全球医药产业研究与发展的最新趋势

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1. 全球医药产业研究与发展的最新趋势胡江滨美中药协 (SAPA) 北京, 2004 1
2. 报告内容全球制药界新药开发最新概况新药开发值得注意的走向 Project in-licensing 项目引进 Life Cycle Management (LCM) 产品周期的管理 Outsourcing What Why and (How) ? 2
3. 223236249285296297308337364396010020030040050060019921993199419951996199719981999200020012002p2003pGlobal pharmaceutical sales (US$ billion)4204450100200300400500600Yearp = projectionSource: Sales data for 1992-2001 supplied by IMS Health全球药品销售 1992-2003p3
4. 0608010012014016018020019921993199419951996199719981999200020012002pYearIndexed values (1992 = 100)全球研发费用全球新药上市研发时间 (3 year moving average)全球销售全球销售，研发费用及研发时间和新药上市1992-2002p4
5. Research Late DevelopmentEarly DevelopmentRegulatory assessmentCommercial-isationPre-clinical evaluationClinical evaluation2.9yrs1.5yrs5.7yrsUS FDA: 1.0 yrs EMEA: 1.3 yrs Japanese MHLW: 1.4 yrsDuration (median)Attrition (Number of compounds entering stage per compound launched)911新药 R&D 的过程Target discoveryAssay developmentLead discoveryLead optimisation5
6. 11%16%44%79%0%10%20%30%40%50%60%70%80%90%100%First human dose toMarket 临床一期First patient dose toMarket 临床二期First pivotal dose toMarket 临床三期Submission to market 申报Success rate新药上市的成功机率6
7. 8%13%40%77%34%46%76%88%0%10%20%30%40%50%60%70%80%90%100%First human dose tomarketFirst patient dose tomarketFirst pivotal dose tomarketSubmission to marketSuccess rateChemical entitiesBiotechSuccess rate to market by product type7
8. Termination reasons were provided for 498 of the 538 NASs for which development was terminated between 1999 and 2001.新药开发失败的原因 1999-20018
9. 目前新药开发遇到的困境 R&D成本和风险不断提高 Pipelines becoming thinner　新药项目越来越少 Increasing costs for promotion 　新药上市的费用越来越高 Shorter product life cycles 新药产品周期不断缩短 Rising generic exposure 非专利药抢占市场越来越早9
10. 面对上述的挑战，国际制药界采取了些什么对策？10
11. New Trends in Drug Development目前的新走向 Now the classic drug discovery model is supplemented by　传统的新药开发模式由下面两种方式进行补充 Project in-licensing 项目引进 Life Cycle Management (LCM) 产品周期的管理 Outsourcing 11
12. Many blockbuster drugs are externally sourced许多重磅炸弹都是从其它公司引进的。 Drug Licensee Licensor Launched 2002 sales (mio USD) Paxil GSK Novo Nordisk 1991 2,055 Pravachol BMS Sankyo 1990 2,266 Fosamax Merck Gentili 1993 2,250 Lipitor Pfizer Warner Lamb 1997 7,972 Celexa Forest Labs Lundbeck 1998 1,451 12
13. Revenues from in-licensing are increasing…引进项目的产品销售正在不断提高Share of revenues from in-licensingTop 10 pharmacos* Classified products account for over 70 % of prescription revenues Source: Analyst reports; annual reports; Pharmaprojects database; literature search; McKinsey analysis13
14. Why License in/ Partnering To complement in-house R+D efforts 对公司本身R& D 的补充 To hedge against unexpected product failure or disappointing commercial performance 以防不可预期的产品失败或者不佳的商业业绩 Increasing value of development and marketed products through arrangements with third parties 联和开发和销售　14
15. 项目引进包括哪些方面 In-licensing/Partnering for global development 项目引进与联合开发 Discovery/Research Platform collaborations 研究平台的合作 New drug delivery technologies 新的给药剂型 Co-marketing, co-promotion 联合销售 Manufacturing relationships15
16. 项目引进案例 1999-2002 16
17. Competitors for a given licensing dealPercent of respondentsCompetition for Deals Is Also Increasing5 years agoFewer than 33 to 55 to 8TodaySource: McKinsey survey17
18. Cross Functional Deal TeamStandard Processes and Team WorkResearch and DevelopmentMarketingLegalFinancePatentPreselectionInitialEvaluationFull EvaluationNegotiation18
19. Due DiligenceObtain and review source documentation to provide a reliable evaluation of the: Scientific rationale Preclinical Safety Drug metabolism and pharmacokinetics Chemical and pharmaceutical development Clinical efficacy and safety Regulatory filability Patent status19
20. Large Number of Opportunities Evaluated for Every Deal Closed110 Contacts 65 Early Assessments 17 Initial Evaluations 9 Due Diligences 3 Neogtiations 1 Deal Closed20
21. New Trends in Drug Development目前的新走向 Now the classic drug discovery model is supplemented by　传统的新药开发模式由下面两种方式进行补充 Project in-licensing 项目引进 Life Cycle Management (LCM) 产品周期的管理 Outsourcing 21
22. Augmentin Claritin ZestrilNeurontin Flovent Cipro-floxacinProcrit Lovenox Duragesic DiflucanZocor Pravachol Zithromax ZoloftActos Ambien Paxil NeupogenNorvasc Fosamax Effexor RisperdalSerevent Levaquin AciphexPrevackl Celicept TopamaxGemzar Aricept Singulair Advair/ Seretide*Only drugs with revenues of more than US $100 million per year are included. Why Life Cycle Management ?今后十年内专利过期的新药22
23. Life Cycle Management include Prolonged/Modified release dosage forms Fixed combination with other drugs Enhanced bioavailability New drug delivery principles Targeted or site-specific drug delivery23
24. Global Drug Delivery Market, 2001Total Drug Delivery Systems Market = $42.9 billionsOralInhalationTransdermalParenteralOtherTotal Pharmaceutical Market = $350 billions24
25. 30%11%32%19%40%26%0%10%20%30%40%50%60%70%80%90%100%Major companiesOther companiesAverage percentage of R&D expenditure by company allocated to line extensions199719992001各大公司用于LCM方面的研发费用25
26. Success Story of LCMThe Cardizem Story26
27. Wellbutrin: Growth of a Blockbuster$millionNCE exclusivity expires: 2004 PK half-life: 21 hours 8 days to reach steady-state plasma levelWellbutrin (buproprion HCl) Story (GSK)Wellbtrin SR introducedWellbtrin XL approved27
28. Why Develop Fixed Combination Products? New patent protection Synergistic effects Better therapy Patient compliance Patient convenience Attractive market 28
29. New Trends in Drug Development目前的新走向 Now the classic drug discovery model is supplemented by　传统的新药开发模式由下面两种方式进行补充 Project in-licensing 项目引进 Life Cycle Management (LCM) 产品周期的管理 Outsourcing 29
30. Outsourcing 为什么要 Outsourcing? Capacity Management 人力资源的调控 Technology/Specific expertise 新技术 Strategic 战略上的考虑 Cost control 控制成本 Deadline 时间 30
31. 新药研发的费用分布 200131
32. 010203040506019971998199920002001USANon-core marketsGermanyUKFranceJapanSource of patients for clinical trials 1997-2001Year enrolment completedPercentage of total patients recruited32
33. 5.47.47.99.313.30.02.04.06.08.010.012.014.0 Respiratory (151) Anti-infectives (222) Cardiovascular system(174) Nervous system (383) Anti-cancer (342)Median duration of enrolment period (months)Impact of therapeutic area on enrolment period(n) = number of clinical studies 33
34. 22%0%5%10%15%20%25%30%CMC outsourcing expenditure as apercentage of total CMC expenditure (average) 18%0%5%10%15%20%25%30%Average percentage of R&D FTEs working in CMC Outsourcing of CMC12%0%5%10%15%20%25%30%Average percentage of R&D expenditure invested in CMC Proportion of R&D expenditure spent on CMC activities in 2001Proportion of R&D Full Time Equivalents allocated to CMC in 2001CMC outsourcing expenditure as a percentage of total CMC expenditure34
35. Conclusions 结语开发具有国内或国外水平的新药不仅要依靠企业本身的实力, 还要眼光向外. 有效的引进新项目及专利是目前国际上流行做法. 对已有的上市产品，要利用新技术进行多次开发和产品周期管理(LCM)，以维持和延续产品的寿命和市场份额。一旦中国的产品质量，技术及GMP得已保证， Outsourcing, Generic chemical drug and biotech strategy 中国的制药企业对上述所提的问题都得到加强时，那么中国制药企业的崛起将为时不远… 35
36. Questions??? ???谢谢 !36

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