Korean Pharmaceutical Industry : development and opportunities

1. Korean Pharmaceutical Industry: development and opportunities Korea Drug Research Association http://www.kdra.or.kr

2. Contents Korea Drug Research Association (KDRA) I ▮ Korea Drug Research Association(KDRA) ▮ KDRA Member Companies ▮ KDRA Organization ▮ Major Activities ▮ Collaboration Opportunities Korean pharmaceutical Industry & Its R&D II ▮ Market ▮ Pharmaceutical Companies ▮ R&D of Korean Pharmaceutical Industry ▮ Key Factors in Korean Success ▮ Korean Approaches for Finding New Drugs ▮ Korean Opportunities

3. Korea Drug Research Association I. Korea Drug Research Association (KDRA) as Korean pharmaceutical innovators’ group Represents R&D-based pharmaceutical & life science companies leading the industry in Korea Established by the law in 1986 as non-profit organization

4. Korea Drug Research Association I. Korea Drug Research Association (KDRA) 57 Member companies having ▮ Korean nationality ▮ industrial leadership in market share & new drug R&D ▮ R&D abilities & experiences with advanced R&D infrastructure (talented manpower, R&D facilities etc.) ▮ advanced manufacturing facilities & sales orgs. Has the same industrial identity as U.S. PhRMA

5. 한국신약개발연구조합 Korea Drug Research Association I. KDRA Member Companies 대한민국 신약개발 중심 기관 Korea Drug Research Association (KDRA)

6. Korea Drug Research Association I. KDRA Organization Board of Directors (20 Companies) ▮Chairman : Ei-hwan, Cho, Ph.D., Chairman of Samjin Pharm. ▮President : Kang-Choo, Lee, Ph.D., Ex-President of KNIH Head Quarter (Planning & Management, R&D Promotion etc.) PharmaTech Business Center(PTBC) National R&D Consortiums (small & bio molecules)

7. Korea Drug Research Association I. KDRA Organization Committee of New Drug R&D Policy Committee of Managing Directors of R&D Centers Committee of Industry-Public Research Collaboration Committee of Regulatory Affairs Professionals Committee of API Development Professionals Committee of Pharmaceutical Research Analysis Committee of KNDA Evaluation

8. Korea Drug Research Association I. Major Activities Representing R&D based pharmaceutical& biotech Industries in Korea Providing unified voice fostering an environmentwhich responds to the needs of Korean R&D based pharmaceutical & biotech Industry Promotion of pharmaceutical & biotech R&D Activities

9. Korea Drug Research Association I. Major Activities Leading & participating in R&D policy-makingin pharmaceutical & biotech fields Planning mid and long-term national R&D programs supported by the government Operation of national new drug R&D consortiums and various kinds of industrial committees

10. Korea Drug Research Association I. Major Activities Support & management of R&D fundssecured from the government etc. Supporting services of R&D collaboration& technology diffusion ▮Establishment & Management of PTBC(PharmaTech Business Center)▮Technology Evaluation & Valuation (through PTBC Technology Business Committee)▮Annual organizing & hosting of "InterBiz Bio-Partnering & Investment Forum"

11. Korea Drug Research Association I. Major Activities State-of-the-art information services& publication of various kinds of industrial reports R&D education and trainning Management of R&D exhibition hall, award(KNDA; Korea New Drug Award) etc.

12. R&D Policy Professional Education & Training Advising &memorializingthe government Industrial Publicity R&D Incubation& Project Support KDRA Activities Export Community Operation of Pharmatech Business Center R&D Information Operation of Awards Investigation & Research Industrial Needsfrom R&Doriented KDRAMember companies Korea Drug Research Association I. Extension ofOpportunitiesfor Joiningthe Government-SponsoredR&D Programs Cost-effectiveR&D Management Securing ofR&D Fund National policygiving priorityto R&D OrientedCompanies Securing ofR&D Fund Renovation ofIndustrial System Professional Group & Societies forexpertise exchange Information ProfessionalEducation Technology ImportTechnology Export R&D Publicity R&DCollaboration Securing ofIdentification As R&D OrientedPharmaceuticalCompasnies Findinga largermarketabroad

13. II. Korean Pharmaceutical Industry & Its R&D Market Market Size : 14.0 bil US$ (2007) Market Growth Rate : Ave 10.1% PER Year (2001-2007)

14. II. Korean Pharmaceutical Industry & Its R&D Pharmaceutical Companies Production GMP Certified KGMP BGMP Finished Products Bulk Pharmaceuticals Quasi-Drugs 229 116 237 351 212

15. II. Korean Pharmaceutical Industry & Its R&D R&D of Korean Pharmaceutical Industry < Current Status of New Drug Approval of Leading Korean Firms as of 2007>

16. II. Korean Pharmaceutical Industry & Its R&D R&D of Korean Pharmaceutical Industry < Current Status of New Drug R&D Projects of Leading Korean Firms >

17. < > Current Status of US FDA IND approvals for New Drug Candidates of Korean Firms II. Korean Pharmaceutical Industry & Its R&D R&D of Korean Pharmaceutical Industry

18. II. Korean Pharmaceutical Industry & Its R&D R&D of Korean Pharmaceutical Industry < R&D of new drugs by therapeutic categories >

19. II. Korean Pharmaceutical Industry & Its R&D R&D of Korean Pharmaceutical Industry < R&D of new drug by active ingredients > Classification of Active ingredient No. of Projects (Active ingredients) % Rank New Chemical Entities 89 79.5 1 New Biological Entities 12 10.7 2 Natural Products 11 9.8 3 Total 112 100

20. II. Korean Pharmaceutical Industry & Its R&D Key Factors in Korean Success Resolute R&D investment by pharmaceutical industry sector   ⇒ Major R&D intensive companies invest 93% to net profit Continuous pursuit of R&D productivity& efficiency to overcome the disadvantageousR&D resources in comparison with the advanced nations Highly Educated & Experienced R&D Manpower

21. II. Korean Pharmaceutical Industry & Its R&D Key Factors in Korean Success Strong Passion for New Drug Developmentin spite of insufficient R&D environment Strategic & Dynamic Nationwide Collaboration Network between the industry, academia and public research orgs. Strong Government Support & R&D Programs since 1982 Strong will & vision for Global Market

22. II. Korean Pharmaceutical Industry & Its R&D Korean Approaches for Finding New Drugs Strategies & Targets Coping with Subdivision of Value Chain Slowdown in R&D Productivity & Profitability Satisfying   the market needs for the innovations in various kinds of fields   the variation of Market Needs for the advanced products & technologies Overcoming the insufficient internal R&D environment & experiences the short R&D history in comparision with advanced countries

23. II. Korean Pharmaceutical Industry & Its R&D Internal Discovery Efforts 15 Korean New Drugs(1999-2008) launched in Korean Market 1 FDA-Approved New Drug(2003) already launched in U.S. etc. 40 Technologies/Drug Candidates licensed-out to Big Pharma etc. (1986-2008) Over 100 New Drug Leads/Candidates under development Over 190 New Tech & IP-Adopted Drugs/Biotech Medicine launched or under development

24. II. Korean Pharmaceutical Industry & Its R&D Licensing Strategies & Efforts License-out Finished : over 40 Technologies/Drug Candidates In progress : Nearly 50 Technologies/Drug Candidates Strategies ▮Early Inroads of foreign market ▮Strategic R&D Collaboration with Advanced Companies ▮Efficient use of experiences in market & regulatory affairs of foreign countries ▮Strategic attraction of investment from licensee

25. II. Korean Pharmaceutical Industry & Its R&D Licensing Strategies & Efforts License-in Core Part in R&D Out-Sourcing Strategies Reinforcement of R&D Abilities Expansion of R&D Portfolio   ⇒ Early Security of Promising New Drug Candidates & Leads Value-up of Promising Technologies   ⇒ Strategic Technology Incubation & Commercialization Value-up of Own Technologies & Drug Candidates   ⇒ Strategic Fusion with external technologies resulting in high value Filling up of Increasing Market Needs   ⇒ Supplementary in Unspecialized R&D Areas

26. II. Korean Pharmaceutical Industry & Its R&D Strategic Alliances Partners Past : Domestic   Public Research Institutions and Colleges & Universities Present : Domestic > Foreign Public Research Institutions, Colleges & Universities, Bio-Startups, Companies Future : Domestic < Foreign   Public Research Institutions, Colleges & Universities, Bio-Startups and Big Pharmas

27. II. Korean Pharmaceutical Industry & Its R&D Korean Opportunities Talented Human Resources World 11th Largest Economy Advanced IT Environment Korean Opportunities Strategic Regional Location Creativity & Innovation Systematic R&D Strategies in Biotechnology Harmonized R&D Collaboration Environment Strong Industrial Needs for Out-Sourcing & Partnership

28. II. Korean Pharmaceutical Industry & Its R&D Collaboration Opportunities Korea USA E.U. Establishmentof Collaboration Network Japan R&DCo-WorksandInvestment Technology Licensing& Transfer Technology cooperation China Canada Australia Etc.

29. Contact Contact Hun Che Cho, Director Research & Development Promotion Dept., Korea Drug Research Association(KDRA) Senior Technology Business Consultant, PharmaTech Business Center(PTBC) 4Fr. Hwa-San Bldg. 474-15, Bangbae-Dong, Seocho-Gu, Seoul. 137-060, Korea T. 82-2-525-3108 F. 82-2-525-3109 E-mail. hccho@kdra.or.kr URL. http://www.kdra.or.kr

30. Korean Pharmaceutical Industry We are all angels with only one wing. We can only fly while embracing each other. - Luciano D. Crecenzo

31. Korean Pharmaceutical Industry Thank you!