, Chile etc.

-

LODIEN TAB

s-Amlodipine Nicotinate

Antihypertensives

Prescription Medicine

Vietnam, Chile etc.

-

HYALURON EYE DROPS

Hyaluronate Na

Epithelial protector of cornea& conjunctiva

Prescription Medicine

US,India etc.

-

NASATIVE NASAL SPRAY

Mometasone furoate

Antiallergics

Prescription Medicine

US,India etc

-

TROPIN INJ.

Dopamine HCI

Cardiac drugs

Prescription Medicine

Vietnam, Chile etc.

-

SUPECT Cap.

radotinib

Ph (+) chronic myeloid leukemia (CML) in chronic phase (CP) or accelerated phase (AP)

prescription medicine

-

-

Noltec tab

Ilaprazole

gastric ulcer, duodenal ulcer, gastroesophageal reflux disease, non-erosive reflux disease

prescription medicine

-

-

WONBI-D LIQUID

Korea Ginseng

Improves Health

OTC Product

EU

-

Sol + LIQUID

Taurine, Multi Vitamin

Improves performance

Beverage/ Energy Drink

EU/ASIA

-

Aldrin Suspension

Almagate 1.5G/1G

Antacid action

OTC Product

EU/ASIA

-

Supplement

Dae Hwa Pharmaceutical Co. Ltd.

Resnalin patch

53

Supplement

Kolmar Korea Co., Ltd.

Korea United Pharm. Inc.

Kuhnil Pharmaceutical Co.,Ltd

Kwang Dong Pharmaceutical Co., Ltd.

LG Life Sciences, Ltd.

ZERO-X Cap.

Orlistat

Anti-obesity Agents

Prescription Medicine

GLITOL Tab.

Miglitol

Anti-Diabetics

Prescription Medicine

MAXFORGE Tab.

Valsartan and Amlodipine

Antihypertensive

Prescription Medicine

Taminal Cap.

Tamsulosin HCl

BPH

Prescription Medicine

Denti-lid Cap.

Titrated extract of the unsaponifiable fraction of Zea mays L.

Periodontal Disease

OTC Product (Lidcaps)

Clanza CR Tabs.

Aceclofenac 200mg

analgesic

Clavixin Duo Caps.

Clopidogrel 100mg / Aspirin 75mg

antithrombotic

Cilostan CR Tabs.

Cilostazol 200mg

antithrombotic

Caspofungin for Inj. 70 mg

Caspofungin acetate

Antifungal Agents

IMD(New Controlled Release Drug) IMD(New Combinational Drug) IMD(New Controlled Release Drug) Prescription Medicine

Tigecycline for Inj. 50 mg

Tigecycline

Antibiotics

Gadopentatic Inj.

Gadopentatic acid

Alprostadil Inj.

-

EU, South America

launched

US, EU, South America

launched

US, EU, South America

In registration

worldwide

-

Prescription Medicine

worldwide

-

MRI contrast

Prescription Medicine

worldwide

-

Alprostadil

Vasodilators

Prescription Medicine

worldwide

-

Somatostatin for Inj. 3 mg

Somatostatin acetate

Hormone & Synthetic Agents

worldwide

-

Bicalude Tablet

Bicalutamide 50mg

anti-cancer

Lenara Tablet

Letrozole 2.5mg

anti-cancer

Prescription Medicine Prescription Medicine Prescription Medicine

Woohwang chungsimwon

stroke, hypertertension

Ketoprofen

variety herbal ingredient ketoplus cataplasma 60mg

KD-fen

Diclofenac 120mg

Analgesia, anti-inflammatory

EPO

Erythropoetin

Anemia in chronic renal disease

rFSH

recombinant FSH

Infertility

hGH

human Somatropin

Growth hormone deficiency

Hyruan plus/SIHA

Hyaluronic acid

Joint arthritis

Yvoire

Hyaluronic acid

Wrinkle correction

Neuronox®

Botulinum toxin type A

Wrinkle correction

Biological Product (Prescription medicine)

Neuramis® Deep

Hyaluronic acid

Wrinkles

Medical Device

Paclitaxel

Anti-cancer

Prescription Medicine

Paclitaxel

Anti-cancer

Prescription Medicine

Medytox

® Samyang Genexol Injection Biopharm -aceuticals Corporation. Corporation.

54

EU South America Asia EU Asia Middle East Asia Middle East Africa Asia Middle East Africa Asia Middle East Africa

degenerative arthritis

all over the world all over the world all over the OTC Product world all over the OTC Product world all over the OTC Product world MENA, Biological Brazil, product Russia MENA, Biological Mexico, product Brazil Mexico, Biological Russia, product Southeast Asia MENA, Southeast Medical device Asia, Eastern Europe MENA, Southeast Medical device Asia, Eastern Europe Southeast Asia MENA, Southeast Asia Eastern Europe MENA, Southeast Asia

-

-

-

-

-

Cremophor free formulation

SHIN POONG PHARM. CO., LTD

SK Chemicals Co. Ltd.

ST Pharm Co., Ltd.

TAEJOON PHARM. CO., LTD.

Eastern Europe

Tween-80 free formulation

NSAIDs

OTC Medicine

EU, MiddleEast, Asia, Russia, CSI, Africa, America, etc.

-

Rivastigmine

Anti-Parkinson Anti-Alzheimer

Prescription Medicine

Hyal Inj.

Sodium hyaluronate

Rheumatic drugs

Prescription Medicine

world wide

-

Hyal Forte Inj.

Sodium hyaluronate

Rheumatic drugs

Prescription Medicine

world wide

-

Varodipine Tab.

Amlodipine besylate

Anti-hypertension

Prescription Medicine

world wide

-

Hivix Tab.

Clopidogrel bisulfate

Anti-thrombotic

Prescription Medicine

world wide

-

Losarcin Tab.

Losartan potassium

Anti-hypertension

Prescription Medicine

world wide

-

Esomeprazole capsule

Esomperazole free base

Anti-ulcer

Prescription medicine

EU

-

Prescription medicine

Asia, Middle east

Already licensened in EU,US and South Amreica

Docetaxel

Rheumastop® Plaster

Diclofenac diethylamine

Rivastigmine Patch

Anti-cancer

Supplement

Samyang Biopharm -aceuticals Corporation.

Prescription Medicine

Nanoxel®-M Injection

EU, MiddleEast, API Asia, Russia, &Lower same PK CSI, Africa, America, etc.

Rivastigmine patch

Rivastigmine

Alzheimer’s disease

Albumin 20%

Human Albumin

Hypoalbuminemia

Prescription Asia, Middle medicine east, South (Blood product) America

Liv-Gamma (SN)

Human Immunoglobulin

Agammaglobulinemia & others

Prescription Asia, Middle medicine east, South (Blood product) America

Factor VIII

Plasma derived Factor VIII

Factor VIII deficiency

Prescription Asia, Middle medicine east, South (Blood product) America

TRAST

Piroxicam

Osteoarthritis, Tenosynovitis, Myalgia, & others

OTC product

Asia, South America

Joins

Clematis mandshurica, & others.

Osteoarthritis

Prescription medicine

Asia, South America

-

Mvix

Mirodenafil

Erectile Dysfunction

Prescription medicine

Asia, South America

-

-

Zidovudine Stavudine Terizidone Clopidogrel Bisulfate

anti HIV/AIDS anti HIV/AIDS anti Tuberculosis Anti-coagulant

API API API API

US, EU etc. US, EU etc. US, EU etc. US, EU etc.

-

-

Atovastatin Calcium Anhydrous

Metabolic disease

API

US, EU etc.

-

Xalost

Latanoprost

Anti-glaucoma

Prescription Medicine

US

-

Xalostplus

Latanoprost plus Timolol maleate

Anti-glaucoma

Prescription Medicine

US

-

Alpadine

Olopatadine

Conjunctivitis

Prescription Medicine

US,EU

-

MC FREE

Sodium CMC

Dry eye

Prescription Medicine

US,EU

-

Iobrix

Iohexol

Angiography

Prescription Medicine

US,EU,etc

-

Approved in several Asian countries Approved in several Asian countries Expected launch date : Late Y2013 Exporting to some Asian countries

55

2. Technology Transfer Supplement

Company Ahngook pharm. co.Ltd

BCWORLD PHARM. CO., LTD. BIONEER CORPORATION Boryung Pharmaceutical co., Ltd. Bukwang Pharmaceutical Co., Ltd.

Chong Kun Dang Pharmaceutical Corp.

CJ CheilJedang Corp.

Crystal Genomics

Dae Hwa Pharmaceutical Co. Ltd.

Targeted country

Note

Preclinical Preclinical

Global Global except EU

-

Launching Oct 2012

Phase 4

Global

-

Cancer Cancer Hyperlipidemia Schizophrenia Solid cancer

Preclinical Preclinical Preclinical Preclinical Preclinical

Preclinical

RNAi drug

COPD(chronic obstructive pulmonary disease)

Preclinical

New chemical Entity

Hypertension

Small Molecule

Cancer

Indication

Herbal Small molecule

Respiratory(Relief of cough) Respiratory(Relief of cough)

Launched Launched

Small molecule

Gastro-intestine (GERD)

Biologics Biologics Small molecule Small molecule RNAi drug

Worldwide

-

Preclinical

Worldwide

-

Launching

Launching

Global

-

Phase 1/2a

Phase 1/2a

EU, Japan

-

South America, EU

-

US, EU, ASIA

Nucleoside

Hepatitis B virus

Launched

Launched NDA

Small molecule

Cancer

Launching

-

China, Taiwan, Macau

-

Small molecule

Diabetes

Pre-registration

-

Worldwide

-

Small molecule

Cancer

Phase 1

-

Worldwide

-

Small molecule

Cancer

Phase 1

-

Worldwide

-

Biosimilar

Anemia

Phase 1

-

Worldwide

-

Vaccine

Human Papillomavirus (HPV) Vaccine

Preclinical

-

China

-

Small molecule

GERD

Phase 1

Phase 1

China

-

Small molecule

Diabetes

Phase III

n/a

China, SE Asia

-

small molecule

Osteoarthritis (Inflammation, Pain)

Completed Phase IIb

-

US, EU, China, Japan, etc

-

small molecule

MRSA, VRSA infection

-

Phase IIa

US, EU, China, Japan, etc

-

small molecule

Cancer

Phase I(MAD)

-

US, EU, China, Japan, etc

-

Small molecule

Cancer

Phase 3

-

Worldwide

-

Manufacturing method of solubilize composition of paclitaxel

Cancer

Phase 3

-

US, EU, etc.

-

TDS tech.

Analgesic

Phase 3

-

Worldwide

-

Small molecule

Diabetes

Launching

-

Worldwide

-

TDS tech.

Respiratory

Launching

-

Worldwide

-

small molecule

Rheumatoid Arthritis

Launching

-

-

-

small molecule

antitussive

Launching

-

-

-

small molecule

appetite stimulant

Phase 1

-

-

-

Small molecule

Neuropathic pain

Phase 2

-

Worldwide

-

Small molecule

Alzheimer’s disease

Phase1

-

Worldwide

-

Small molecule

Fungal Infection

Preclinical

-

Worldwide

-

Biologic

Cancer

-

Worldwide

-

Biologic/ Medical Device

Spine and Oromaxillofacial (BMP-2)

Phase1 Completed Clinical Trials Completed

-

Worldwide

-

DONGWHA PHARM

Qunolones-Antibiotic

Antibiotics

Phase 2 completed

Phase 1 completed

US, EU, JP, CN, RU

-

Dong-A Pharmaceutical

API

Cancer

Launching

-

EU, etc.

-

API

Erectile dysfunction

Launching

Launching

EU, etc.

-

Small molecule

Age related Macular Degeneration

Preclnical

-

USA EU

-

IMD

Osteoarthritis

Phase 2

-

USA, EU East Asia South America

-

Daewon Pharmaceutical Co., Ltd.

Daewoong Pharmaceutical Co., Ltd.

HANLIM PHARM. CO., LTD.

56

Development Status Korea Overseas

Category

Kwang Dong Pharmaceutical Co., Ltd.

LG Life Sciences, Ltd.

Medytox

Samyang Biopharm -aceuticals Corporation.

SHIN POONG PHARM. CO., LTD

SK Biopharmaceuticals Co., Ltd.

SK Chemicals Co. Ltd.

Yuhan Corporation

Hypertension

Phase 1

-

IMD

Perennial allergic rhinitis

Approval

-

Herbal

Asthma

Preclinical

-

Oral disintegration film

Treatment of erectile dysfunction

Launching

Small molecule

Diabetes

Launching

Biologics

Rheumatoid arthritis

Small molecule

USA, EU East Asia South America Japan, EU East Asia South America USA EU

-

all over the world

-

Phase 3

Worldwide

DPP IV inhibitor

Preclinical

N/A

Worldwide

Antibody biosimilar

Myocardial infarction

Phase 1

N/A

Worldwide

-

Small molecule

Gout

Phase 1

N/A

Worldwide

XO inhibitor

Small molecule Biologics(1) (Botulinum toxin product) Biologics(2) (Botulinum toxin product) polymer-based parenteral DDS tech.

Atherothrombosis

Phase 1

N/A

Worldwide

Glabellar Wrinkles, etc.

-

phase 2

EU/US

Glabellar Wrinkles, etc.

phase 1

-

EU/US

Anti-cancer

launching

Ph 2

US, EU

polymer-based parenteral DDS tech.

Anti-cancer

Ph 1 (completed)

Preclinical

US, EU

TDS tech.

Neuropathic pain

Ph 2 (completed)

Preclinical

US, EU

TDS tech.

Severe pain

Ph 1 (completed)

Preclinical

US, EU

Oral DDS tech.

-

Preclinical

Preclinical

US, EU

SP-8203

Anti-stroke

Preclinical

Preclinical

world wide

Medicurtain®

Anti-adhension

Launched

Preclinical

world wide

SP5M001

Osteo-arthrosis

Preclinical

Preclinical

world wide

P2Y12 inhibitor License Out License Out Solubility enhancing Solubility enhancing, Sustained release Lower API & same PK Launch expected in 2012 Oral BA enhancing technology Supported by Ministry of Knowledge Economy Supported by Ministry of Knowledge Economy -

SP5V003

Dermal filler

Preclinical

Preclinical

world wide

-

KR35454

Osteoporosis

Preclinical

Preclinical

world wide

-

Pre-NDA meeting

Japan, South Asia (India, Malaysia, the Philippines etc.)

-

Formulation

Seizure, anxiety

-

Small molecule

Sleep awake

-

Small molecule Small molecule ALK5 inhibitor 11ß-HSD1 inhibitor

-

Preclinical

US, EU, Japan

-

HMP302

Seizure, neuropathic pain Neuropathic pain Fibrotic disease Diabetes, Obesity endometriosis, uterine myoma, BPH, and breast/ prostate cancers. Alzheimer’s disease

Phase III

-

US, EU

Botanical origin

SK910 (Anastrozole depot injection)

Breast cancer

Preclinical

-

US, EU

-

GnRH antagonist

Korea, China, P2b start (4Q) Japan, South Asia P2b (on-going) Japan, EU P2a (on-going) Japan, EU Preclinical US, EU, Japan Preclinical US, EU, Japan

Supplement

HANLIM PHARM. CO., LTD.

IMD

-

IMD

Otitis media

Preclinical

-

US, EU, etc

-

small molecule

GERD

Phase 2, 3

Phase 1 (US)

US, EU, etc

-

small molecule

IBS

Phase 1

-

US, EU, etc

-

small molecule

Arteriosclerosis

Screening

-

US, EU, etc

-

small molecule

Diabetes

Screening

-

US, EU, etc

-

57

3. Certifications from Health Authorities Supplement

Company

Ahngook pharm. co.Ltd

Boryung Pharmaceutical co., Ltd.

Chong Kun Dang Pharmaceutical Corp.

Active Ingredient

dosage form

Indication

International certification

Note

Synatura syrup

Dried Ivy leaf ext. 262.5mg + Coptis Rhizome Butanol Dried ext. 87.5mg among 100ml

Syrup

Relief of cough and sputum due to acute respiratory infection and chronic inflammatory bronchitis

KGMP certification

-

Anycough Cap.

Theobromine 300mg

Capsule

Relief of cough symptoms caused by postnasal drip, gastroesophageal reflux disease, bronchiectasis and chronic bronchitis

KGMP certification

-

Xaltrin XL Tab.

Alfuzosin HCl 10mg

Tablet

Treatment of the functional symptoms of benign prostatic hypertrophy (BPH) Adjuvant therapy for catheter in acute urinary retention related to BPH

KGMP certification

-

Anyfen syrup

Dexibuprofen 12mg among 1mL

Syrup

Fever by acute respiratory infection

KGMP certification

-

Letopra Tablet

S-pantoprazol 10mg / 20mg

Tablet

Mid~Severe GERD

KGMP certification

-

DOXORUBICIN

DOXORUBICIN

API

Oncology

EU GMP

scheduled

Sepirom

Ceftriaxone Sodium hydrate

Injection

Antibiotics

PMDA certification

-

Rasenazolin

Cefazolin sodium

Injection

Antibiotics

PMDA certification

-

Pengood

Bacampicillin hydrochloride

Tablet

Antibiotics

PMDA certification

-

Kmoxilin

Amoxicillin/Potassium clavulanate

Tablet

Antibiotics

Anvisa certification

-

CJ Cheil Jedang Corp.

Cefotaxime inj.

Cefotaxime

Injection

Infection

Japan DMF

-

Ceftazidime inj.

Cephtazidime

Injection

Infection

Japan DMF

-

Ceftriaxone inj.

Ceftriaxone

Injection

Infection

Japan DMF

-

DONGHWA PHARM

-

Pantoprazole(API)

-

Anti-ulcerants

EU GMP certification

-

Closerin

Cycloserine

Capsule

Anti TB

WHO GMP certification

-

-

Zidovudine

API

HIV

cGMP Certification

-

Factive

Gemifloxacin

Tablet

Antibiotics

FDA GMP certification

-

hGH

human Somatropin

Injection

Growth hormone deficiency

FDA GMP certification EU GMP certification

-

-

Dong-A Pharmaceutical

LG Life Sciences, Ltd.

Medytox

58

Product name

Euvax B

Hepatits B vaccine

Injection

Hepatits B vaccine

WHO GMP certification EU GMP certification

Euforvac-Hib

DTP-HepB-Hib vaccine

Injection

DTP-HepB-Hib vaccine

WHO GMP certification

-

Hyruan plus

Hyaluronic acid

Injection

Joint arthritis

CE certification

-

Biologics(1) (Botulinum toxin product)

Botulinum toxin type A

Vial (lyophilized)

Glabellar Wrinkles, etc.

cGMP & EU GMP

Under contruction and completion in 2013.

SHIN POONG PHARM. CO., LTD

SK Chemicals Co. Ltd.

ST Pharm Co., Ltd.

TAEJOON PHARM. CO., LTD.

Diclofenac diethylamine

Plaster

NSAIDs

Australia (TGA) GMP certification

-

Anti-cancer Injection

Anti-cancer Injection

Injection

Anti-cancer

Iran (MOH) GMP certification

-

Genexol

Paclitaxel

Injection

Anti-cancer

EU GMP certification

(DE)

Genexol

Paclitaxel

Injection

Anti-cancer

Hungary (NIP) GMP certification

-

Genexol

Paclitaxel

Injection

Anti-cancer

Egyptian (HMA) GMP certification

-

PYRAMAX®

Pyronaridine & Artesunate

Tablet

Anti-malaria

EU GMP Certification

-

Omeprazole tablet

Omeprazole free base

Tablet

Antiulcer

EU GMP certification

-

Esomeprazole capsule

Esomeprazole free base

Capsule

Antiulcer

EU GMP certification

-

Rivastigmine patch

Rivastigmine free base

Transdermal patch

Agent for Alzheimer’s disease

EU GMP certification

-

-

Zidovudine

API

anti HIV/AIDS

US FDA GMP-API

-

-

Zidovudine

API

anti HIV/AIDS

WHO/EDQM GMP-API

-

-

Zidovudine

API

anti HIV/AIDS

PMDA GMP-API

-

-

Zidovudine

API

anti HIV/AIDS

TGA GMP-API

-

-

Zidovudine

API

anti HIV/AIDS

ANVISA GMPAPI

Xalost

Latanoprost

Solution

Anti-glaucoma

EU GMP certification

-

Xalostplus

Latanoprost plus Timolol maleate

Solution

Anti-glaucoma

EU GMP certification

-

Supplement

Samyang Biopharm -aceuticals Corporation.

Rheumastop

59

memo

60

memo

61

memo

62

Korea Innovative Pharmaceutical Company

Supported by

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