全球医药产业研究与发展全球医药产业研究与发展的趋势的趋势-资料资料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OutsourcingWhat Why and(How)?2223236249285296297308337364396010020030040050060019921993199420192019201920192019200020192019p 2019pGlobal pharmaceutical sales(US$billion)4204450100200300400500600Yearp=projectionSource:Sales data for 1992-2019 supplied by IMS Health全球药品销售全球药品销售1992-2019p30608010012014016018020019921993199420192019201920192019200020192019pYearIndexed 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全球销售，研发费用及研发时间和新药上市1992-2019p4ResearchLateDevelopmentEarlyDevelopmentRegulatoryassessmentCommercial-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新药新药R&D的过程的过程Target discoveryAssay developmentLead discoveryLead optimisation511%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新药上市的成功机率68%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 entitiesBiotechSuccessratetomarketbyproducttype7Termination reasons were provided for 498 of the 538 NASs for which development was terminated between 2019 and 2019.新药开发失败的原因新药开发失败的原因2019-20198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？10New 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Outsourcing11Many blockbuster drugs are externally sourced许多重磅炸弹都是从其它公司引进的。
DrugLicenseeLicensorLaunched2019sales(mioUSD)PaxilGSKNovoNordisk 19912,055PravacholBMSSankyo19902,266FosamaxMerckGentili19932,250LipitorPfizerWarnerLamb20197,972CelexaForestLabsLundbeck20191,45112Revenues from in-licensing are increasing引进项目的产品销售正在不断提高Shareofrevenuesfromin-licensingTop10pharmacos*Classified products account for over 70%of prescription revenuesSource:Analyst reports;annual reports;Pharmaprojects database;literature search;McKinsey analysis13Why License in/PartneringTocomplementin-houseR+Defforts对公司本身对公司本身R&D的补充的补充Tohedgeagainstunexpectedproductfailureordisappointingcommercialperformance以防不可预期的产品失败或者不佳的商业业绩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 relationships15项目引进案例 2019-2019 16CompetitorsforagivenlicensingdealPercentofrespondentsCompetition for Deals Is Also Increasing5yearsagoFewerthan33to55to8TodaySource:McKinsey survey17CrossFunctionalDealTeamStandard Processes and Team WorkResearchandDevelopmentMarketingLegalFinancePatentPreselectionInitialEvaluationFullEvaluationNegotiation18DueDiligenceObtain and review source documentation to provide a reliable evaluation of the:Scientific rationalePreclinical SafetyDrug metabolism and pharmacokineticsChemical and pharmaceutical developmentClinical efficacy and safetyRegulatory filabilityPatent status19Large Number of Opportunities Evaluated for Every Deal Closed110 Contacts65 Early Assessments17 Initial Evaluations9 Due Diligences3 Neogtiations1 Deal Closed20New 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Outsourcing21AugmentinClaritinZestrilNeurontinFloventCipro-floxacinProcritLovenoxDuragesicDiflucanZocorPravacholZithromaxZoloftActosAmbienPaxilNeupogenNorvascFosamaxEffexorRisperdalSereventLevaquinAciphexPrevacklCeliceptTopamaxGemzarAriceptSingulairAdvair/Seretide*OnlydrugswithrevenuesofmorethanUS$100millionperyearareincluded.Why Life Cycle Management?今后十年内专利过期的新药22Life Cycle Management includeProlonged/Modified release dosage formsFixed combination with other drugsEnhanced bioavailabilityNew drug delivery principlesTargeted or site-specific drug delivery23Global Drug Delivery Market,2019Total Drug Delivery Systems Market=$42.9 billionsOralInhalationTransdermalParenteralOtherTotal Pharmaceutical Market=$350 billions2430%11%32%19%40%26%0%10%20%30%40%50%60%70%80%90%100%Major companiesOther companiesAverage percentage of R&D expenditure by company allocated to line extensions201920192019各大公司用于LCM方面的研发费用25Success Story of LCMTheCardizemStory26Wellbutrin:Growth of a Blockbuster$millionnNCE exclusivity expires:2019nPK half-life:21 hoursn8 days to reach steady-state plasma levelWellbutrin(buproprion HCl)Story(GSK)Wellbtrin SRintroducedWellbtrin XLapproved27Why Develop Fixed Combination Products?NewpatentprotectionSynergisticeffectsBettertherapyPatientcompliancePatientconvenienceAttractivemarket28New 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Outsourcing29Outsourcing为什么要为什么要Outsourcing?1.CapacityManagement人力资源的调控人力资源的调控2.Technology/Specificexpertise新技术新技术3.Strategic 战略上的考虑4.Cost control 控制成本5.Deadline 时间30新药研发的费用分布新药研发的费用分布201931010203040506020192019201920002019USANon-core marketsGermanyUKFranceJapanSource of patients for clinical trials 2019-2019Year enrolment completedPercentage of total patients recruited325.47.47.99.313.30.02.04.06.08.010.012.014.0 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 3322%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 ProportionofR&DexpenditurespentonCMCactivitiesin2019ProportionofR&DFullTimeEquivalentsallocatedtoCMCin2019CMCoutsourcingexpenditureasapercentageoftotalCMCexpenditure34Conclusions 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35Questions?谢谢谢谢!36结束语结束语谢谢大家聆听！谢谢大家聆听！37。