全球医药产业研究与发展的最新趋势(1).pptxVIP

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, 20041 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 223236249285296297308337364396010020030040050060019921993199419951996199719981999200020012002p2003pGlobal pharmaceutical sales (US$ billion)4204450100200300400500600Yearp = projectionSource: Sales data for 1992-2001 supplied by IMS Health全球药品销售 1992-2003p3 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 Research Late DevelopmentEarly DevelopmentRegulatory assessmentCommercial-isationPre-clinical evaluationClinical evaluation2.9yrs1.5yrs5.7yrsUS FDA: 1.0 yrsEMEA: 1.3 yrs Japanese MHLW: 1.4 yrsDuration(median)Attrition(Number of compounds entering stage per compound launched)911新药 RD 的过程Target discoveryAssay developmentLead discoveryLead optimisation5 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 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 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 目前新药开发遇到的困境RD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 面对上述的挑战，国际制药界采取了些什么对策？10 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Outsourcing11 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