korea biopharmaceutical industry

KoreaBiopharmaceutical

Industry- Present and Future

Korea Biopharmaceutical Industry - Present and Future

CONTENTSI. Status of Biopharmaceutical Industry in Korea 3

II. WHO Prequalification(WHO-PQ) Products 12

III. Company introduction 15

1. Anterogen Co., Ltd 162. Bioneer Corporation 183. Boryung Pharmaceutical co., Ltd 204. Celltrion, Inc. 225. CJ HealthCare Corp. 246. Daewoong Pharmaceutical Co., Ltd 267. GeneOne Life Science, Inc. 288. Genexine, Inc. 309. Green Cross Corp. 3210. HanAll BioPharma Co. Ltd. 3411. Hugel 3612. IL-YANG PHARMACEUTICAL CO., LTD. 3813. ISU Abxis Co., Ltd. 4014. GemVax & KAEL Co., Ltd. 4215. Kolon Life Science, Inc. 4416. LG Life Sciences, Ltd. 4617. MEDIPOST Co., Ltd 4818. Medytox 5019. Samsung Biologics 5220. Samyang Biopharmaceuticals Corporation. 5421. Sewon Cellontech Co., Ltd. 5522. SK Chemicals Co. Ltd. 5823. Tego Science, Inc. 6024. ViroMed. Co., Ltd. 62

I Status of BiopharmaceuticalIndustry in Korea- Korea Biomedicine Industry Association

Status of Domestic Industry

Development Status of Biological Products

II WHO Prequalification(WHO-PQ) Products

Status of Biopharmaceutical Industry in Korea- Korea Biomedicine Industry Association

(Market size) The Korean biopharmaceutical market (approx. 2.2 billion USD) accounts for about 11.4% of total Korean pharmaceutical market (approx. 18.8 billion USD), showing gradual increase.

ㆍ The market share of biological products: 6.1%(2007) -> 6.9%(2009) -> 11.4% (2013)

Biopharmaceutical market size in Korea (Unit: Million KRW, %)

Variables 2007 2008 2009 2010 2011 2012 2013

Biological products

Production 8,243 9,490 12,919 15,064 11,950 17,313 18,654

Export 2,230 3,199 4,322 3,343 2,550 3,753 4,044

Import 3,235 3,390 3,957 5,547 6,366 5,988 7,358

Trade balance -1,004 -190 365 -2,204 -3,815 -2,235 -3,314

Market size 9,247 9,680 12,553 17,268 15,765 19,548 21,968

Market Size of total pharmaceuticals

150,620 169,576 179,700 189,084 189,438 188,900 193,365

Share of Biological products in total pharmaceutical market

6.1 5.7 6.9 9.1 8.3 10.3 11.4

Note: 1) The amount of Export/Import was calculated by using the annual average exchange rate of KRW/USD from the Bank of Korea; 2) Trade Balance = Export (amount) – Import (amount); 3) Market Size = Production + Import – Export

Sources: The trade balance and market size were calculated based on figures of the Production, Export, and Import of Biological products included in the Annual Statistical Report of Food and Drug, 2014.

(Market trend) Both major enterprises and existing pharmaceutical

companies are making increased investment in biological productsin Korea.

ㆍ Korean companies are competing to secure a lead in the biological products market by increasing investment in R&D. The number of bio-venture companies has grown by 180% in the past ten years.

- Major domestic companies such as CJ Healthcare, Celltrion and SK Chemical are now leading domestic market through steady R&D investment, based on stable revenue

* R&D investment by major companies: Celltrion 167.7 billion KRW (’13), LG 75 billion KRW (’13), SK 59.5 billion KRW (’13), Samsung 2.2 trillion KRW (~’16)

* The number of Bio-venture companies has increased 1.8 times (738 (2003) -> 1,317 (2013))

ㆍ Korean biopharmas have strengthened their capacity by developing the world’s first stem cell product and gaining approval for the world’s first biosimilar antibody product from MFDs and EMA. * The world’s first stem cell product was developed by FCD Pharmicell as of Jul 2011. The

world’s first biosimilar antibody product, Remsima inj (Celltrion) was approved by MFDS and EMA as of Jul 2013.

- Total of 60 products including vaccine, biosimilar, cell therapy products are now in clinical trials. Additional 32 domestic products will be launched in the future (as of 2014).

* Total of 839 biological products have been approved (555 domestically manufactured items, 284 imported items) : vaccines 35.8%, plasma derivatives 35.9%, antitoxins 2.6%, recombinant products 23.8%, cell therapy products 1.9%

Current status of domestic biologic product pipelines (as of 2014)

Development stage

Clinical trial (Phase I, II)

Clinical trial (Phase III)

Number of approved products

Number of products expected

to be launched (Cumulative, as of

2018) Biosimilars 9 6 4 4 7

Stem cell therapy 7 17 2 4 6

Gene therapy 5 11 1 0 1

Vaccines 10 5 5 4 18

Total 31 39 11 12 32Sources: Minister of Food and Drug Safety (Feb 2015)

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Status of Domestic Industry1

I

Status of BiopharmaceuticalIndustry in Korea

Korean biopharmas are striving to accelerate expansion into the global market by forming

ㆍ Joint development agreement on novel antibiotic drugs between Sanofi and PharmAbcine (Jan 2013), Joint company establishment for biological products manufacturing and promotion by Shinpoong and LFB (France) (Jan 2013), Joint development of biosimilar products by Samsung and Merck (Feb 2013), Joint company establishment for cell culture medium in SongDo by Genexine and Ajinomoto(Japan) (Apr 2013).

ㆍ Currently, Korea’s capability for developing biological products stands at 80% of the US. Although private pharmas are actively trying to commercialize their products in the market, until now, most of the support came from government However, investment from private sectors is expected to increase in the future.

ㆍ (Biosimilar and Biobetter products) Active development of a highly marketable biosimilars, additional investment in production facilities and expanded development of improved biobetters are being carried out by Korean pharmas.

- Ten companies are now developing biosimilar products and, nine companies are developing biobetter products.

- Decisive investment in manufacturing facilities allowed the Korea to become one of the world’s top 3 countries for biologics production (46 items from 15 companies for biosimilar and biobetter products)

ㆍ (Antibody products) Most of the Korean antibody products have entered the preclinical trials. There also have been several cases of technology transfer at development stage.

- 9 items from 9 companies

- (ADC, Antibody Drug Conjugate) Legochem transferred the related source technology to Green Cross (2012)

- (Double targeted antibody) entered into the basic research and preclinical trials

- (Immunotherapeutic antibody) new immunotherapeutic antibodies are under development through collaboration between ANRT and Paik Hospital

ㆍ (Stem cell therapy) Launch of 4 stem cell products and embryonic stem cell products, which are now going through clinical trials have all contributed to boosting development of new stem cell therapy in Korea.

- 24 items from 9 companies* Currently approved stem cell products: Hearticellgram-AMI (Pharmicell, 2011) Cartistem

(Medipost, 2012) Cupistem (Anterogen, 2012) Neuronata-R (Corestem, 2014)

* The CHA hospital group (CHA biotech co.) built strategic partnership with ACT (USA) -> USA, GB and Korea started clinical trials and presented trial results regarding eye sight improvement and retinal epithelial cell engraftment. Also they developed the drug for macular degeneration

ㆍ‌‌(Tissue regeneration) Korean biopharmas succeeded in commercialization of engraftment techniques by developing diverse tissue regeneration materials and supporters.* Cartilage regeneration: Sewon Cellontech developed and commercialized Cartifil, which

are made up of highly purified collagen and firin.

* 3D Printing: Prof. Cho Dong-Woo (Pohang University of Science and Technology) et al., developed supporting system using CAD/CAM and photopolymerization technique.

ㆍ‌‌ (Immune cell therapy) Eight items using T cell, NK cell and dendritic cells have entered clinical trials.

ㆍ‌‌(Gene therapy products) Thirty-nine items from 12 companies are now under clinical trials.

- Kolon Life Science has completed clinical trials of an osteoarthritis drug and is expected to get an approval in 2016.

ㆍ (3D Printing) Korean biopharmas have developed biosupporters for the use in human tissue regeneration

- T&R biofab, CGbio : Companies developeda biodegradable medical materials using 3D

printing.Regenerative medical techniques based on tissue engineering was developed by, highly qualified convergence technology enterprise

ㆍ (Biomarker)

- Korean companies developed products for tailored therapy in its attempt to respond to a post genome era.

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Development Status of Biological Products2

Korea Biomedicine Industry Association Status of BiopharmaceuticalIndustry in Korea

- CBSBioscience: developed the first drug repositioning technique in Korea, Develop new antitumor agent based on biomarkers

* In the US, it is mandatory to use biomarkers for targeted antitumor agent when seeking approval for clinical trials and launching. (Jun 2014)

Annex1 | Status of Biosimilar/Better Development in Korea

CompanyProduct name (Code name)

Comparator (constituent)

Indication Phase

Samsung Bioepis SB5

Humira

Rheumatoid arthritis 3

LG Life Sciences LBAL Healthy volunteer 1

Bio C&D BCD100 Healthy volunteer 1

Schnell Life Sciences GS071Remicade


Samsung Bioepis SB2 Rheumatoid arthritis 3

LG Life Sciences LBEC0101Enbrel

Healthy volunteer 1


DaewoongPharmaceutical co.

DWP422 Healthy volunteer 1

Samsung Electronics SAIT101

Mabthera

Non Hodgkin’s lymphoma 1


Celltrion CT-P10Follicular lymphoma 3


Samsung Bioepis SB3 Herceptin Breast ca. 3

Chongkeundang CKD-11101Nesp

Chronic renal failure, anemia 3

CJ Cheil Jedang CJ-40001 Healthy volunteer 1

PanGen PDA10 Eprex Chronic renal failure, anemia 3

Annex2 | Status of Antibody Product Development

Category Company Technology Development status

ADC Legochem

Next generation resource technology, overcoming

previous ADC technology by using an unique linker

Green Cross and Neopharm collaborates for

preclinical investigation.

Category Company Technology Development status

HanwhaDevelop independent conjugation technique

Three pipelines are in discovery stage

AlteogenDevelop a linker specifically

conjugated the drug to antibody

Discovery stage

CelltrionDevelop Dolastin10 derivatives as a drug binding to antibody

Discovery stage

ANRTDevelop new antibody for

ADC, based on fully humanized antibody library technique

Discovery stage, Collaborates with Asan Medical Center

Double targeted antibody

ANRTHumanized antibody specified

to ANFA and IP10

Preclinical stage, Seoul National University,

Metabolab and KRIBB collabolate

HanwhaHumanized antibody targeting

VEGFR2 and DLL4 Pre-clinical stage

PharmAbcine DIG-KT, PIG-KM Discovery

Immunotherapy antibody

ANRTHumanized antibody targeting

new immune check pointDiscovery stage, Collaborates

with Busan Baik Hospital

Annex3 | Status of Stem Cell Therapy Development

Company Product Category Target disease Phase

Pharmicell

MSC1 Auto Bone marrow derived mesenchymal stem cell

Acute cerebral infarction

3

Cerecellgram-spine

AutoBone marrow derived

mesenchymal stem cell Chronic spinal

cord injury2/3

Livercellgram AutoBone marrow derived

mesenchymal stem cellLiver chirrhosis 2

Hearticellgram-AMI


mesenchymal stem cell Acute myocardial

infarction3

Kstemcell (previous RNL life

science)

Bascostem AutoAdipose cell derived

stem cellBuerger’s disease

1/2(Completed)

RNL-Astrostem AutoAdipose cell derived

stem cellSpinal cord injury 1/2

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ANL-Jointstem AutoAdipose cell derived

stem cellDegenerative

arthritis1/2

(Completed)

Jointstem-Allo Allo Adipose cell derived

stem cellOsteoarthritis 1

Anterogen

ANT-SM AutoAdipose cell derived

stem cellFecal incontinence

1

ANTG-ASC AutoAdipose cell derived

stem cellComplex anal

fissure2

ALLO-ASC AlloAdipose cell derived

stem cellFistula from

Crohn’s disease1/2a

ALLO-ASC-TI AlloAdipose cell derived

stem cellTennis elbow (Epicondylitis)

1/2

Medipost

Promostem AlloCord blood derived

mesenchymal stem cell

Support an unrelated

hemopoietic stem cell transplantation

1/2

Pneumostem AlloCord blood derived

mesenchymal stem cell

Premature bronchopulmonary

dysplasia2

Neurostem AlloCord blood derived

mesenchymal stem cell Alzheimer’s

dementia1/2a

Homeotherapy Homeo-GH AlloBone marrow derived

stem cellGVHD

1(Completed)

Corestem

HYNR-CSHYNR-CS inj


stem cellALS

1/2(Completed)

HYNR-CS-AlloHYNR-CS-Allo inj

AlloBone marrow derived

stem cellALS 1

BRICKangstembiotech

Cord blood derived

mesenchymal stem cell therapy

AlloCord blood derived

mesenchymal stem cellLeg ischemia 1

Purestem-AD inj AlloCord blood derived

mesenchymal stem cell Atopic dermatitis 1/2a

Purestem-CD inj AlloCord blood derived

mesenchymal stem cellCrohn’s disease 1/2a


Purestem-RA inj AlloCord blood derived

mesenchymal stem cell Rheumatoid

arthritis 1

CHA bio and Diostech

hES-RPE Allo Embryogenic stem cell derived retina epithelial

cellStargardt disease 1

hES-RPE Allo Embryogenic stem cell derived retina epithelial

cell

Senile dryform AMD

1/2a

Annex4 | Status of Gene Therapy Development

Company Product Target disease Phase

Pusan National University JX-594 Renal cell carcinoma 2a

Kolon Life Science Tissuegene-C Degenerative arthritis 3

Astellas Pharma Global Development Inc.

ASP0113 Inj.Seropositive recipients undergoing

HCT (Hematopoietic Cell Transplant)

3

VGX Internationals VGX-6150 Chronic Hepatitis B 1Genexine HB-110 Chronic Hepatitis B 2a

Oncolys Biopharm Inc. Telomerlycin HCC 1/2

National Cancer CenterRecombinant Adenovirus

Colon cancer with hepatic metastasis, Gastric cancer with

hepatic metastasis1

Dong-A University HospitalRecombinant Adenovirus

Advanced HCC 1

Quintiles Telomerlycin HCC 1

Genexine GX-188E Premalignancy of Cervix (CIN3)

Long-term follow up

observations from completed

phase 2

Genexine GX-051 Head and neck cancer 1/2

Shillajen SJ-103β Hepatic carcinoma 1

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WHO Prequalification(WHO-PQ) Products

WHO Prequalification(WHO-PQ) Products

II

Product name Applicant Date of PQ

Medicines

MalariaArtesunate + Pyronaridine

tetraphosphate

Shin Poong Pharmaceutical Co,

LtdFEB 2012

Tuberculosis Cycloserine Dong-A ST Co, Ltd NOV 2012

Vaccines

Polyvalent vaccine

Polyvalent vaccine

Quinvaxem in cPADBerna Biotech Korea

CorporationSEP 2006

Euforvac-Hib LG Life Sciences AUG 2012

Hepatitis B

Hepavax-GeneBerna Biotech Korea

Corporation

MAR 2004

Hepavax-Gene TF JUL 2012

Euvax B LG Life Sciences NOV 1996

Product name Applicant Date of PQ

Influenza (Seasonal)

GC FLU Multi

Green Cross Corporation

NOV 2012

GC FLU APR 2011

Influenza A (H1N1)

Green Flu-S MAY 2015

in vitro diagnostics

Malaria RDT

SD BIOLINE Malaria Ag P.f/P.v

StandardDiagnostics

2015

SD BIOLINE Malaria Ag P.f 2015

SD BIOLINE Malaria Ag P.f FEB 2010

SD BIOLINE Malaria Ag P.f/Pan JUL 2013

HIV RDTSD BIOLINE HIV-1/2 3.0 MAR 2013

SD Bioline HIV Ag/Ab Combo MAY 2013

* Sources : WHO, 2015

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IIICompany Introduction

Anterogen Co., LtdBioneer CorporationBoryung Pharmaceutical co., LtdCelltrion, Inc.CJ HealthCare Corp.Daewoong Pharmaceutical Co., LtdGeneOne Life Science, Inc.Genexine, Inc.Green Cross Corp.HanAll BioPharma Co. Ltd.HugelIL-YANG PHARMACEUTICAL CO., LTD.ISU Abxis Co., Ltd.GemVax & KAEL Co., Ltd.Kolon Life Science, Inc.LG Life Sciences, Ltd.MEDIPOST Co., LtdMedytoxSamsung BiologicsSamyang Biopharmaceuticals Corporation.Sewon Cellontech Co., Ltd.SK Chemicals Co. Ltd.Tego Science, Inc.ViroMed. Co., Ltd.

Company Introduction

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CEOSung Koo Lee

Location(Namsung Plaza, Gasan-dong) 405, 130, Digital-ro, Geumcheon-gu, Seoul, South Korea

Homepage

http://anterogen.com/main/en/

Anterogen Co., Ltd

Anterogen is a leading pharmaceutical company for adipose-derived stem cell technology

Anterogen is a leading pharmaceutical company for stem cell research and development. The main objective is to develop a unique stem cell therapy for intractable, rare, and degenerative diseases that cannot be treated with current medical treatments.Anterogen was established in 2000 as a biopharmaceutical company, focusing on development of adult stem cell therapy. Anterogen was the first company within South Korea to research for commercialization of adipose-derived stem cells.Moreover, Anterogen licensed stem cell technology to overseas in 2004, and established a GMP factory in 2006 for production of all stem cell therapy products in sales and clinical trials field.Anterogen has a potential technology to overcome limitations in stem cell therapies. Our future objective is to become a world-class stem cell pharmaceutical company in global market by expanding the field of stem cell therapy in intractable and degenerative diseases, and provide a breakthrough in today’s medical treatments.

ProductsCupistem® is the world’s first registered product as autologous adipose-derived stem cells. Cupistem®’s immunosuppressive effects with wound repair abilities are highly effective for treatment of Complex Crohn’s fistula. In clinical trials, 82% of patients with complex Crohn’s Fistula observed healing effects after 8 weeks from treatment with good tolerance, and long term observation showed 88% of fistulae remain sealed after 12 months from treatment. 83% of fistulae closed after 24 months from treatment.Despite complex Crohn’s Fistula is difficult to treat with standard therapies, Cupistem® showed its efficacy without any harm on sphincter muscles.* Reference : Ce l l Transp lant . 2013;22(2) :279-85, S tem Ce l l s. 2013

Nov;31(11):2575-81, Stem Cells Transl Med. 2015 May;4(5):532-7

Product ImageProduct Name Classification Applications

Cupistem® ETC, orphan drugAutologous adipose-derived

mesenchymal cells for treatment of Crohn’s fisulta

SCM2 cosmeticsPromotes skin regeneration after laser or MTS therapy.

Therastem Derma

cosmeticsHome-care use for skin

regeneration after laser of MTS therapy.

Stem Cell Media

Program Setcosmetics

Skin care products for home-care and professionals.

R&D Pipeline

Cell type Project IndicationDevelopment

StageAutologous adipose-derived mesenchymal

stem cellsCupistem

Complex Crohn’s Fistula

Registered, available on

market

Allogeneic mesenchymal stem cell

sheet

ALLO-ASC-DFU Diabetic Foot Ulcer Phase II

ALLO-ASC-BI Burn Injury Phase II

ALLO-ASC-EBDystrophic

Epidermolysis Bullosa

Phase I

Allogeneic adipose-derived mesenchymal

stem cells

ALLO-ASC-TI Tendon Injury Phase II

ALLO-ASC-CD Crohn’s Disease Phase I


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CEOHan-Oh Park, Ph.D.

Location49-3, Munpyeong-dong, Daedeok-gu, Daejeon 306-220, Korea

Homepagewww.bioneer.com

Bioneer Corporation

Leadership in RNAi Therapeutics

ABioneer 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 fullyintegrate 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.

SAMiRNA™ TechnologySAMiRNA (Self-Assembled-Micelle-inhibitory-RNA) is a novel class of RNAi molecule, developed by Bioneer, which allows efficient and safe in vivo delivery of siRNA to target tissues. SAMiRNA is a SCE (single Chemical Entity), which is manufactured using a proprietary process 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. Other advantages of SAMiRNA include its flexibility to incorporate siRNA sequences against any disease target, as well as enhancement of its therapeutic potential as a delivery platform through the use of cell-type specific targeting ligands. 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’s-best 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 ensure top-quality products and services to meet your unique needs.

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


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CEOHan-Oh Park, Ph.D.

Location49-3, Munpyeong-dong, Daedeok-gu, Daejeon 306-220, Korea

Homepagewww.bioneer.com

Boryung Pharmaceutical co., Ltd.

Total Healthcare Company Contributing to the Human Health

Boryung Pharmaceutical company (here after Boryung), since founded in 1963, has been trying its best to contribute to the health and well-being of humanity with corporate mission to ‘realize mutual health and coprosperity based on human centered values’.Boryung has invested continually on research and development and made continuous efforts to produce highquality products in the specialty areas such as cardiovascular, antineoplastic and antibiotics drugs. As a result, our products such as Gelfos M, Yongkaksan and Kyushin have become the best selling products and Boryung has emerged as the most familiar and trusted brand in Korea.

R&D pipeline

Category Product RS PC PI PII PIII RG Launch

Biologics

VaccineBVN 001

○

VaccineBVN 002

○

VaccineBVN 003

○

Liver Cancer

BCB 002

○


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celltrion Inc

CEOJungJin Seo

Location13-6, Songdo-dong, Yeonsu-gu, Incheon, 406-840, South Korea

Homepagewww.celltrion.com

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 accu-mulated R&D technology and manufacturing capabilities to develop, man-ufacture and market 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.

Productsemsima™ (infliximab) is the world’s first biosimilar mAb to receive pos-itive opinion from an advanced and developed nations’ regulatory body, which is a monoclonal antibody against tumor necrosis factor alpha (TNF-α) used to treat autoimmune diseases like ankylosing spondylitis, rheumatoid arthritis, Crohn’s Disease, ulcerative colitis, psoriasis and psoriatic arthritis. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had given positive opin-ion for Celltrion-developed Remsima™ for sale in the European Union (EU) in June 2013. With this positive CHMP opinion, Celltrion is per-mitted to obtain marketing authorization approval (MAA) from 27 EU countries and 3 EEA (European Economic Area) countries (for a total of 30 countries) through simple administrative procedures. Remsima has already received approval from the MFDS (former KFDA) in July, 2012.Global launch of Remsima™ is remarkably good news for patients who pre-viously had limited access to advanced therapeutics, in particular, those hin-dered by the high cost of antibody biopharmaceuticals. We believe that the first biosimilar mAb approval by the EMA will spearhead the start of a new era of biosimilar mAbs in the pharmaceutical industry. Celltrion, Inc. also 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 PipelineCelltrion 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 and completed submission for approval in Korea.

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 drug (PROJECT CT-P27) to overcome the limitations of existing vaccines and synthetic drugs for pandemic or seasonal influenza viruses. Celltrion received IND approval from England’s Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a phase 1 clinical trial for CT-P27, an influenza antibody shown to have efficacy for pandemic and seasonal flu strains, includ-ing various subtypes of 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 variationsof influenza viruses. Thus, this new drug is expected to become the world’s first comprehensive influenza virus treatment antibody, if succeed-ed.Additionally, Celltrion is developing innovative drug to cure rabies by collaborrating 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 sub-stances. Celltrion’s broad innovative drug pipeline is expected to serve as the driving force behind Celltrion’s future growth.


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CJ HealthCare Corp.

CEODal won Kwak, Chul ha Kim

LocationCJ CheilJedang Center, 330, Dongho-ro, Jung-gu, Seoul 100-400, Korea

Homepagewww.cjp.co.kr

Heal the World, Better Life

CJ HealthCare started its business as Pharmaceuticals Business Unit at CJ CheilJedang Corporation from 1984.In line with CJ’s corporate vision, CJ HealthCare has been striving for making people healthier, happier and better convenient with innovative and differentiated pharmaceutical products. As of 1 st April, 2014, CJ HealthCare was spun off from CJ CheilJedang Corporation and became a separate pharmaceutical corporate entity with purpose of enhance-ment of expertise in pharmaceutical business to grow globally.CJ HealthCare has become a representative Korean pharmaceutical company in promising therapeutic areas such as oncology, cardiology, endocrinology and nephrology. CJ HealthCare is working hard to grow globally, focusing on rapidly growing China and Southeast Asian mar-kets as well as highly-regulated but attractive Japan and EU markets. Through our newly established cGMP compliant plant in Osong, CJ HealthCare can secure global standard manufacturing facilities and op-eration capabilities.CJ HealthCare will make its best efforts to jump into a leading position among global pharmaceutical companies.

ProductsProduct Details

1. Epokine Inj. (rh-EPO)Epokine ® was developed 1st in Korea and 3rd in the

world. Epokine ® is safe and effective in treating anemia of hemodialysis patients with end-stage renal disease.

2. Leukokine Inj. (rh- G-CSF)

Chemotherapy in advanced cancer patients and in acute Leukemia patients can cause the Neutropenia. Leukokine

® can help to support their natural defenses during strong chemotherapy.

R&D PipelinePipeline Description DS PC PI PII PIII NDA

CJ-40001 Anemia ○

Hand-Foot-Mouth Disease vaccine

Hand-Foot-Mouth Disease

○

LUCENTIS Biosimilar Retinopathy ○


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Daewoong Pharmaceutical Co., Ltd.

CEOLee, Jong Wook

Location163-3, Samsung-dong,Kangnam-gu, Seoul,Korea

Homepagewww.daewoong.com

Daewoong Pharmaceutical is the pharmaceutical company with the No. 1 sales of prescription drugs in the Korean market.

Established in 1945 in Seoul, South Korea, Daewoong Pharmaceutical offers high-quality and innovative pharmaceutical products and is one of the top market leaders in Korea.For over 60 years, Daewoong Pharmaceutical has been providing better health for people through its total dedication to healthcare. Daewoong has built strong core competency for new drug development to meet diverse medical needs and enhance human life.Building on our core strength, Daewoong Pharmaceutical has involved in becoming a global healthcare group by operating our foreign branch-es in SE Asia and by collaborating with global partners. We have an inspiring mission to become a top 50 global healthcare company which contributes to improving the quality of life for people worldwide.The reinforcement of the R&D capacities through the establishment of R&D center in the USA, China and India.Daewoong Lifescience Research Institute has been focused on devel-oping new chemical entities, biologics, incrementally modified drugs and high-value added APIs. Daewoong has also been studying to find solutions for the unmet therapeutic needs of neuropathic pain disease, Alzheimer’s disease as well as other innovative programs like anticancer gene therapy. Daewoong is operating several overseas offices in China, Vietnam, Indonesia, Thailand, Philippines, USA, and India and has R&D centers in China, India and America.

R&D Pipeline


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CEOYoung K. Park

Location223 Teheran-Ro, Suite 1903, Gangnam-Gu, Seoul, Korea

Homepagewww.genels.com

HomepageMoonsup JEONG (Director/Pharma R&D Division), ([email protected], +82-2-557-6784)

GeneOne Life Science, Inc.

GeneOne Life Science, Inc. is a biopharmaceutical R&D company dedicated to the development and contract manufacturing of plasmid-based biomedicines, including DNA vaccines.

With exclusive rights to use core technologies of DNA design and in

vivo delivery that are critical in development of gene-based biomedi-

cines – including DNA vaccines – GeneOne Life Science, Inc. is distin-

guished from most global competitors that use partial technologies.

The company is recognized as a global leading company in this field

with advanced technologies and patents in manufacturing of DNA

vaccines and plasmid medicines and wholly owns an international-

ly-recognized plasmid contract manufacturing organization (CMO)

called VGXI, Inc. that satisfies international standards for clinical

pharmaceutical products.

R&D Pipeline

mailto:[email protected]


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Genexine, Inc.

CEOYoung Chul Sung, Ph.D

Location700 Daewangpangyo-ro, Korea Bio Park Bldg. B, Bundang-gu, Seongnam-si, Gyeonggi-do 463-400, South Korea

Homepagehttp://genexine.com

Genexine, Inc. is a leading biotechnology company

specializing in immunotherapeutics, based on its

strong immunology expertise and R&D capabilities.

Founded in 1999, Genexine consists of about hundred employees, half of which are scientists with MSc or PhD. Genexine is located in Korea Bio Park, Pangyo Techno Valley near Seoul, Korea.

Platform Technology

1) hyFc technology – next generation half-life extension technology

Genexine creatively invented hybrid Fc fusion half-life extension technology that enables long-acting protein therapeutics with well-balanced benefit of efficacy, safety, convenience, cost-efficiency as well as substantially low risk of immunogenicity.

2) therapeutic DNA vaccine technology for infectious diseases and cancerThrough long h is tory o f DNA vacc ine R&D, Genex ine has accumulated extensive technology and know-how of therapeutic DNA vaccines against viruses such as HPV, HBV, TB, etc. DNA vaccine induces robust antigen-specific immune response against infected cells or cancer.Based on proprietary innovative platform technology, Genexine has developed various products in preclinical and clinical-stages. Genexine’s major clinical pipelines are GX-H9 (long-acting hGH-hyFc) in Phase II in EU and Korea and GX-188E (therapeutic HPV DNA vaccine) in Phase II in EU and Korea. In pre-clinical stage, Genexine has GX-P2 (PD-L1-hyFc as a PD-1 agonist) for autoimmune diseases, GX-I7 (IL-7-hyFc), GX-F7 (long-acting Factor VII-hyFc), etc.

R&D Pipeline

1) GX-H9 (Long-acting hGH-hyFc): Long-acting human growth hormone (hGH) genetically fused with Genexine’s proprietary hybrid Fc (hyFc) platform. The first in human trial has been completed in EU and currently a multinational AGHD patient phase 2 clinical study is being conducted in EU and Korea. In phase I clinical trial, no SAEs and ADA formation were reported, and dose-dependent PK and PD (IGF-1 level) profiles were demonstrated. GX-H9 is targeting pediatric and adult growth hormone deficiency patients with weekly and semi-monthly administration and being co-developed with Handok Pharmaceuticals.

2) GX-188E (HPV therapeutic DNA vaccine): HPV therapeutic DNA vaccine for Cervical Intraepithelial Neoplasia (CIN) / Cervical Dysplasia in Phase II clinical trial. GX-188E has the potential to induce complete regression from high grade Cervical Intraepithelial Neoplasia caused by high-risk types of HPV16/18 infection. In Phase I clinical trial, Genexine demonstrated that electroporation(Ichor Medical Systems)-enhanced immunization with a rationally designed HPV DNA vaccine (GX-188E), preferentially targeting HPV antigens to dendritic cells, elicits a significant E6/E7-specific IFN-γ-producing T-cell response in all nine cervical intraepithelial neoplasia 3 (CIN3) patients. Seven out of nine patients displayed complete regression of their CIN3 lesions and viral clearance and exhibited an enhanced polyfunctional antigen-specific CD8 T-cell response within 36 weeks of follow up. These results were recently published in Nature Communications (Kim et al., Nature Comm., 2014; 5,5317).

3) GX-P2 (PD-L1-hyFc as a PD-1 agonist): GX-P2 is PD-L1-hyFc as a PD-1 agonist, which is a first-in-class drug candidate in preclinical stage for autoimmune diseases. It is based on our innovative long-acting hyFc technology (next generation Fc fusion technology). GX-P2 is designed to induce T-cell tolerance by targeting PD-1 and/or B7.1 and able to regulate uncontrolled T-cell activation or proliferation in autoimmune diseases. We confirmed animal PoC in inflammatory bowel disease (IBD) and published the results in Gut journal (Song et al., Gut, 2015; 64(2):260-271).


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Green Cross Corp.

CEOIl-Sup, Huh

Location303 Bojeong-dong,Giheung-gu, Yongin, Korea

Homepagewww.greencross.com

Development of Medications That Are Difficult to Produce but Necessary

Green Cross is an exemplary R&D-oriented company that leads the bio-technology 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 an-tibodies. GCC has been well known for the R&D and commercialization of ‘Hepavax™ B’, a world’s biggest selling hepatitis B vaccine, ‘Hantavax™ ’, a world’s first epidemic hemorrhagic fever vaccine, and ‘Suduvax™’, a world’s second chicken pox vaccine. A complete flu pipeline includes seasonal flu vaccine (GCFLU TM ), H1N1 vaccine, avian flu vaccine and etc. GCC is also pursuing opportunities in rare diseases developing therapies for Hunter syndrome (Hunterase™) and Fabry disease (GC1119). With contin-uous 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 3 rd largest Korean pharmaceutical company and invested $51.7 million in R&D which is one of the highest in Korea.

ProductsPlasma Fractions & RecombinantsStarting from the nation’s first Albumin production in 1971, Green Cross currently manufactures more than 12 plasma fractions including immu-noglobulin, anti-hemophilic factors, and anti-thrombin factor. Recent innovations include ‘BDD rhFVIII (GreenGene TM F)’, a 3 rd Generation of recombinant Factor VIII for hemophilia A treatment.

VaccinesWe 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 Flu TM became the fourth in the world to ob-tain PQ (Pre-Qualification) approval from the WHO.

R&D Pipeline


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HanAll BioPharma Co. Ltd.

CEODr. Sungwuk Kim, Dr. Seungkook Park

Location11-10 Sincheon-dong, Songpa-gu, Seoul, Korea

Homepagewww.hanallbiopharma.com

nnovative Medicines to Improve the Quality of Human Life

HanAll BioPharma is a R&D-oriented pharmaceutical company, currently listed on the Korean Stock Exchange (KOSPI).

R&D Pilpeline

Product Information

HL156CAN

HL156Can, a mitochondrial primer, is a New

Chemical Entity (NCE) targeting cancer

metabolism, inhibiting mitochondrial OXPHOS

system. This inhibition leads to ATP depletion,

which increases metabolic stress in cancer

cells. HL156Can exhibits cytotoxic effect in

cancer cells with defected AMPK signaling

function and cytostatic effect in cancer cells

with normal AMPK signaling function. HanAll

has confirmed potential efficacy of HL156Can

to overcome resistance in number of selected

cell lines. Currently, HanAll is conducting in-vivo

experiments with LKB1 -/- (NSCLC) xenograft

model, Braf V600E inhibitor resistant melanoma

xenograft model, and lapatinib resistant

xenograft model.

HL036

HL036 is TNF-alpha receptor fragment for the treatment of local inflammatory diseases caused by TNFalpha such as uveitis, dry eyes, and AMD. Current systemic anti-TNF drugs’ limitations include small volume of distribution and adverse drug events due to high dosage. Therefore, by utilizing fragment, HanAll’s TNF receptor fragment will have greater volume of distribution when administered topically compared to currently marketed anti-TNF-alpha products having larger molecular size. Furthermore, via protein engineering, HL036 will have greater affinity to allow smaller doses and increase the efficacy.It is anticipated that higher concentrations of HL036 will be found in targeted ocular areas when administered topically, preventing systemic ADEs. HanAll aims to utilize this unique property of HL036 for the indication of dry eyes by developing ophthalmic solution.

HL161

HanAll is currently developing fully human monoclonal antibodies targeting the Fc Neonatal Receptor (FcRn) for the treatment of autoimmune diseases 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.Hence, HL161 will reduce overall concentration of IgG by blocking FcRn, leading to reduced levels of pathogenic IgG.

HL009

HL009, adenosylcobalamin liposomal gel, has 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.Adenosylcobalamin has low permeability through skin due to its large molecular size and relatively high hydrophilicity. Thus, HanAll has formulated adenosylcobalamin topical product utilizing liposomal formulation technology. Benefits of liposomal formulation technology include improved stability, enhanced skin penetration due to increased lipophilicity, and reduced skin irritation by using lipids with proven safety.

HL040

HL040, a fixed dose combination product, is composed of atorvastatin and losartan for the treatment of hyperlipidemia and hypertension. HanAll finished the phase I study, and currently conducting phase III trial in Korea and phase I study in US.


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Hugel

CEOKyeong Yeop Moon

Location61-20, Sinbuk-ro, Sinbuk-eup, Chuncheon-si, Gangwon-do, 24206, Korea

Homepagewww.hugel.co.kr

Hugel Inc. was established in 2001 aiming to improve the quality of humans’ blissful lives by providing “healthy and long-lasting beauty to human kind”

Hugel Inc. developed biological product “Botulax” using botulinum tox-in and gained 40% of market share in Korea. Since 2009, we have been exporting “Botulax” to 19 countries including Asia, such as Japan, Thai-land, Philippine and etc., and South America, such as Peru, Paraguay, Bolivia, Chile, Columbia, Ecuador, and etc. In more than 30 countries, the registration including clinical trials is in progress, expecting to get approval for Russia in 2016, China and Eu-rope in 2018, the United States in 2019. In order to ensure the increas-ing market demand, the second plant with cGMP standards has been completed and will be operated from 2016. In 2014, we launched ‘The Chaum’ which is a filler product, the most popularly used in plastic surgery and cosmetic field along with botu-linum toxin. Also, we accelerate our growth by introducing facial lifting product (Blue Rose), cosmeceutical (Wellage), and etc. to create synergy effect with existing products. We, Hugel Inc., try to grow as an interna-tional specialty pharmaceutical company that continuously research and develop pharmaceutical products in various markets including indication expansion of botulinum toxin, scar treatment development and etc.


BotulaxInjection (Botulinum Toxin Type A)

There are three product types, 50, 100, and 200 units, per vial. The ap-proved indications are blepharospasm and glabellar line improvement, and will be expanded to post stroke upper limb spasticity and pediatric cerebral palsy. Currently, expansion of the range of treatment such as hyperhidrosis, painless liquid product, non-animal origin products, and

etc. are under development.The Chaeum ( Crosslinked hyaluronicacid)

It is a low-pain hyaluronic acid product containing lidocaine and consisted of four types, No.1, No. 2, No. 3 and No. 4, according to its

viscoelasticity. The Chaeum is provided with a dedicated injection cartridge which considers the convenient injection and patients’ safety. It functions as temporary facial wrinkle improvement and tissue resto-

ration.Wellage(Cosmetics)

It is a skin cosmetic line enhancing moisturizing and antioxidant functions, being consisted of ‘Vital Neo Water-Lock-Toner’, ‘Enrich Emulsion’, and ‘Nutritious Rich Cream’. This bio-cosmetic, Wellage,

provides proper cares per each skin type as cosmeceuticals with use of key ingredients such as nero-peptide, melatoine and plant-based stem

cell extractions. Bluerose(Facial tissue fixing thread)

It is a facial fixing thread having Polydioxanone as main ingredient. It is absorbable in human body as medical thread for facial tissue fixing, which has skin lifting effect by barbs around the thread when inserted

to loosen or dented parts caused by facial tissue loss and etc.

R&D PilpelinePipeline Description DS PC PⅠ PⅡ PⅢ NDA

BMT101siRNA products to prevent

and inhibit intractable hypertrophic scar

○

Botulax(Botulinum neurotoxin

Type A)

Dynamic equinus foot deformity in children with

cerebral palsy○

Post stroke upper limb spasticity

○

Hyperhidrosis ○

Painless liquid product development

○


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IL-YANG PHARMACEUTICAL CO., LTD.

CEODONG YEON, KIM

LocationIL-YANG BLDG. 194 Dogok-ro, Gangnam-gu, Seoul, Korea

Homepagewww.ilyang.co.kr

Respect Humanity, Promote Human’s Health, Improve Welfare

IL-YANG Pharmaceutical Co., Ltd. has been exerting its intended efforts to manufacture superior pharmaceutical products for the last half a century and it is still going on. Since it took the first step to supply pharmaceutical products in Korea, since 1946, IL-YANG has been advancing into a top-ranking pharmaceutical company in the world with developing in the area of Gastrointestinal, Hematology, Vaccine, and Virology. IL-YANG established vaccine plant in April 2011 with production capacity of 60mil doses per year. IL-YANG has been exporting a variety of pharmaceuticals to approximately 30 countries including USA and Europe. IL-YANG established two branches in China, YANGZHOU IL-YANG PHARM. Co., Ltd. and TONGHUA IL-YANG HEALTH PRODUCTS Co., Ltd. for manufacturing and distribution of finished pharmaceuticals in China. Since their establishment, the sales and business are expanding enormously. In Sept. 2014, YANGZHOU IL-YANG had completion ceremony for newly built cGMP plant which is compliance to EU-GMP standard.

ProductsIL-Yang Flu Vaccine INJ.1) Purified inactivated trivalent influenza split vaccine (Vial & Prefilled

syringe)2) Thimerosal-free & preservative-free product (fertilized embryo based)

3) Indication: Prevention of influenza for persons above 6 months4) Development stage: - WHO Prequalification submitted on JAN, 2015 - BLA approval on 8th AUG, 2013 in Republic of KOREA5) Key features - The IL-YANG Inactivated Split Influenza Vaccine showed HI antibody met the US FDA guideline for both age groups, the 6 month to < 18 year age group (Children) and the ≥ 18 year age group (Adults) - The long-term safety assessments showed low frequency serious adverse events

R&D Pilpeline


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ISU Abxis Co., Ltd.

CEODaeseong Kim

LocationGlobal R&D Center C-5F, 22 Daewangpangyo-ro, 712beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, 13488, Korea

Homepagewww.abxis.com

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

ISU Abxis is the leading Korean biopharmaceutical company which succeeds in development on the first therapeutic antibody in Korea. ISU Abxis provides the world-class products to MENA and Latin America region and continues to expand its business portfolio by collaboration with the US and EU based pharmaceutical companies. Since 2001, ISU Abxis has established its own platform technologies and product pipelines with a desire of being an axis of all therapeutic antibody industry as its name stands (ABXIS=AntiBody + aXIS). Begin-ning with the successful development and market-launch of ISU’s first therapeutic antibody in 2006, ISU Abxis has led Korean biopharmaceu-tical industry specialized in biosimilars and biobetters. Consequently in 2013 and 2014, ISU Abxis launched two biotherapeutics for orphan dis-eases of Gaucher and Fabry. ISU Abxis has accumulated the world class manufacturing and QC/QA management through the full development and manufacturing experiences in the globally harmonized compliance.ISU’s three products, supplied to around 30 countries including Turkey, India, Algeria and Venezuela, are available as the only alternative against the originator in the world. Furthermore, ISU Abxis operates the mammalian production dedicated cGMP facility as obtained the GMP certificates from Turkey, Brazil, Colombia and a number of major coun-tries in Latin America and Middle East.Now ISU Abxis also makes its great efforts in the development of novel biologics for the patients with cancer and hemophilia. Besides the inter-nal development activities, ISU Abxis recently does its best in importing and providing orphan drugs for Korean patients who suffer the lack of treatment option.ISU Abxis will grow its advanced technology based business for diffi-cult-to-treat and orphan disease market both domestically and world-wide

ISU’s excellent bio-technology expertise provides a global and local potential partner with (1) the higher productivity at CMO level (2-5g/L), (2) development management system enabling the first-in-human IND from the cell line development within 24 months, and (3) higher biosimilarity to its original product.


Clotinab (Abciximab)

- Indication: Adjunct to Percutaneous Coronary Intervention (PCI) - The first therapeutic antibody developed in Korea and the world’s second Abciximab - Launched in Korea in 2007 and exported to twelve countries including India, Turkey, Columbia, Venezuela and etc.

Abcertin (Imiglucerase)

- Indication: Enzyme Replacement Therapy (ERT) for Gaucher disease (GD) - The first drug for GD developed in Korea and the world’s second Imiglucerase - Launcher in Korea in 2013 and under the registration in around 20 countries

Fabagal (Agalsidase beta)

- Indication: Enzyme Replacement Therapy (ERT) for Fabry disease (FD) - The first drug for FD developed in Korea and the world’s second Agalsidase beta - Launched in Korea in 2014

Pheburane (Sodium phenylbutyrate)

- Indication: adjunctive therapy in the chronic management of urea cycle disorders - Imported product from EU (under the Korean registration)

R&D Pipeline


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GemVax & KAEL Co., Ltd.

CEOSang Jae Kim, Kyung Hee Kim

Location146 Unjung-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea

Homepagewww.gemvax.com

GemVax & KAEL Co., Ltd. is an innovative company dedicated to development, commercialization of anti-cancer vaccine, peptide vaccine and infectious disease DNA vaccine.

ProductsRIAVAX® (code name: GV1001)

RIAVAX is the “first-in-class” therapeutic vaccine for the treatment

of patients with pancreatic cancer. In September 15, 2014 Korean

Ministry of Food and Drug Safety (MFDS) granted RIAVAX marketing

and manufacturing authorization in Korea as a treatment of locally

advanced or metastatic pancreatic cancer patients whose serum

level is higher than 81.02pg/mL in combination with Gemcitabine/

Capecitabine.

RIAVAX is a peptide vaccine derived from human telomerase that is

abundantly expressed in most of human cancers. Briefly, the mechanism

by which RIAVAX kills cancer cells is to elicit combined CD4+/ CD8+

T cell responses, thereby inducing tumor eradication as well as long

term memory. The safety and efficacy/Immunogenicity of RIAVAX in

pancreatic cancer has been investigated and confirmed in number of

previous thirteen clinical trials. In a large-scale phase lll trial TeloVac,

the safety and immune-modulating effect of RIAVAX were confirmed

in over 1,000 patients. The key finding obtained from the TeloVac trial

was that RIAVAX markedly prolonged the survival in a group of patients

having high serum eotaxin level (>81.02pg/mL).

R&D pipeline


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Kolon LifeScience, Inc.

CEOLee, Woosok

LocationKolon Tower Annex, 13 Kolon-ro, Gwacheon-si, Gyeonggi-do, 427-709, Republic of Korea

Homepagewww.kolonls.com

Kolon Life Science, Inc. as a biotech company with gene and cell technical platform has been investing to R&D in the field of orthopedics, autoimmune disease, pain and cancer.

Invossa™ is the company’s first in-house developing product which is a single Intra-Articular (IA) injection based in cell-mediated gene therapy for the treatment of Osteoarthritis (OA) and which is currently in clinical phase 3 in both US and Korea. - The US trials have been being conduct-ed by its US entity, TissueGene, Inc.The company has been seeking for partners who are interested in com-mercialization and marketing of Invossa™ in their territory where the OA market is promising since no definite therapeutics have been so far while the product has a strong potential to be the first Disease Modify-ing OsteoArthritis Drug proven by clinical evidences.

PropositionThe advantages of Invossa™ over existing products satisfy the unmet medical needs of patients who have had no choice but to relying on only the extensive surgical interventions (i.e., total knee arthroplasty) following after enduring the pain taking oral anti-inflammatories or IA injections like Hyaluronic Acid and Steroid just for temporary symptom relief. The DMOAD profile which Invossa™ is targeting for is expected to fulfil the requirement from the patients who need to delay the dis-ease progression as long as possible in consideration of proper timing of surgical interventions which have limited shelf-life in their lifetime.Invossa™ was completed in clinical trial phase 2 in US and reached to the agreement with FDA through Special Protocol Assessment for phase 3 which is targeting to be entered in the first half of 2016. In Korea, phase 3 clinical trial was recently finished and its BLA is going to be submitted within 2015.

At this stage of the development, Kolon Life Science is eager to find partners who are interested in the collaboration opportunities for the product in the market of Latin America.(Licensing Opportunities) Commercialization including necessary clinical development and Sales/Marketing in the countries


Invossa™

A single intra-articular injection to knee joint provides with almost 2 years' long-term management of symptoms and delaying in disease

progression by anti-inflammation and structural improvement through re-establishing cartilage homeostatic balance in the OA knee joint

R&D Pipeline

Pipelines Description DS PC PI PII PIII NDA MKTLicensed Territory

KLS-2020

A gene therapy which blocks the signal of pain to the brain using a specific gene

○

KLS-3020

A therapy which attack and kill only cancer cells selectively without harming nor-mal cells consequently increasing the immune response to tumors.

○

http://www.kolonls.com


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LG Life Sciences, Ltd.

CEOIl-Jae Jung

LocationLG Gwanghwamun Bldg. 92, Sinmunno-2ga, Jongno-gu, Seoul, Korea

Homepagewww.lgls.com

The First Pioneer in Korean Pharmaceutical R&D Products

LG Life Sciences is Korea’s leading biopharmaceutical company. One of LG Group affi liate, 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 fi rst biosimilar approved by the EMEA and USFDA developed in Korea. LGLS is building a network of strategic alliances to extend its R&D and marketing reach.

ProductsProducts Details

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 Pipelines

* HA = Hyaluronic acid


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MEDIPOST Co., Ltd

CEOYang, Yoon Sun

Location21, Daewangpangyo-ro 644beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea

Homepagehttp://www.medi-post.co.kr

ContactErica Y Ryu General Manager, MEDIPOST America, Inc.Rockville, MD 20850Tel: +1 301 605 1087E-mail: [email protected]

MEDIPOST has ded icated i ts focus on biotechnology from its foundation in year 2000 until today, in spite of numerous adversities, rises and falls within the stem cell area.

As a result, MEDIPOST has become a front-runner in the field of the bio-pharmaceutical drug not only in Korea but also in the world. MEDIPOST with its state-of-the-art platform technology has led to the development and approval of the world’s first allogeneic stem cell therapy product – CARTISTEM.MEDIPOST continues its endeavors on clinical development and com-mercialization of stem cell therapeutics to improve quality of lives of many patients with intractable diseases not only in Korea, but also in the global markets.


CARTISTEM

• Stem Cell Therapy Product (Allogeneic umbilical cord blood-derived mesenchymal stem cells)

• Approved by MFDS Korea in January, 2012.• Indication: For the treatment of knee articular cartilage defects

in patients with osteoarthritis (ICRS grade IV) as a result of degenerative disease or repeated trauma.

Stem Cell Bank: Cord Blood Bank

Representative cord blood bank in Korea. Consistent No. 1 stem cell technology in Korea.The hematopoietic stem cells and other types of stem cells in cord blood are stored in cord blood bank and then supplied back when transplantation is needed for the treatment of diseases. The cord blood storage process of MEDIPOST is the current standard of cord blood banks in Korea and is globally recognized as well.

R&D Pipeline


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Medytox

CEOJung Hyun Ho

Location641-4 Gak-ri, Ochang-eup, Cheongwon-gun, Chungbuk 363-883, Korea

Homepagewww.medytox.com

Toxin, Filler and Even More

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.

ProductsProducts Details

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.

Hyaluronic AcidDermal 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 PipelineFueled 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.


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Samsung Biologics

CEOTae Han KIM (President & CEO)

Location125, Cheomdan-daero, Yeonsu-gu, Incheon, Korea 406-840

Homepagehttps://www.samsungbiologics.com

[email protected] : +82-32-455-3714Fax : +82-32-455-3825

Samsung BioLogics was established in April 2011 and is rapidly becoming a leader in the biopharmaceutical industry.

Our first two state-of-the-art, multi-product biologics facilities contain multiple production trains with separate suites for Upstream, Downstream and Fill & Finish, and a warehouse including long-term cold storage capacity.All production facilities are designed to meet the requirements of the U.S. FDA, EMA, and other global regulatory agencies. They are designed to allow for optimal flow of personnel, materials, samples, products, and waste, as well as, minimum product change-over time between batches. Through modular design, our filing suites can accommodate liquid fill, lyophilization unit production, labeling, primary and secondary packaging, as well as room for future expansion.Samsung’s Incheon bio-campus is truly a one-stop bio-manufacturing location capable of producing high quality bulk Drug Substance and Drug Product, thus delivering maximized customer satisfaction and convenience.

Products - Biopharmaceuticals CMOcGMP Manufacture of Drug Substance (DS) & Drug Product (DP)

Facility OverviewSamsung BioLogics facilities are located close to the Incheon Interna-tional Airport in Incheon, South Korea, and are built on a single 68 acre site, allowing for future expansion. The first two plants are designed to support mammalian production requirements and contain suites for upstream, downstream, fill & finish, an administration building, and a warehouse including, a significant volume long-term cold storage ca-pacity.

All plants are designed as multi-product facilities to meet the requirements of the U.S. FDA, EMA, and other global regulatory agencies. The layout allows for an optimal flow of personnel, materials, samples, product, and waste. The two facilities are optimized for minimum change-over time between batches, and the modular design of our filling suites seamlessly accommodates future expansions e.g. for pre-filled syringes, and additional liquid and lyophilization filling capacity. Samsung BioLogics’ facilities are capable of producing high quality bulk drug substances and drug products within the same facility – thus being a truly integrated to maximize customer satisfaction while minimizing potential product risks and costs. We are proud of our capabilities to deliver high quality products to our customers.

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CEOCheong-Ho Chang M.D.

Location8th FL. Wooyoung

Techno Center, 144 Achasan-ro,Seongdong-Gu, Seoul 133-831,

Korea

[email protected]

EC RepresentativeRMS INNOVATIONS (U.K)

LIMITED

Location310 Centennial Park, Elstree,

HertfordshireWD6 3TJ United Kingdom

[email protected]

Sewon CellontechCo., Ltd.

Samyang Biopharmaceuticals Corporation.

CEOTaeung Eom

Location31, Jong-ro 33-gil, Jongno-gu, Seoul, 110-725, Korea

Homepagewww.samyangbiopharm.com

Samyang Biopharmaceuticals Corporation, with its 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.

R&D Pipeline

CategoryTechnology Description

Products Development Status

API

Plant Cell Culture Paclitaxel Marketed

FermentationEpothilones Sirolimus

Pilot production Under development

Fermentation / Organic Synthesis

Liraglutide Under development

Organic Synthesis

Paclitaxel Docetaxel

Pemetrexed Bortezomib Cabazitaxel

Marketed Marketed Marketed

Pilot production Under development

Sewon Cellontech Co., Ltd., established in 1971, offers full-array of products through its three business divisions: Plant Equipment, Mechatronics System and RMS (Regenerative Medical System).

Since 1996, RMS has conducted comprehensive researches to identify the major key factors in the tissue regeneration. With the cutting-edge technologies, RMS has developed innovative products in the field of regenerative medicine and created two portfolios of products termed as RegenGraft (BioCollagen Scaffold) and Stem Cell System(Cell therapy). RMS’s mission is to design, develop and manufacture biocompatible therapeutic materials according to specific design criteria to meet diverse clinical needs. RMS has been dedicating in research to create a new concept for regenerative medicine industry and to deliver the optimized solution to clinicians throughout the world. Currently, RMS products are in the world-wide market, especially in EU, North America and Japan.


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Sewon Cellontech Co., Ltd.

ProductsClassification Product Details

Stem Cell System(Cell Therapy)

Chondron™ Autologous Cartilage Cell

RMS Ossron™ Bone Marrow Stem Cell

BabyCell™ Cord Blood Stem Cell

Stem Cell System™ Stem Cell Platform

RegenGraft(BioCollagen Scaffold)

TheraForm™ Skin Scaffold Membrane

SurgiFill™ (RegenSeal™) GTR Scaffold Gel / Membrane

OssFill™ Bone Scaffold Gel

CartiFill™ Cartilage Scaffold Gel

CartiZol™ Joint Scaffold Gel

TheraFill™ Dermal Scaffold Gel

DuoFill™ PRP Scaffold Gel

SERAZENA™ Rejuvenative Bio-Cosmetics

Global Approval Status

Classification ProductRegion

(Regulatory Body)Approval Date

Stem Cell System

Chondron

Korea (MFDS) 2001UK 2009

Netherland 2010Poland 2008India 2011

RMS Ossron

Korea (MFDS) 2009UK 2010

Poland 2008India 2011

BabycellKorea (MW) 2011

EU (CE) 2006 (USCRM Kit only)India (DCGI) 2010

RegenGraft

TheraForm

Korea (MFDS) 2011EU (CE) 2007

USA (FDA 510(k)) 2009Argentina 2011

Turkey 2012

SurgiFillKorea (MFDS) 2012

EU (CE) 2009

OssFillKorea (MFDS) 2012

EU (CE) 2011

CartiFill

Korea (MFDS) 2013EU (CE) 2009Turkey 2012

Argentina 2013

CartiZolKorea (MFDS) 2013

EU (CE) 2015

TheraFill

Korea (MFDS) 2010EU (CE) 2006Israel 2010

Singapore 2012Argentina 2012

DuoFill EU (CE) in process


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SK Chemicals Co. Ltd.

CEOMahnhoon Park

Location310, Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 13494 Republic of Korea

Homepagewww.skchemicals.com/en/

ContactJin Seon ParkPhone: +82-2-2008-2888Fax: +82-2-2008-2959Email: [email protected]

Since entering the vaccine industry in 2002, SK Chemicals has strongly focused on its vaccine R&D capability, obtaining fundamental proprietary technologies for developing vaccines highly demanded around the world.

In line with its R&D efforts, SK Chemicals constructed a new GMP-com-pliant vaccine manufacturing facility in 2011 with cutting-edge single-use, modular production system, which allows highly efficient commercial scale production of different types of vaccines including the company’s own vaccine.SK Chemicals’ new “SKYCellflu” influenza vaccine is being manufac-tured using cell-based production technology, which does not contains antibiotics or preservatives.SK Chemicals has also entered collaboration with the IVI, the Gates Foundation and Sanofi Pasteur for development of vaccines. In Latin America, SK Chemicals is looking to pursue partnerships with variety of collaboration model in consideration, ranging from transfer of technolo-gy to distribution agreements.


SKYCellflucell-culture based influenza vaccine in Korea and third worldwide.

Uses SK’s proprietary technology

R&D PipelinePipeline Description DS PC PI PⅡ PⅢ NDA MKT

NBP606Pneumococcal

Conjugate vaccine○

SKYCellflu Quadrivalent

Quadrivalent Cell-based flu vaccine

○

NBP608

Varicella vaccine ○

Herpes Zoster (Shingles) vaccine

○

NBPTyphoid Conjugate

vaccine○

NBP Vaccine in development ○ ○


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Tego Science, Inc.

CEODr. Saewha Jeon

LocationDaerung Technotown III, 1fl.,115 Gasan digital 2-ro, Gumcheon-gu, Seoul, Korea

Homepagehttp://www.tegoscience.com

ContactDennis W. An, DirectorPhone: 82-2-818-2900E-mail: [email protected]

Skin Cell Therapy… Tego Science will take the initiative!

Tego Science is a biopharmaceutical manufacturer specializing in skin cell therapy for wound healing. It has enjoyed the best reputation with the leading edge of cell culture technology since 2001.Its wound healing skin cell therapy products originating from human epithelial cells are now a mainstay in burn and ulcer clinics with an unmatched track record of safety and efficacy.

ProductsWound HealingKaloderm® – Kaloderm® is a Cultured Epidermal Allograft for deep 2nd degree burn and diabetic foot ulcer. Kaloderm is the only cell therapy product in the world that is indicated to use for a variety of wounds, both acute and chronic.Holoderm® – Holoderm® is a Cultured Epidermal Autograft for deep 2nd and 3rd degree burns with dermal loss. No immunological rejection: 90% take rate in Phase III clinical trial.

Human Skin ModelNeoderm® – 3D human skin model for testing the safety and efficacy of drugs and cosmetics substituting for inhumane and expensive animal testing.

FacilitiesTheir KGMP-certified production facility is operated up to 75% of its full capacity in accordance with the KFDA guidelines. Their new produc-tion facility, also located in Seoul, is under construction and expected to be completed at the end of 2016. The new facility is designed to conform to the global GMP standards and to have the capacity 5 times bigger than the current one.

R&D Pipeline


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company introduction

ViroMed. Co., Ltd.

CEOMr. Yong Soo Kim

Location5th Fl. Bldg. 203 Seoul National University Gwanak-ro, Gwanak-gu, Seoul, 151-747Republic of Korea

Homepagehttp://viromed.co.kr/kor/index_intro.html

ViroMed Co., Ltd. (ViroMed) is a leading biopharmaceutical company and a leader in DNA based gene therapy with a focus on the development of innovative drugs.

ViroMed was established in 1996 and is headquartered in Seoul, Korea with a US presence in Atlanta. ViroMed has assembled a diverse, but technologically and conceptually linked, pipeline of innovative thera-peutics in the areas of cardiovascular and neurological diseases, can-cers, and immune disorders, with 7 projects in clinical stages in the US, Korea, and China. ViroMed has successfully completed two separate phase II clinical studies for diabetic peripheral neuropathy and critical limb ischemia (an extreme form of peripheral artery disease: PAD) in the US and Korea and received approval from the US FDA to initiate phase III study. A phase I/II clinical study for amyotrophic lateral sclero-sis in the US has also been completed. In China, a phase III clinical trial is underway for chemotherapy-induced thrombocytopenia. ViroMed is also running a botanical therapeutics and functional food programs with one prescription drug for osteoarthritis and three functional food products already in Korean market.


PG102Botanical functional food product made from the extract of hardy kiwi and approved by KFDA for functional claim. May help improve immune

hypersensitivity.

HX106Botanical functional food product made from the extract of 4 different herbs

and approved by KFDA for functional claim. May help improve working memory.

HX811Botanical functional food product made from the extract of 10 different

herbs that may improve joint health.

R&D Pipeline

Pipeline Description DS PC PI PII PIII NDA MKTLicensedTerritory

VM202-DPN (US)

DNA based gene therapy target-ing diabetic peripheral neuropa-

thy○ Korea

VM202-PAD (US, China)

DNA based gene therapy targeting chronic non-

healing ischemic foot ulcer in diabetes patients

○Korea, China

VM202-ALS (US)

DNA based gene therapy targeting amyotrophic lateral

sclerosis○ Korea

VM202-CAD (Korea)

DNA based gene therapy targeting coronary artery

disease○ Korea

VM206 (Korea)Therapeutic cancer vaccine targeting Her2 expressing

breast cancer○ Korea

VM501 (China)Recombinant IL-11 protein

targeting chemotherapy induced thrombocytopenia

○ China

korea biopharmaceutical industry

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