全球医药产业研究与发展的最新趋势

Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,*,*,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,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) ?,2,223,236,249,285,296,297,308,337,364,396,0,100,200,300,400,500,600,1992,1993,1994,1995,1996,1997,1998,1999,2000,2001,2002p,2003p,Global pharmaceutical sales (US$ billion),420,445,0,100,200,300,400,500,600,Year,p = projection,Source: Sales data for 1992-2001 supplied by IMS Health,全球药品销售,1992-2003p,3,0,60,80,100,120,140,160,180,200,1992,1993,1994,1995,1996,1997,1998,1999,2000,2001,2002p,Year,Indexed 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,1992-2002p,4,Research,Late,Development,Early,Development,Regulatory assessment,Commercial-isation,Pre-clinical evaluation,Clinical evaluation,2.9yrs,1.5yrs,5.7yrs,US FDA: 1.0 yrs,EMEA: 1.3 yrs,Japanese,MHLW: 1.4 yrs,Duration,(median),Attrition,(Number of compounds entering stage per compound launched),9,1,1,新药,R&D,的过程,Target discovery,Assay development,Lead discovery,Lead optimisation,5,11%,16%,44%,79%,0%,10%,20%,30%,40%,50%,60%,70%,80%,90%,100%,First human dose to,Market,临床一期,First patient dose to,M,arket,临床二期,First pivotal dose to,M,arket,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 to,market,First patient dose to,market,First pivotal dose to,market,Submission to market,Success rate,Chemical entities,Biotech,Success rate to market by product type,7,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,1999-2001,8,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,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,Outsourcing,11,Many blockbuster drugs are externally sourced,许多重磅炸弹都是从其它公司引进的。,DrugLicenseeLicensorLaunched 2002 sales,(mio USD),PaxilGSKNovo Nordisk19912,055,PravacholBMSSankyo19902,266,FosamaxMerckGentili19932,250,LipitorPfizerWarner Lamb19977,972,CelexaForest LabsLundbeck19981,451,12,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 analysis,13,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,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 relationships,15,项目引进案例,1999-2002,16,Competitors for a given licensing deal,Percent of respondents,Competition for Deals Is Also Increasing,5 years ago,Fewer than 3,3 to 5,5 to 8,Today,Source: McKinsey survey,17,Cross Functional Deal Team,Standard Processes and Team Work,Research and Development,Marketing,Legal,Finance,Patent,Preselection,InitialEvaluation,Full Evaluation,Negotiation,18,Due Diligence,Obtain 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 status,19,Large Number of Opportunities Evaluated for Every Deal Closed,110 Contacts,65 Early Assessments,17 Initial Evaluations,9 Due Diligences,3 Neogtiations,1 Deal Closed,20,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,Augmentin,Claritin,Zestril,Neurontin,Flovent,Cipro-floxacin,Procrit,Lovenox,Duragesic,Diflucan,Zocor,Pravachol,Zithromax,Zoloft,Actos,Ambien,Paxil,Neupogen,Norvasc,Fosamax,Effexor,Risperdal,Serevent,Levaquin,Aciphex,Prevackl,Celicept,Topamax,Gemzar,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,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 delivery,23,Global Drug Delivery Market, 2001,Total Drug Delivery Systems Market = $42.9 billions,Oral,Inhalation,Transdermal,Parenteral,Other,Total Pharmaceutical Market = $350 billions,24,30%,11%,32%,19%,40%,26%,0%,10%,20%,30%,40%,50%,60%,70%,80%,90%,100%,Major companies,Other companies,Average percentage of R&D expenditure,by company allocated to line extensions,1997,1999,2001,各大公司用于,LCM,方面的研发费用,25,Success Story of LCM,The Cardizem Story,26,Wellbutrin: Growth of a Blockbuster,$million,NCE exclusivity expires: 2004,PK half-life: 21 hours,8 days to reach steady-state plasma level,Wellbutrin (buproprion HCl) Story (GSK),Wellbtrin SR,introduced,Wellbtrin XL,approved,27,Why Develop Fixed Combination Products?,New patent protection,Synergistic effects,Better therapy,Patient compliance,Patient convenience,Attractive market,28,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,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,新药研发的费用分布,2001,31,0,10,20,30,40,50,60,1997,1998,1999,2000,2001,USA,Non-core markets,Germany,UK,France,Japan,Source of patients for clinical trials 1997-2001,Year enrolment completed,Percentage of total patients recruited,32,5.4,7.4,7.9,9.3,13.3,0.0,2.0,4.0,6.0,8.0,10.0,12.0,14.0,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,33,22%,0%,5%,10%,15%,20%,25%,30%,CMC outsourcing expenditure as a,percentage of total CMC expenditure (average),18%,0%,5%,10%,15%,20%,25%,30%,Average percentage of R&D FTEs working in CMC,Outsourcing of CMC,12%,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 2001,Proportion of R&D Full Time Equivalents allocated to CMC,in 2001,CMC outsourcing expenditure,as a percentage of total,CMC expenditure,34,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,Questions?,?,谢谢,!,36,