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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)北京,20192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•Projectin-licensing项目引进•LifeCycleManagement(LCM)产品周期的管理•OutsourcingWhatWhyand(How)?3223236249285296297308337364396010020030040050060019921993199420192019201920192019200020192019p2019pGlobalpharmaceuticalsales(US$billion)4204450100200300400500600Yearp=projectionSource:Salesdatafor1992-2019suppliedbyIMSHealth全球药品销售1992-2019p40608010012014016018020019921993199420192019201920192019200020192019pYearIndexedvalues(1992=100)全球研发费用全球新药上市研发时间(3yearmovingaverage)全球销售全球销售，研发费用及研发时间和新药上市1992-2019p5ResearchLateDevelopmentEarlyDevelopmentRegulatoryassessmentCommercial-isationClinicalevaluation2.9yrs1.5yrs5.7yrsUSFDA:1.0yrsEMEA:1.3yrsJapaneseMHLW:1.4yrsDuration(median)Attrition(Numberofcompoundsenteringstagepercompoundlaunched)911新药R&D的过程TargetdiscoveryLeaddiscoveryLeadoptimisation611%16%44%79%0%10%20%30%40%50%60%70%80%90%100%FirsthumandosetoMarket临床一期FirstpatientdosetoMarket临床二期FirstpivotaldosetoMarket临床三期Submissiontomarket申报Successrate新药上市的成功机率78%13%40%77%34%46%76%88%0%10%20%30%40%50%60%70%80%90%100%FirsthumandosetomarketFirstpatientdosetomarketFirstpivotaldosetomarketSubmissiontomarketSuccessrateChemicalentitiesBiotechSuccessratetomarketbyproducttype8战略考虑22.9%毒性23.5%临床安全12.0%临床疗效21.9%其他19.7%Preclinicalefficacy2.8%PreclinicalPk/bioavailability2.2%Formulation1.4%PatentorCommerciallegal1.0%Regulatory0.6%Other5.4%ClinicalPk/bioavailability6.2%Terminationreasonswereprovidedfor498ofthe538NASsforwhichdevelopmentwasterminatedbetween2019and2019.新药开发失败的原因2019-20199目前新药开发遇到的困境•R&D成本和风险不断提高•Pipelinesbecomingthinner新药项目越来越少•Increasingcostsforpromotion新药上市的费用越来越高•Shorterproductlifecycles新药产品周期不断缩短•Risinggenericexposure非专利药抢占市场越来越早10面对上述的挑战，国际制药界采取了些什么对策？11NewTrendsinDrugDevelopment目前的新走向•Nowtheclassicdrugdiscoverymodelissupplementedby传统的新药开发模式由下面两种方式进行补充•Projectin-licensing项目引进•LifeCycleManagement(LCM)产品周期的管理•Outsourcing12Manyblockbusterdrugsareexternallysourced许多重磅炸弹都是从其它公司引进的。•DrugLicenseeLicensorLaunched2019sales(mioUSD)•PaxilGSKNovoNordisk19912,055•PravacholBMSSankyo19902,266•FosamaxMerckGentili19932,250•LipitorPfizerWarnerLamb20197,972•CelexaForestLabsLundbeck20191,45113Revenuesfromin-licensingareincreasing…引进项目的产品销售正在不断提高35-4530*24*199219972002EShareofrevenuesfromin-licensingTop10pharmacos*Classifiedproductsaccountforover70%ofprescriptionrevenuesSource:Analystreports;annualreports;Pharmaprojectsdatabase;literaturesearch;McKinseyanalysis14WhyLicensein/PartneringTocomplementin-houseR+Defforts对公司本身R&D的补充Tohedgeagainstunexpectedproductfailureordisappointingcommercialperformance以防不可预期的产品失败或者不佳的商业业绩Increasingvalueofdevelopmentandmarketedproductsthrougharrangementswiththirdparties联和开发和销售15项目引进包括哪些方面•In-licensing/Partneringforglobaldevelopment项目引进与联合开发•Discovery/ResearchPlatformcollaborations研究平台的合作•Newdrugdeliverytechnologies新的给药剂型•Co-marketing,co-promotion联合销售•Manufacturingrelationships16项目引进案例2019-2019CompanyTotal$MMDealBristol-MyersSquibb2,000Equitystakeof$1bn&$1bncashforco-development&co-promotionofIMC-225Novartis1,600PurchasefromGSKofFamvirandDenavirRoche1,100PurchasefromGSKofKytrilAventis450MilestonestoMillenium+profitshareBayer435InvestmentandmilestonesforMilleniumLilly250Cash/equity/loan/milestones/royaltiestoISISforISIS3521andantisensediscoverycollaborationPharmacia230MilestonestoCelltechforCDP-870Schering-Plough189VascularprotectionagentsfromAtheroGenicsGenentech185Cash/equity/milestonestoOSIPfizer155Cash/milestonestoOnyxLilly179Investment/milestonesforICOSCialisPharmacia62MilestonestoCambridgeAntibodyTechnology17CompetitorsforagivenlicensingdealPercentofrespondentsCompetitionforDealsIsAlsoIncreasing673305yearsagoFewerthan33to55to8Today05644Source:McKinseysurvey18CrossFunctionalDealTeamStandardProcessesandTeamWorkResearchandDevelopmentMarketingLegalFinancePatentPreselectionInitialEvaluationFullEvaluationNegotiation19DueDiligenceObtainandreviewsourcedocumentationtoprovideareliableevaluationofthe:•Scientificrationale•PreclinicalSafety•Drugmetabolismandpharmacokinetics•Chemicalandpharmaceuticaldevelopment•Clinicalefficacyandsafety•Regulatoryfilability•Patentstatus20LargeNumberofOpportunitiesEvaluatedforEveryDealClosed•110Contacts•65EarlyAssessments•17InitialEvaluations•9DueDiligences•3Neogtiations•1DealClosed21NewTrendsinDrugDevelopment目前的新走向•Nowtheclassicdrugdiscoverymodelissupplementedby传统的新药开发模式由下面两种方式进行补充•Projectin-licensing项目引进•LifeCycleManagement(LCM)产品周期的管理•Outsourcing22131318311528151623010203040200220032004200520062007200820092010YearUS$billions•Augmentin•Claritin•ZestrilNeurontinFloventCipro-floxacinProcritLovenoxDuragesicDiflucanZocorPravacholZithromaxZoloftActosAmbienPaxilNeupogenNorvascFosamaxEffexorRisperdalSereventLevaquinAciphexPrevacklCeliceptTopamaxGemzarAriceptSingulairAdvair/Seretide•*OnlydrugswithrevenuesofmorethanUS$100millionperyearareincluded.WhyLifeCycleManagement?今后十年内专利过期的新药23LifeCycleManagementinclude–Prolonged/Modifiedreleasedosageforms–Fixedcombinationwithotherdrugs–Enhancedbioavailability–Newdrugdeliveryprinciples–Targetedorsite-