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Produced by: Korean Biologics Pipelines 2015 Series eBook of 4th Biologics World Korea 2015

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  • Produced by:

    Korean Biologics Pipelines 2015

    Series eBook of 4th Biologics World Korea 2015

  • As 4th Biologics World Korea 2015 is drawing near, we are glad to compile the

    key information of 17 leading Korean Biologics manufacturers and highlight their

    pipelines for your interest and discussion.

    PREFACE

    CONTENT

    The ranking is in no particular order and listed alphabetically

    The content of this e-Book only represents the opinions of IMAPAC

    All information is provided by our partners or retrieved from our

    partner and Internet

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    Binex Co., Ltd.

    Bioneer Corporation

    Boryung Pharmaceuticals Co., Ltd.

    Celltrion, Inc.

    Chong Kun Dang Pharmaceutical

    Corporation

    CJ Healthcare Corporation

    Daewoong Pharmaceutical Co., Ltd.

    Green Cross Corporation

    HanAll BioPharma Co., Ltd.

    Handok Inc.

    Hanmi Pharmaceutical Co., Ltd.

    Il-Yang Pharmaceutical Co., Ltd.

    ISU Abxis Co., Ltd.

    JW Pharmaceutical Co., Ltd.

    LG Life Sciences, Ltd.

    SK Biopharmaceauticals

    SK Chemicals Co., Ltd.

    ViroMed Co, Ltd.

    Yuhan Corporation

  • 3Since 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.

    BINEX is the CDMO (contract development and manufac-turing organization) in Korea that solves manufacturing bottleneck in biologics industry with proven track records of carrying out GMP manufacturing & process development roles for global market. As the manufacturing hub, BINEX was able to accumulate manufacturing experience and know-how for various types of biologics at the highest GMP standards because BINEX has managed most biologicsdeveloped in Korea.

    Through its manufacturing expertise, BINEX has beenspotted for dealing with multinational pharmaceuticalcompanies by providing top-quality biologics CDMOservice and we are looking forward to expanding ourglobal business capability continuously.

    Remicade is one of the top selling biologics with $8.5 billlion in sales in 2011. This monoclonal antibody drug has a broad indication including Rheumatoid Arthritis and othe inflam-matory conditions. Currently, the clinical phase 1 study of Remicade Biosimilar with RA patients has been completed in Korea and Japan, and phase III study with RA patients has been started in Japan

    CEO:Address:

    Website:Phone:

    E-mail:

    Myoung-Ho Jeong368-3, Dadae-ro, Saha-gu,Busan, 604-846 Koreawww.bi-nex.comSeo Yeon [email protected]

    Binex Co., Ltd.

    Bio Base Camp for Biopharmaceutical Industry Binex Co., Ltd.

    Product NameHuman Growth

    Hormone

    Hylene

    Otra

    Allernol

    Growth Hormone Deficiency

    Treatment ofKeratoconjunctivitis

    (Ophthalmic Solution)

    Treatment of bacterial infections (Ophthalmic

    Solution)

    Treatment of allergic conjunctivitis

    (Ophthalmic Solution)

    Currently Marketed

    Currently Marketed

    Currently Marketed

    Currently Marketed

    Indication Status

    Products

    Product NameRemicade Biosimilar Rheumatoid Arthritis, etc.

    Phase III (Completed)

    Indication Status

    R&D Pipeline

  • 4Bioneer Corporation is Koreas leading biotech company. Bioneer was the first Korean biotechnology company when itwas established in 1992. The company has developed state of art molecular biology products and technologies includingoligonucleotides/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 & instruments. By capitalizing on thefoundational technologies and products developed over 10 years, Bioneer has developed a solidvertically integrated infrastructure to support new higher value-added businesses such as novel RNAi drugdevelopment and molecular diagnostics.

    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 vivodelivery and finally converted to siRNA in the target cells. SAMiRNA is a SCE (single Chemical Entity), which ismanufactured 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 RNAiprodrug system developed to date. Vertically integrated processes within Bioneers 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. Bioneers research and technical support teams which have more than 10 year experience ensure top-quality products and developments to meet unmet therapeutic needs.

    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 develop-ment resources as well as through partnerships with major global pharmaceutical companies.

    CEO:Address:

    Website:Phone:

    E-mail:

    Han-Oh Park, Ph.D.49-3, Munpyeong-dong, Daedeok-gu, Daejeon306-220, Koreawww.bioneer.comJei-Wook Chae, Ph.D.,Head of R&D [email protected]

    Bioneer Corporation

    Leadership in RNAi Therapeutics:

    Bioneers siRNA Drug Development Program using SAMiRNA Technology

    R&D PipelinePreclinicalDevelopmentDiscoveryPrograms Clinical Trials

    Phase I Phase II Phase III

    Solid Cancers(SAMiRNA Survivin)

    Liver CancerSANDFI

    COPDLiver FibrosisAntivirals

    Bioneer Programs

    Partner Program

  • 5Boryung 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 co-prosperity based on human centered values.

    Boryung has conducted R&D activities to develop drug substances from a short-term perspective and developing 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 drug, antineoplastic drug and antibiotic/antiviral etc.

    CEO:Address:

    Website:Phone:

    E-mail:

    Tae Hong, ChoiHead Office 136,Changgyeonggung-ro,Chongro-ku, Seoulwww.boryung.co.krJi Hyun [email protected]

    BoryungPharmaceuticals Co., Ltd.

    Boryung Pharmaceutical Co., Ltd.

    ProductsKanarb (Fimasartan) Kanarb Combination

    R&D Pipeline

    Boryung Pharmaceutical has developed Kanarb, ananti-hypertensive drug that has been approved by the KFDA as the 15th new drug. This is the new ARB devel-oped by Boryung and it was launched in Korea in 2011. By the end of 2013, this product is number one prescribed ARB with performance of USD 30 million in Korea. 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.

    Until now, Boryung has successfully licensed-out Kanarb with Mexico and 12 other Latin countries, Brazil, Russia, and China and we are expecting first oversea launch in Mexico June of this year. Also we are under business licensing dis-cussions with Japan, USA, Europe, Australia etc.

    Boryung is developing Kanarb combination drugsfor more severe patients who are suffering fromhypertension, hyperlipidemia, heart failure anddiabetic mellitus.

    For Kanarb & HTCZ combination drug, named of BKC001 was launched in 2013 and we have also developed Kanarb and CCB combo, named of BKC0002. For CCB combination,

    Phase III clinical trial is now on progress. In additionto these, we are also developing other KanarbCombination drugs as future innovative drug!

    Category

    NCE

    IMD

    Product RS PC PI PII PIII LaunchRGTheraputic Area

    CV

    AN

    CNS

    BKC 001

    BKC 003BKC 002

    BKC 004BSN 001

    BCN 002

    BNT 002

    BVN 001

    BVN 002

    BVN 003

    Biologics

    OO

    O

    OO

    O

    OO

    O

    O

  • 6Celltrions goal is to provide affordablealternatives 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 antibodybiosimilar.

    We are using our accumulated R&Dtechnology and manufacturing capabilities to develop, manufacture & 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 ofadvanced biomedicines.

    Remsima (infliximab) is the worlds first biosimilar mAb to receive positive opinion from an advanced and developed nations regulatory body, which is a monoclonal antibody against tumor necrosis factor alpha (TNF-) used to treat autoimmune diseases like ankylosing spondylitis, rheumatoid arthritis, Crohns Disease,ulcerative colitis, psoriasis and psoriatic arthritis. The European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) had given positive opinion for Celltrion-developed Remsima for sale in the European Union (EU) in June 2013. With this positive CHMP opinion, Celltrion is permitted 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 administra-tive 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 previously had limited access to advanced therapeutics, in particular, those hindered 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-antagonist market and is likely to be the only biosimilar product in the market for the next 4 to 5 years.

    CEO:Address:

    Website:Phone:Fax:E-mail:

    JungJin SeoHead Office 13-6, Songdo-dong,Yeonsu-gu, Incheon,406-840, South Koreawww.celltrion.com+82-32-850-5008+82-32-850-5057contact@celltrion.com (business)[email protected] (investment)

    Celltrion, Inc.

    Celltrions Goal

    Products

  • 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 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-Hodgkins 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 seasonalinfluenza viruses. Celltrion received IND approval from Englands Medicines and Healthcare products RegulatoryAgency (MHRA) to initiate a phase 1 clinical trial for CT-P27, an influenza antibody shown to have efficacy for pandemic and seasonal flu strains, including various subtypes of influenza viruses.

    The results of animal tests conducted by the US Center for Disease Control and Prevention showed that this newantibody 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 worlds first comprehensive influenza virus treatment antibody, ifsucceeded.

    Additionally, Celltrion is developing innovative drug to cure rabies by collaborrating with the US Center for Disease Con-trol 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. Celltrions broad innovative drug pipeline is expected to serve as the driving force behind Celltrions future growth.

    R&D Pipeline

    7

  • CKD has focused on the research and development of New chemical entities(NCE), Incrementally modified drugs(IMDs) and Bio-pharmaceuticals. In the fields of NCE, Camtobellwas launched in 2004, as the first CKD new drug developed by its own technology. Based upon this successful experience, DuvieTM which is a thiazolidinedion derivative for type 2 diabetes has been approved by Ministry of Food and Drug Safety(MFDS) in 2013 and launched on February 2014.

    Phase I clinical trials for CKD-516 (Tubulin inhibitor & VDA) and CKD-581 (Pan-HDAC inhibitor for cancer) are in prog-ress. In addition, CKD-732 (Fumagillin derivative) developed by CKD has been licensed to Zafgen and phase IIa clinical trials have been completed for severe obesity in Australia last year. Recently, CKD-732 confirmed positive results from clinical trials in patients with Prader-Willi syndrome. CKD-519 is a CETP inhibitor which increases HDL cholesterol being developed to treat dyslipidemia. It completed preclinical study and has been approved for Phase I clinical trials. In case of IMDs, CKD is focusing on the development of combination products and DDS for a new type of oral antibiotics and nanoparticles with the skilled infrastructure.

    As Bio-pharmaceuticals, CKD-11101, anti-anemia agent is a biosimilar of NESP in Phase I clinical trialsand CKD-12201, Prophylactic vaccine forthe cervical cancer cause of human papilloma virus infection,has successfully completed Phase I clinical trials. 8

    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 ofpharmaceutical industry in Korea for over 70 years since its inceptionin May 1941.

    CEO:

    Address:

    Website:Phone:

    E-mail:

    Jung Woo Kim,Kyu Don KimLocation 8, Chungjeong-ro,Seodaemun-gu, Seoul, Koreawww.ckdpharm.comIndi Baik,Director Global Business Unit [email protected]

    Chong Kun DangPharmaceutical Corp.

    Chong Kun Dang Pharmaceutical Corp.

    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 indus-try. 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 contin-uous 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, CKDs 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 Koreas 10 New Technologies.

    Products

    R&D Pipeline

  • 9CJ HealthCare started its business as Pharmaceuticals Business Unit at CJ CheilJedang Corporation from 1984. In line with CJs corporate vision, CJ HealthCare has been striving for making people healthier, happier and better convenient with innovative and differentiated pharmaceutical products. As of 1st April, 2014, CJ HealthCare was spun off from CJ CheilJedang Corporation and became a separate pharmaceutical corporate entity with purpose of enhancement of expertise in pharmaceutical business to grow globally.

    CJ HealthCare first developed EPO[Epokine], ciprofloxacin injection[Citopcin] and simvastatin [Simvastar] pharma-ceutical products in Korea. Now, 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 markets as well as highly-regulated but attractive Japan and EU markets. Through our newly established cGMP compliant plant in Osong, CJ Health-Care can secure global standard manufacturing facilities and operation capabilities.CJ HealthCare will make its best efforts to jump into a leading position among global pharmaceutical companies.

    CEO:Address:

    Website:Phone:

    E-mail:

    Dal won Kwak, Chul ha KimHead Office CJ CheilJedang Center, 330, Dongho-ro, Jung-gu,Seoul 100-400, Koreawww.cjp.co.krKwang Hee Hong, PhD, MBAHead Global Business [email protected]

    CJ HealthCare Corporation

    CJ Healthcare Corporation

    1. Epokine (rh-EPO)- Epokinewas developed 1st in Korea and 3rd in the world. Epokineis safe and effective in treating anemia of hemodialysis patients with end-stage renal disease.

    2. Leukokine (rh- G-CSF) - Chemotherapy in advanced cancer patients and in acute Leukemia patients can cause the Neutropenia. Leukokinecan help to support their natural defenses during strong chemotherapy.

    3. Vancorin (Vancomycin) - Vancorinis the best choice for MRSA & MRSE.

    4. Tapocin (Teicoplanin)- Tapocinhas excellent antibacterial effects on MRSA, MRSE and Enterococcus.

    5. CONDITION (Hangover relief drink) - CONDITIONhas launched in 1992 creating a new market of hangover relief drink in Korea.

    6. HongSamJin Gold (Red Ginseng drink) - HongSamJin Gold is anoutstanding energy drink produced with 6-yeared red ginseng.

    7. HutGaeSoo (Thirst quenching tea drink) - HutGaeSoocontains the goodness of Hovenia dulcis with its function of liver protection.

    Products

  • 1. China -Vancomycin Inj., Teicoplanin Inj., CONDITION

    2. Japan -Cefozopran, Cefotiam, Cefmenoxime, Ceftriaxone Inj., Ceftazidime Inj.

    3. Southeast Asia- EPO, G-CSF, Vancomycin Inj., Teicoplanin Inj., Ciprofloxacin Inj., Moxifloxacin Inj.,Ceftriaxone Inj., Ceftazidime Inj.

    4. Africa - EPO, G-CSF

    5. The Middle East - EPO, G-CSF, Vancomycin Inj., Levofloxacin Inj., Ciprofloxacin Inj., Ceftriaxone Inj.,Cefotaxime Inj., Ceftazidime Inj.

    6. Latin America - EPO, G-CSF, Vancomycin Inj., Teicoplanin Inj.

    Global Business

    10

    R&D Pipeline

    Product Phase Therapeutic Area

    Vogmet

    CJ-12420

    CJ-12406

    CJ-12524

    2nd Generation EPO

    2nd hGH

    Varicella-zoster virus Vaccine

    CJ-30056

    CJ-30059

    CJ-30060

    CJ-30049

    Launched

    PII

    PI

    Pre-clinical

    PI

    PI

    Pre-clinical

    P3

    P2

    P1

    Approved

    Diabetes

    GERD, Licensed

    H, pylori eradication, Licensed

    Anti-cancer (Targeted treatment)

    Anti-Anemia

    Growth Hormone

    Chicken Pox Vaccine

    Anti-Diabete

    Anti-hypertension

    Anti-hypertension

    Anti-cancer

  • 11

    Daewoong Pharmaceutical is the pharmaceuticalcompany 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

    Lee, Jong WookHead Office 163-3, Samsung-dong,Kangnam-gu, Seoulwww.daewoong.comAlice Lee, ManagerConnect & [email protected]

    CEO:Address:

    Website:Phone:

    E-mail:

    Seong ho Jeon, General ManagerGlobal Strategy [email protected]

    Daewoong Pharmaceutical Co., Ltd.

    DaewoongPharmaceutical Co., Ltd.

    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 branches 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 developing 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, Alzheimers 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.

  • IMD (Incrementally Modified Drugs)

    DescriptionMOACode Development StatusR MPre PI PII PIII

    DWJ01

    DWJ02

    DWJ03

    DWJ04

    DWJ05

    DWJ06

    DWJ07

    O

    O

    O

    O

    OO

    O

    R&D PipelineNew Chemical Entities

    12

    DescriptionMOACode Development StatusR MPre PI PII PIII

    DWP05195DWP09031

    DWJ205DWJ206DWJ208

    TRPV1 AntagonistAggregation Inhibitor

    FungicidalAPA (Reversible)

    Ion Channel Blocker

    Neuropathic PainAlzheimer Program

    Antifungal-Fungicidal ProgramAntiulcer Program

    Cancer Pain, Low-Back Pain

    OO

    OOO

    Biologics

    DescriptionMOACode Development StatusR MPre PI PII PIII

    DWP431

    DWP453

    DWP401

    DWJ1121DWJ1142DWP412

    DWJ172DWP143

    DWP420

    BMP-2

    EGF

    hGHEPO

    Botulinum toxin Type A

    Dental sinus lifting graft

    Spinal fusion device

    Diabetic foot ulcer, spray type

    Acute wound healing (OTC)

    Oral mucositis, spray type

    Lyophilized powder

    Pen type injector + Liquid cartridge

    Biosimilar, Recombinant Human Erythropoietin

    Anti-wrinkles

    O

    O

    O

    O

    OO

    O

    O

    O

    5-HT4 Agonist

    HMG CoA Reductase Inhibitor + Angiotensin2 Blocker

    Acetylcholine EsteraseInhibitor

    PDE-5 Inhibitor

    PPI + Antibacterial

    NK1 Blocker

    HMG CoA Reductase Inhibitor + PPARa Agonist

    GI Motility Enhancer, Sustained Release

    Hyperlipidemia/Hypertension,Combination Drug

    Alzheimers Disease, Patch

    Erectile Dysfunction, Chewable Tablet

    H.pylori, 3 Fixed Dose Combination

    Antiemetic, Nano Delivery

    Hyperlipidemia, 2 Fixed DoseCombination

  • Il-Sup, HuhLocation 107, Ihyeon-ro, 30 beon-gil, Giheung-gu, Yongin, 446-770, Koreawww.greencross.comH.G. Beak, Team [email protected]

    13

    Green Cross Corporation (GCC) is an exemplary R&D-oriented pharmaceutical company that leads the bio-technolo-gy industry in Korea. This becomes clear acknowledging what GCC has achieved since its foundation in 1967.

    GCC has pioneered in the field of biopharmaceuticals, such as vaccines, plasma derivatives, recombinant proteins, diagnostics and therapeutic antibodies. GCC has been well known for the R&D achievements over the years with commercialization of HepavaxTM B, the worlds best-selling Hepatitis B vaccine, HantavaxTM, the worlds first epidemic hemorrhagic fever vaccine, and Varicella Vaccine-GCC inj., the worlds second chicken pox vaccine.

    A complete flu vaccine pipeline includes Seasonal Influenza vaccine (GC FluTM), H1N1 vaccine, Avian Influenza vaccine and so on. GCC is also pursuing opportunities in rare diseases developing therapies for Hunter Syndrome (HunteraseTM), and Fabry disease. With continuous investment in R&D, its portfolio now includes gene/celltherapeutics and small molecule drugs. In 2013, GCC earned U$815 million in revenues recording it as the 2ndlargest Korean pharmaceutical company and invested U$74.4 million in R&D which is one of the largest in Korea.

    Starting from the nations first Albumin production in 1971, GCC currently manufactures more than 12 plasma deriva-tives including Immunoglobulin, Anti-hemophilic factors, and Anti-thrombin factor. Recent developments includeB-domain deleted recombinant Factor VIII (BDD rFVIII), GreenGene FTM, a 3rd Generation of recombinant Factor VIII for Hemophilia A treatment.

    GCC succeeded to develop the worlds third Hepatitis B vaccine in 1983, the worlds first epidemic hemorrhagic fever vaccine in 1988, and Varicella Vaccine-GCC inj., the worlds second chicken pox vaccine. With the construction of our Hwasun plant, a vaccine-dedicated manufacturing plant, the seasonal influenza vaccine GC FluTM became the fourth product in the world to obtain the Pre-Qual-ification (PQ) approval from the WHO.

    Green Cross Corporation

    Products

    CEO:Address:

    Website:Phone:

    Fax:E-mail:

    Green Cross Corporation

    Hong-kwon Woo, Team [email protected]

    Plasma Derivatives & Recombinants

    Vaccines

  • R&D Pipeline

    14

    GCC has provided a broad range of ethical medicines for cardiovascular, cerebrovascular, hypertensive, & metabolic diseases. Along with our cataplasma products (one of our core OTC products), GCC also has provided OTC products in fields of respiratory, dermatology & immunology.

    ETC & OTC Medicines

    Indication R MANC IND PhI PhII PhIII NDASeasonal flu

    Seasonal flu (Cell culture)

    Quadrivalent Influenza Vaccinefor Sesonal flu

    Anthrax

    Tetanus, diphteria

    Tetanus, diphteria and pertussis

    Hemophilia A

    Hunter Syndrome

    Infections

    Infections

    Neutropenia

    Fabry Disease

    Anti0thrombotics

    Cancer

    ProjectGCFLU

    GC3106A

    GC3110A

    GC1119GC2107MG4101

    GCPCG

    GC1107GC111A

    GreenGene F

    Hunterase

    IVIG-SN 5%

    IVIG-SN 10%

    GC1109

    US

    US

    US

    US

  • 15

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

    CEO:Address:

    Website:Phone:

    E-mail:

    Dr. Sungwuk KimLocation 11-10,Sincheon-dong, Songpa-gu, Seoulwww.hanallbiopharma.comSoonim Lee, [email protected]

    U.S. BranchHPI. Inc.9605 Medical CenterDrive, Suite #290Rockville, MD, 20850S.T. Oh, [email protected]

    HanAll BioPharma Co. Ltd.

    R&D Pipeline

    HL156CAN

    HL036

    HL161

    HL009

    HL040

    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 defeated AMPK signalingfunction 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.*Preclinical Stage (Aug.2013)HL036 is TNF-alpha receptor fragment for the treatment of local inflammatory diseases caused by TNF-alpha 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, HanAlls TNF receptor fragment will have greater volume of distribution when administered topically compared to current-ly 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 eficacy. It is anticipated that higher concentrations of HL036 will be found in targeted ocular areas when administered topically, preventingsystemic ADEs. HanAll aims to utilize unique property of HL036 for the indication of dry eyes bydeveloping ophtalmic solution.*Preclinical Stage (Aug.2013)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 presents 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.*Preclinical Stage (Aug.2013)

    InformationProduct

    HL009, adenosylcobalamin liposomal gel, has three different potential mechanisms of actions for the treat-ment 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. Adenosyl-cobalamin 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.*KR Phase II (complete) / US Phase II (complete) (Aug 2013)

    HL040, a fixed dose combination product, is composed of atorvastatin and losartan for the treatment of lyperlipidemia and hypertension. HanAll finished the phase I study, and currently conducting phase III trial in Korea and phase I study in US.*KR Phase III (in-progress) / US Phase I (complete) (Aug 2013)

  • 16

    HANDOK (Chairman & CEO Young-Jin Kim), a leading innovation-driven pharmaceutical/health-care company in Ko-rea, develops, manufactures and distributes healthcare solutions to improve the health and quality of human life.

    It was founded in 1954 and has been dedicated to developing and providing innovative pharmaceutical products (Pre-scription drugs & OTC drugs), medical devices, and in vitro diagnostics. Handok grew with its joint venture partner Hoechst/Aventis/Sanofi from 1964 to 2012. In several areas Handok has also established strategic collaborations with multiple multinational pharmaceutical companies. Handok ended its joint venture relationship with Sanofi in 2012. In 2013, Handok changed its company name from Handok Pharmaceutical Co., Ltd to Handok Inc. and declared its vision to become, The Health Innovator as Koreas leading global healthcare company.

    CEO:Address:

    Website:Contact Person:

    E-mail:

    Kim YoungJinLocation 132, Teheran Street, Gangnamgu, 135-923, Seoulwww.handok.co.krSoHyun KwonHead of Licensing & Business Development [email protected]

    Handok Inc.

    Handok Inc.

    Main Products

    R&D Pipeline

    is the first fixed dose combination of glimepiride and metformin HCl in Korea.is the combination with Sufonylurea + Metforminrecommended 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 glycemictarget than Metformin.has been registered by 135 countries.

    Amaryl M(Glimepiride + Metformin HCl)

    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 ReleaseMicro-coating Technology).one a day can improve patients compliance.has been registered by 33 countries.

    Amaryl Mex(Glimepiride + Metformin HCl)

    ProjectCode

    LeadSelection

    Candidate Selection

    LeadOptimization Non-clinical Phase I Phase II Phase III

    HL5171

    HL5521

    HL2351

    HL2353

    HL5201

    HL5945HL5501

    Indication

    Cancer

    Glaucoma

    Rheumatoid Arthritis/Orphan

    Growth Hormone Deficiency

    Diabetes/Obesity

    Alopecia

    Hemophilia

    Diabetes

    AMD

    HL2356

    HL1513 (IMD) BE study

  • 17

    CEO:Address:Website:

    Gwan-Sun LeeLocation 14, Wiryeseong-daero, Songpa-gu, Seoul 138-724, Koreawww.hanmipharm.com

    Christine LeeManager of Global

    Business Development+82-2-410-8761

    [email protected]

    LICENSING OUT

    Si-Young JungSenior Manager of

    In-Licensing+82-2-410-9292

    [email protected]

    LICENSING IN

    Sangjae LeeSenior Manager of

    Export Business+82-2-410-9078

    [email protected]

    EXPORTINFORMATION MANAGEMENT

    Kyoung Woo LeeLicensing Information

    Manager+82-2-410-9291

    [email protected]

    Established in 1973, 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 strat-egy from first generics to IMD &FDC (Incrementally Modified Drug and Fixed Dose Combination) to new drug develop-ment 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 de-velopment/marketing collaborations, Hanmi is trying to develop and provide differentiated treatment options to patients suffering from various disease.

    Hanmi Pharmaceutical Co., Ltd.

    R&D PipelineSmall Molecule Pipeline (as of Aug. 2013)

    Category Candidates Characteristics Development Stage

    Oncology

    Oraxol

    Oratecan

    HM781-36BKX-01

    HM61713

    Paclitaxel + HM30181A

    Irinotecan + HM30181A

    Orally active pan-Her inhibitor

    Src kinase and tubulin dual inhibitor

    EG FR mutant selective inhibitor

    Phase II Licensed out to Kines (US)

    Phase I Licensed out to Kines (US)

    Phase II (KR)

    Phase I (KR)

    Phase I (EU)

    LAPSCOVERY (Long-acting Protein/Peptide Discovery Technology) Pipeline (as of Aug. 2013)

    Candidates Characteristics Development StageLAPS-Exendin (HM11260C)

    LAPS-hGH (HM10560A)

    LAPS-GCSF (HM10460A)

    LAPS-EPO (HM10760A)

    LAPS-IFN (HM10660A)

    LAPS-Insulin (HM12460A)

    Long-acting Exendin-4 analog

    Long-acting hGH

    Long-acting G-CSF analog

    Long-acting EPO

    Long-acting IFN

    Long-acting Insulin

    Phase II (US)

    Phase II (EU)

    Phase II (US)

    Phase I (US)

    Phase I (MX)

    Phase I (US)

  • 18

    Fixed-dose Combination Pipeline (as of Aug. 2013)

    Project Name Combination Development StageAmosartan

    HCP0703HCP0912HCP1102HCP0613HCP1103HCP1104HCP0910

    Amlodipine / Losartan

    Pseudoephedrine / Levocetirizine

    Irbesartan / Atorvastatin

    Montelukast / Levocetirizine

    Mosapride / Bacillus subtilis / Streptococcas feacium

    Ambroxol / Levodropropizine

    Aceclofenac / Eperisone

    Fluticason propionate / Salmeterol

    Regulatory stage in ex-Korean territories

    Phase III

    Phase III

    Phase III

    Phase II

    Phase I

    Phase I

    Phase I

  • 19

    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, Il-Yang 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.

    CEO:Address:

    Website:

    Phone:Fax:E-mail:

    Dong Yeon, KimLocation IL-Yang Bldg. 544-5 Dogok-dong, Gangnam-gu, Seoulwww.ilyang.co.krSun Park, Ph.D.General Manager/Licensing [email protected]

    Il-Yang Pharmaceutical Co., Ltd.

    Il-Yang Pharmaceutical Co., Ltd.

    Products

    2nd generation Bcr-Abl tyrosine kinase inhibitor (TKI) for the treatment of Philadelphiachromosome positive (Ph(+)) CML.Indication: Ph(+) chronic myeloid leukemia (CML) in chronic phase (CP) or acceleratedphase (AP).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.Key features - No serious side effect, Early efficacysignals higher than initial MCyR response at 6 month.

    Supect (API: Radotinib)

    14th New Drug developed in KoreaNoltec is a Proton PumpInhibitor that controls the secretion of gastric acid for the treatment of GU, DU, GERD/EE, and NERDGreater effect on Severe GERD patients, lowreoccurrence, no symptoms of night time heartburn, and low DDI.

    Noltec (API: Ilaprazole)

  • R&D Pipeline

    20

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

    Anti-Viral agent IY 5741

    Ilaprazole

    GU / DU

    EE / GERD

    NERD

    CML-CP

    CML-CP

    Virology

    Korea, China

    Korea USA

    IY5741

    Vaccine

    Korea

    Multi national

    Multi nationalRadotinib

    Virology

    Compound Application Country Ph I Ph II Ph III NDA Marketed

    ongoing

    ongoing

  • 21

    1) ISU ABXIS Innovative Model Shift from orphan drug-specialized company to a globalbiotechnology 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 phaseB. Focus on the development of novel anticancer antibody drug and blockbuster biosimilar drugC. Specialized technology - Antibody screening technology - Efficacy verification - Therapeutic antibody production - Clinical Development - GMP facility approved by 7 different countries including Korea

    3) Differential business model A. Global licensing in early development phase B. Full experience in ERT development : Orphan drugsC. Development for the next generation blockbuster biosimilar drugs D. Business focus on the BRIC market

    ISU Abxis Co., Ltd.

    Company Profile ProductsProduct NameClotinab (Antiplatelet antibody, Abciximab)

    Abcertin(Recombinant enzyme protein, Imiglucerase)

    Fabagal(Recombinant enzyme protein, Agalsidase beta)

    a. The worlds second Abciximab 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)

    a. The worlds second Imiglucerase b. Recombinant human glucoserebrosidases for enzyme replacement therapy (ERT) c. Designated as orphan drugd. Indication: ERT for Gauchers disease

    a. The worlds second Agalsidase betab. Recombinant human alpha-galactosidase for enzyme replacement therapy (ERT)c. Designated as orphan drugd. Indication: ERT for Fabrys disease

    Product Profile

    CEO:Address:

    Website:

    Phone:Fax:E-mail:

    Daeseong KimGlobal R&D Center, Bldg. C, 5th Floor,22, Daewangpangyo-ro 712 Beon-gil,Bundag-gu, Seongnam-si, Gyeonggi-do,463-400 Koreawww.abxis.comHyouna Yoo, Senior [email protected]

    R&D PipelineProduct Indication

    Antibody

    Enzyme

    Antibody

    Enzyme

    Enzyme

    Antibody

    Antibody

    Product

    Lead Dev

    Process Dev

    Launched (2007)

    Launched (2012)

    Launched (2014)

    Preclinical

    Process Dev

    StatusMetastatic

    Hemophilia B

    Anti-coagulent

    Gaucher disease

    Fabry disease

    Breast cancer

    Rheumatoid Arthritis

    ISU104

    ISU304

    Clotinab

    Abcertin

    Fabagal

    ISU103

    ISU202

    Novel Drugs

    Orphan Drugs

    Bio-similars

  • 22

    CEO:Address:

    Website:

    Kyung Ha Lee2477, Nambusunhwan-ro, Seocho-gu, Seoul, Koreawww.jw-pharma.co.kr

    BUSINESS DEVELOPMENT (LICENSING)

    Daekyung KohProduct Development

    and Planning+82-2-840-6857

    [email protected]

    EXPORT (APIs/FINISHED PRODUCTS/CMO BUSINESS)

    Ji Yong ParkChief of Intl Sales Team -1

    Global Business Division+82-2-840-6774~6

    [email protected]

    CORPORATERESEARCH PLANNING

    Sung Hwa SonCorporate Research and Development+82-2-840-6935

    [email protected]

    Major Export Products

    JW Group provides pharmaceuticals vital for maintaining the lives of patients such as anticancer drugs and antibiotics, and has developed into a leading pharmaceutical company and global manufacturer of I.V. Solutions.

    For almost 70 years ever since its foundation in 1945, we focus on healthcare, ETC, OTC, diagnostics, medical equipment. Based on new technologies and services for healthy lives of human beings, JW Pharmaceutical has built up strong sales network across the country and superior pipelines in I.V. solutions, antibiotic, cardiovascular, gastrointestinal, nephrology/antianaemic, anticancer, diabetes, gout and neurosychiatry.

    JW Pharmaceutical Co., Ltd.

    Type Product Group

    Finished Product

    API(Active Pharmaceutical Ingredient)

    1. Carbapenem Antibiotics2. Amino Acid Solutions3. General I.V. Solutions & Other Sterile Solutions4. Anticancer Agents5. Antimicrobial & Antifungal Agents6. Gastrointestinal Agents7. Topical8. Multivitamins9. Agents for Antibiotics10. Miscellaneous

    1. Carbapenem Antibiotics: Inipenem/Cilastatin, Meropenem2. Anti-fungals: Ketoconazole, Itraconazole, Fluconazole3. Chiral Products for Custom Synthesis & Specialty Amino Acid4. Miscellaneous

  • 23

    R&D Pipeline

    JW is focusing on developing Biologics as well as Small molecules in the areas of oncology, endocrinology andimmunology by employing itsnovel platforms.

    URGO Hilmogel

    WINUF Injection

    URC102

    THRUPAS ODT

    ZEPEED

    CreaVax RCC

    CreaVax HCC

    CreaVax BC

    CreaVax RA

    Actemra

    Actemra SC

    Dia-M

    Livasartan

    URGO Dressing

    Guardlet

    THRUPAS Tad

    NCE

    NBE

    Fixed-dosecombination

    Other

    Category Product DS PC NDA MKTPIIIPIIPIClinical Trials

    CWP291

    Wound Healing

    Total Parental Nutrition

    Gout

    Prostatism

    Erectile Dysfunction

    Oncology

    Oncology

    Oncology

    RA

    RA

    RA

    Mitiglinide/Metformin

    Pitavastain/Valsartan

    Wound Healing

    Diabets

    Prostatism

    Indication

    Oncology

    Oncology

    Pipeline represents progress of R&D programs since 2010CreaVax RCC was approved as pharmaceuticals for export

    URGO Hilmogel

    WINUF Injection

    URC102

    THRUPAS ODT

    ZEPEED

    CreaVax RCC

    CreaVax HCC

    CreaVax BC

    CreaVax RA

    Actemra

    Actemra SC

    Dia-M

    Livasartan

    URGO Dressing

    Guardlet

    THRUPAS Tad

    NCE

    NBE

    Fixed-dosecombination

    Other

    Category Product DS PC NDA MKTPIIIPIIPIClinical Trials

    CWP291

    Wound Healing

    Total Parental Nutrition

    Gout

    Prostatism

    Erectile Dysfunction

    Oncology

    Oncology

    Oncology

    RA

    RA

    RA

    Mitiglinide/Metformin

    Pitavastain/Valsartan

    Wound Healing

    Diabets

    Prostatism

    Indication

    Oncology

    Oncology

  • 24

    LG Life Sciences is Koreas 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 onlyUS 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.

    CEO:Address:

    Website:Phone:

    E-mail:

    Il-Jae JungLG Gwanghwamun Bldg.92, Sinmunno-2ga, Jongno-gu, Seoul, Koreawww.lgls.comJong-heon Won, ManagerBusiness Development Team [email protected]

    LG Life Sciences, Ltd.

    LG Life Sciences, Ltd.

    Products

    Fast Active, the most potent quinoloneantibiotic in the world, commercialized in over 30 countries worldwide.

    Factive

    The right choice for managing short stature recombinant human growth hormone with proven efficacy and safety since 1993.

    Eutropin

    Human recombinant erythropoietin, safe and effective treatment for anemia of chronicrenal failure.

    Espogen

    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 an ovulation.

    Follitrope

    High molecular weight hyaluronic acid visco supplement made by microbial fermentation for low side-effect, quality proven by EMEA and CE marking.

    Hyruan Plus

    A novel dipeptidyl peptidase IV (DPP IV) inhibitor for T2DM with good efficacy and safety profiles.Approved by the KFDA in June, 2012.

    Zemiglo

  • SR-hGH - The worlds 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.

    R&D Pipeline

    25

    1) Chemicals

    NCE

    IMD*

    Class Product Indication DS PC NDAPIIIPIIPIClinical Trials

    LC280126LC350189LC51SPA

    LC52CIS

    LC54AID3

    LC53LE0H

    ZB Combi

    VR Combi

    ZemiMet

    ZemiSU

    ZemiStatin

    ZemiARB

    Myocardial Infaction

    Hyperuricemia, Gout

    Multiple Sclerosis

    Type 2 Diabetes

    Metabolic Disease

    Multiple Myeloma

    Hypertension

    Hypertension/Hyperlipidemia

    Type 2 Diabetes

    Type 2 Diabetes

    Diabetes / Hyperlipidemia

    Diabetes / Hypertension

    o

    o

    o

    o

    o

    o

    o

    o

    o

    o

    o

    o

    *IMD = Incrementally modified drugs

    2) Biologics

    Biobetter

    Biosimilar

    Vaccine

    HA-basedproduct

    Class Product Indication DS PC NDAPIIIPIIPIClinical Trials

    LB03002LBEC0101

    LBALLBDPLBBZ

    DTwP-HepB-Hib (liquid)

    LBFL0101

    LBVCLBVDLBVE

    LBSA0103

    YVOIRE contour plus

    GHD (global)

    Rheumatoid Arthritis

    Rheumatoid Arthritis

    Anemia

    Colorectal Cancer

    D/T/P/HBV/M

    Influenza

    Poliomyelitis

    D/T/P/HBV/M/IPV

    Pneumonia

    Osteoarthritis

    Soft Tissue Augmentation

    o

    o

    o

    o

    o

    o

    o

    o

    o

    o

    o

  • 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 14 autho-rized 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 devel-opment of its assets in the areas of epilepsy, irritable bowel syndrome, Parkinsons disease, and cognitive impairment associated with schizophrenia.

    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 Biopharma-ceuticals, such as continuous flow synthesis, low temperature reactions, and catalytic conversions that differentiate the company from other chemical suppliers.

    CEO:

    Address:

    Website:Phone:

    E-mail:

    Christopher C. Gallen M.D., Ph.D.99 Seorin-dong, Jongro-gu,Seoul 110-110, Koreawww.skbp.comHaein ShinTeam Leader, Business Development [email protected]

    SK Biopharmaceuticals

    SK Biopharmaceuticals

    R&D Pipeline

    Products Indications Development StageDiazepam Nasal Spray

    Carisbamate (YKP509)

    SKL-N05

    YKP3089

    YKP10811

    SKL-PD

    SKL-A4R

    SKL-PSY

    SKL-ADHD

    Epilepsy Project

    Pain Project

    Schizophrenia Project

    HD Project

    Acute Repetitive Seizures

    Epilepsy, Infantile Spasm

    Narcolepsy, Obstructive Sleep Apnea, Attention Deficit

    Hyperactivity Disorder

    Epilepsy, Neuropathic Pain, Bipolar Disorder

    Chronic Constipation, Irritable Bowel Syndrome

    Parkinsons Disease, Neuroprotection

    Cognitive Impairment Associated with Schizophrenia

    Bipolar Disorder

    Attention Deficit Hyperactivity Disorder

    Epilepsy

    Neuropathic Pain

    Schizophrenia

    Huntingtons Disease

    NDA

    Phase III

    Phase III

    Phase II

    Phase II

    Phase I

    Phase I

    Preclinical

    Preclinical

    Discovery

    Discovery

    Discovery

    Discovery 26

  • Product Information

    NCE 401(RIF, Radio-infuced Fibrosis agent) New Chemical Entity, In preclinical study

    NCE 402(Type 2 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

    NCE 601(anti-Heamophilia agent,4th generation Factor VIII)

    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

    27

    The life science business of SK Chemicals contributes to the enhanced health and life quality of mankind by developing new synthetic and drugs, including SUNPLA - Koreas first new drug, vaccines, innovative production technologies, and combining IT technologies withhealthcare services.

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

    SK Chemicals Co., Ltd.

    CEO:Address:

    Website:Phone:

    E-mail:

    Chang Geun, Kim686, Sampyeong-dong, Bundang-gu, Seongman-si, Gyeonggi-do,463-400 Koreawww.skchemicals.comSojin, JungAssociate Research Scientist [email protected]

    SK Chemicals Co., Ltd.

    R&D Pipeline

  • ViroMed Co., Ltd. (KOSDAQ, 084990) is a leading biotechnology company located in Seoul, Korea founded in 1996 with a US presence doing business as VM BioPharma in Atlanta. The company has two main areas of focus: DNA/protein-based biopharmaceuticals and phytotherapeutics (botanical drugs/nutraceuticals). ViroMed now has six main products in its pipeline targeting cardiovascular disease, cancer, and immune-related disorder, with clinical trials being conducted in the US, Korea, and China.

    CEO:Address:

    Website:Contact Person:

    E-mail:

    Kim YongsooBldg 203, Seoul National University,#599 Gwanak-ro, Gwanak-gu, Seoulwww.viromed21.comYoungtae HongSection Chief,Strategic Business Development [email protected]

    ViroMed Co., Ltd.

    Viromed Co., Ltd.

    Main Products

    Product Target Disease Development Stage

    VM202-PAD

    VM202-DPN

    Critical Limb Ischemia

    Diabetic Peripheral Neuropathy

    Plasmid DNA

    Plasmid DNA

    USA/Korea

    USA

    China

    Korea

    Phase III (completed)

    Phase II (ongoing)

    VM202-ALS Amytrophic Lateral Sclerosis Plasmid DNA USA Phase I/II (ongoing)

    VM202-CAD

    VM206

    VM501Coronary Artery Disease

    Breast Cancer

    Chemotherapy-InducedThrombocytopenia

    Plasmid DNA + Catheter

    Plasmid DNA + Virus

    Recombinant Protein

    Korea

    Korea

    China

    Phase II (planned)

    Phase I (completed)

    Phase III (ongoing)

    Phase II (ongoing)

    Technology Country

    28

  • VM202 is a DNA-based medicine for the treatment of ischemic cardiovascular diseases via therapeutic angiogene-sis. It is designed to express isoforms of hepatocyte growth factor (HGF) for the treatment of coronary artery disease (VM202-CAD) and peripheral artery disease (VM202-PAD) by 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 treat-ing ischemia. VM202 has also been shown to stimulate the growth and regeneration of nerve cells. Therefore, it is also being developed for the treatment of diabetic neuropathy (VM202-DPN), a common complication of type 2 diabetes mellitus that usually manifests itself as a disease affecting the nerves in the leg, causing intense pain and difficulty in movement. VM202 target indication has expanded to include amyotrophic lateral sclerosis (ALS), also known as Lou Gehrigs disease. Lou Gehrigs disease is a rare neurodegenerative disease that has no effective treatment available. For VM202 to enter the global market, the company is carrying out multinational late stage clinical trials in the US, China, and Korea.

    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 clinicaltrials performed in China, significant therapeutic effects were shown without severe adverse effects.

    Phase III clinical trial is currently ongoing in China.

    VM206 is a therapeutic cancer vaccine that has potential applications for breast, ovarian, and pancreatic cancers. Phase I clinical trial has been completed in Korea with its results being prepared to be published in an international scientific journal.

    VM202 DNA Therapeutics Inducing Angiogenesis and Nerve Regeneration

    VM501 Protein Therapeutics for Thrombocytopenia

    VM206 Therapeutic Cancer Vaccine

    29

    Main Products

  • 30

    CEO:Address:

    Website:Phone: Fax:

    Yoon Searb, Kim49-6, Daebang-dong, Dongjak-gu,Seoul, 156-754, Koreawww.yuhan.co.kr+82-2-828-0181+82-2-828-0300

    Yuhan Corporation

    Yuhan Corporation

    R&D Pipeline

    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. Yuhans overseas business activities include:

    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 Yuhans Revanex, the worlds 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.

    New drug development projects with multinational partners. Developing and optimizing cost effective synthetic processes for APIs and intermediates.

    Product Indication Pre-clinical LaunchingP1 P2 P3Gastrointestinal Disorder

    Metabolic Disorder

    Cardiovascular Disorder

    Immunology / Inflammation

    Oncology

    Other

    YH4808 (K+ -competitive acid blocker)

    YH_Bio1

    YH 14617

    YH 16410 (Fixed Dose Combination)

    YH_Chem3 (LXR modulator)

    YH1177 (Fixed Dose Combination)YH1176 (Fixed Dose Combination)

    YHB1411-2 (Anti-TNF antibody)YH14618 (TGF modulator)YH14619 (TGF modulator)

    YH_Chem1 (GPR119 agonist)

    YH 14755 (Fixed Dose Combination)

    YH 14700 (Fixed Dose Combination)

    YH_Chem2

    YH_Herb

    YH_Chem4

    YH_Bio2

    YHD1023

    YH_Chem5

    YHD001YHD14642

    YHD14810

    YH12852 (5-HT4 agonist)GERD / NSAIDs induced GI injury

    Diabetes

    Diabetes

    Hypertension / Hyperlipidemia

    Atherosclerosis

    Otitis mediaOtitis media

    Rheumatoid ArthritisDegenerative disc diseaseOsteoarthritic disease

    Diabetes

    Hyperlipidemia / Diabetes

    Hypertension / Hyperlipidemia

    Diabetes

    Tinnitus

    COPD

    Cancer

    Erectile dysfunction

    Cancer

    AsthmaPeriodontitis

    Cancer

    IBS-C / Chronic constipation

    P2 initiated

    Pre-clinical

    P2 initiated

    Pre-clinical

    Pre-clinical

    Pre-clinical

    Pre-clinical

    P1 on-going

    P1 / 2a on-going

    Pre-clinical

    Pre-clinical

    Pre-clinical

    P3 on-going

    Pre-clinical

    Pre-clinical

    Pre-clinical

    Pre-clinical

    P2

    Pre-clinical

    P2

    P2

    Pre-clinical

    Pre-clinical

  • 9-10 June 2015 | Seoul, South Korea

    The ONLY and MOST Targeted Biologics and Bio-similars Focused Platform in Korea!

    Meet top minds from over 100 key players in Korean biologics industry at:

    For further assistance, please contact:

    Amber Liang

    E: [email protected] | T: +65 6493 1871

    VISIT OUR WEBSITE TODAY:http://www.imapac.com/business_conference/biologics-world-korea-2015/