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首页 2010年上海--新药研发立项与专利策略专题培训

2010年上海--新药研发立项与专利策略专题培训.pdf

2010年上海--新药研发立项与专利策略专题培训

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2010-07-10 0人阅读 举报 0 0 暂无简介

简介:本文档为《2010年上海--新药研发立项与专利策略专题培训pdf》,可适用于自然科学领域

年新药研发立项与专利策略专题培训年月日中国·上海华美达中土酒店上海厅培训议程::培训报到第一天::互换“锁钥”角色合成受体作为潜在药物的研究瑞士罗氏(中国)研发中心首席科学官副总裁张明强::休息::如何进行生物技术药物的研发康弘药业集团副总裁俞德超::午餐::药品研发及营销的专利风险规避国家知识产权战略专题评审专家中国药科大学教授周和平::休息::中国制药企业专利战略与实际案例解读北京中医药大学讲师刘伟::专利法综述及药物研发的专利战略美国艾克信事务所(Axinn,VeltropHarkrider)专利法律师博士陈倜第二天::以临床应用价值与治疗领域市场竞争力为导向的新药立项评估上海医药工业研究院信息中心项目总监芮伟::休息::专利到期药品的监测与分析上海医药工业研究院信息中心主任钟倩::午餐::购并产品价值评估方法与新资本介入医药行业的机会分析北京博斯特投资公司总监王立峰::休息::新药立项的药品专利及中药品种保护查询上海医药工业研究院信息中心信息研究员张修宝::有的放矢追踪研发趋势动态监测目标领域新品种抗细菌药物综述及潜力品种点评上海医药工业研究院信息中心信息研究员王彩娟姓名(Name):张明强单位(Affiliation):罗氏研发(中国)有限公司称谓(Title):副总裁首席技术执行官电话(Tel):Email:mingqiangzhangrochecom简介(Biography):张明强现为罗氏研发(中国)有限公司首席技术执行官兼副总裁。他是将诸如超分子化学和合成生物学等新型技术应用到新药发明中的创始者之一。在他的带领下有多个新发明的药物已获批上市或进入临床开发,其中包括用于中枢神经系统、癌症、炎症与感染性疾病治疗的数枚新药。张博士于年获英国皇家化学会(RSC)颁发MalcolmCampbell纪念大奖年获Nexxus生命科学创新奖以表彰他及相关人员开发的首个获批用于临床的新型肌松药逆转剂Sugammadex(Bridion®,MerckCo)。年张博士在比利时安特卫普大学(UniversityofAntwerp)获药物化学博士学位年于荷兰阿姆斯特丹自由大学从事博士后研究。在莱顿阿姆斯特丹药物研究中心(LeidenAmsterdamCenterforDrugResearch)任副教授若干年后(~年)他加入了荷兰跨国药企欧加农担任药物化学部主管。~年张博士在英国Shire制药集团任药物化学部总监。年他加入英国剑桥生物技术有限公司(BioticaTechnology)最初出任研究副总裁随后又晋升为研究与开发高级副总裁(~年)他在将公司转型做新药研发以及在与惠氏制药(现为辉瑞)和葛兰素史克建立两大重要研发合作伙伴关系中起到决定性的贡献。同时他还是ViroChem制药公司的创始人之一(年)(该公司于年被Vertex收购)。报告题目(Topic):互换“锁钥”角色合成受体作为潜在药物的研究关键词(Keyword):主客体相互作用螯合剂螯合作用解毒作用抗菌的抗癌的抑制蛋白质相互作用摘要(Abstract):目前大多已知的、成功的分子干预疗法依赖于以生物大分子(例如:某种受体、酶、离子通道等)为靶向的小分子配体(即药物)。丛超分子化学角度来讲现有的大多数治疗药物是含有发散性相互作用基团的“客体”分子它们的治疗目标即为含有汇聚性相互作用基团的“主体”分子。对于干预治疗或新药发现很少采用主体分子(或合成受体、螯合剂)靶向客体分子。主体分子(或合成受体)作为治疗方法难以开发的原因有多个。首先这些主体分子的化学与合成通常要比客体小分子的更为复杂。其次设计出对客体小分子有足够亲和力、能与生物受体相竞争的主体分子是具有高度挑战性的。第三主体分子中有许多官能团且分子尺寸大通常其物理化学性质不利于口服吸收。用于分子设计的、所谓的“五规则”在新药发现中的广泛应用意味着分子量大于Da的这些分子是不受重视的。本次讲座将着重突出开发合成受体(包括主体分子与螯合剂)作为潜在治疗方法方面的最新进展。将以首个用于手术后肌肉功能恢复的新型合成受体Sugammadex(Bridion®,MerckCo)为例子进行讲解同时还涉及抗毒剂、抗菌剂与抗癌新药发现领域中的其他一些研发案例。通过本次讲座出席者将可以了解到以下几方面内容:新药发现中“锁钥”概念的新内涵先导化合物优化中热动力学分析法的应用以及在开发候选药物选择中的决策制定。SynthetichostmoleculesastherapeuticagentsMingQiangZhangVPCTO,RocheRDCentre(China)ThediscoveryofsugammadexOrganonChemistsOrganonLabsNMBAChAChEcholineacetatenAChRNMBNMBblocksthebindingofAChinducedsignaltransmission,andhenceresultsinmusclerelaxationNMBsareusedclinicallyinSurgery(paralysisofskeletalmuscles)Intensivecare(assistmechanicalventilation)Emergency(intubation)Neuromuscularpharmacologyinanaesthesia()NOOONONOONOOMeOMeOMeOMeOOMeOMeOMeOMeHAcONOAcNNHOHOAcONsuxamethonium(depolarisingNMB!)atracuriumpancuroniumrocuroniumExamplesofclinicallyusedneuromuscularblockersTheneedforNMBreversal•Tospeeduprecoveryfromneuromuscularblockattheendofsurgeryorintensivecare–>ofelectivesurgerywasperformedasdayproceduresintheUKand>intheUSA–Hospitalcost:$,dayforallmedicalconditions$,dayinanICU(USA)USAexpenditureforcriticalcaremedicine~$billion(or~ofGDP~ofnationalhealthcareexpenditure)•Topreventresidualneuromuscularblockandpostoperativecomplications–Incidenceofresidualparalysis:~surgicaloutpatientsinpatients–Incidenceofpostoperativecomplications:~ofallpatients,uptoinolderpatients,ofwhichlifethreatening(egpulmonarycomplications)NMBAChAChEcholineacetatenAChRAChNeuromuscularpharmacologyinanaesthesia()AChEinhibitorseg,neostigmineNONOOHNneostigamineedrophonium•Producemajorcardiovascularsideeffects(egarrhythmias,hypotension)duetoactivationofmAChR•MustbeusedincombinationwithmAChRantagoniststoprotecttheheart,eg,atropine•Residualneuromuscularactivitymustbepresent(eg,>twitchactivity)beforereversal•Can’tbeusedtoreversedepolarisingRA,egsuxamethonium•Notsuitableinreversing‘profoundblock’BioorgMedChemLett(),BioorgMedChemLett(),BioorgMedChemLett(),LimitationsofcurrentlyusedNMBreversalagentsNOMeOMeONMeOMeOSOONOdonepezilOrgOrgcodeED,µmolkgmaxreversalMAP,max∆HR,max∆Vagus,max∆donepezilOrgBioorgMedChemLett(),FromdonepeziltopotentialnewNMBreversalagentsNMBAChAChEcholineacetatenAChRAChSynthHostExogenoushostmoleculeencapsulatestheNMBwithoutinterferingthecholinergicsystem,hencenoAChrelatedsideeffects!SyntheticreceptorsasNMBreversalagentsCyclophanesasthesyntheticreceptors•EC(vspancuronium):µM•poorHOsolubility,toxic!OOOOCOHCOHHOCHOCHAcONOAcNpancuroniumBioorgMedChemLett,,•alibraryof,•Ka~,Mtodabsylpancuronium•Poorsolubility!OONHNHONHOHOCNHNHONOONHONHOHOCOCOHOCyclic(pseudo)peptidesOOHHHHHHHOHOOHHOOHOHOHOHOOOOOOOOOOOOOHOHOHOHOHOHOHOHOHOHOHOHOHOHOHOHOHOHHydrophobiccavityHydrophilicexterior()nn=,αCDn=,βCDn=,γCDExpOpinTherPatents(),Cyclodextrins(CDs):‘Biocompatible’hostmolecules•complexwithguest(eg,steroids)•HOsoluble•biologicallyinactive(noCVeffects)BrNOHOHOAcNRocuroniumbromideCDsasNMBreversalagentsInvitroreversalofrocuroniumbynaturalCD’sCDCavitydiameter,ÅHeightoftorus,ÅEC(µM)MEANSEMmaxreversal()MEANSEM(atconcµM)α±>±()β±>±()γ±±±()Hostmoleculedesign:Sizematters~Å~ÅÅHostmoleculedesign:Sizematters‘WrappinguptheLegs’–Modelingupsidedown!•Fullencapsulationofsteroidalrings:–extensionofcavitydepthofγCD(Åto~Å)–increaseoftotalhydrophobicinteractionarea•ElectrostaticinteractionwithN:–COOattherimofthecavity–maintainHOsolubility!Hostmoleculedesign:StrategiesOOOOOOOOOOOOOHOHOHOHOHOHOHOHOHOHOHOHOHOHOHOHOHOH()nmostbasicmostacidicmosthindered•SimilarreactivityofallOH’s(mixtureofisomers)•Presenceofcavityinterferingwith‘normal’reactivityChemicalmodificationofCD’sOOSOHOHOOnNaInvitroMHDvsµMrocuroniumnMaxReversal,EC,uM(concuM)()()()()()JMedChem(),DiscoveryofSugammadex:SARchainlengthcompoundKaMN∆GkJmol∆HkJmol∆SJmolKOOSOOHONaHOEOOSOOHONaHOEOOSOOHHOONaEOrgLett(),Sugammadex‘Cavitydepth’oncomplexationthermodynamicsOOAOHOHAMaxReversal,EC,uM(concuM)()()SOONaSOHInvitroMHDvsµMrocuroniumJMedChem(),DiscoveryofSugammadex:SARacidvsneutralCyclodextrinNKM∆GkJmol∆HkJmol∆SJmolKOOSOOHHOOxOOSOOHHOHxJMedChem(),Electrostaticinteractiononcomplexationthermodynamics•WhatareNMBs•TheneedforNMBreversal•LimitationsofthepreviousNMBreversalagents•TheconceptofhostmoleculesasRAs•Synthesisstructureactivityrelationships•SugammadexasanovelRA•LessonslearnedAgenda•Nicotinicreceptorantagonistsattheneuromuscularjunction•WidelyusedduringanesthesiatofacilitateendotrachealintubationandsurgicalaccesstobodycavitiesNMBs=neuromuscularblockers(musclerelaxants)Depthofthecavityenoughtoencapsulateallringsofthesteroid~ÅJMedChem(),CrystalstructureofSugammadexOrgwithterminalOHOrg(Sugammadex)withterminalCOOJMedChem(),ElectricrepulsiononcavityopeningRocuronium:AllylCαC:ÅCC:ÅSugammadex:COCOH:ÅSCOH:ÅOHmorphexposedtoHOAngewChemIntEd(),Crystalstructureofsugammadexrocuroniumcomplextime(sec)Force(N)salinemgkgOrgrocuroniumstopinfusionJMedChem(),ReversalofrocuroniuminducedneuromuscularblockinanaesthetisedcatsDataobtainedinanaesthetisedcatsCVeffectsduringreversalofrocuroniumbySugammadextime(min)recoveryspontaneous(n=)neostigmineatropine(n=)mgkgOrg(n=)AngewChemIntEd(),Reversalofrocuroniumblock()inmonkeysbySugammadex‘Sugammadex:Anothermilestoneinclinicalneuromuscularpharmacology’,AnesthAnalg,:byDrMohamedNaguib,Professor,DepartmentofAnesthesiologyandPainMedicine,TheUniversityofTexas,MDAndersonCancerCenter‘Sugammadex:Anopportunitytochangethepracticeofanesthesiology’,AnesthAnalg,:byDrRonaldDMiller,ProfessorandChair,DepartmentofAnesthesiaandPerioperativeCare,UCSF‘Sugammadex:Arevolutionaryapproachtoneuromuscularantagonism’,Anesthesiology,:byDrAaronFKopman,Professor,ViceChairandDirectorofResearch,DepartmentofAnesthesiology,NewYorkMedicalCollege,NY‘Cyclodextrinmediatedreversalofneuromuscularblockispotentiallythegreatestadvanceinneuromuscularpharmacologyinthelastyears!’DrJamesECaldwell,ProfessorofAnesthesiaandPerioperativeCare,UCSF(http:wwwasahqorgNewsletterswhatsNewhtml)‘Simplyput,I’minlovewiththisproductIcan’twaittocompletemyallotmentofpatientsinthisstudysoIcanstartusingthisdrugwithmyotherpatientsInmyopinion,thisdrughasthepotentialtocompletelyrevolutionizeanesthesiologyasit’spractisedtoday’ScottGroudine,MD,AssistantProfessorofAnesthesiologyandSurgery,AlbanyMedicalCenterTheRoyalSocietyofChemistryMalcolmCampbellMemorialPrizehasbeenawardedtoateamofOrganonresearchersinNewhouse,Scotland,foritsgroundbreakingworkonthenewanaesthesiadrugsugammadex(http:wwwrscorgAboutUsNewsPressReleasesOrganonAwardasp)Sugammadex:ArevolutionarydrugSugammadex:Arevolutionarydrug•Lateralthinking–Especiallyimportantfor‘experienced’medicinalchemistsit’salwayseasiertokillanideathantoproposenewone•HavetheguttotackledifficultchemistryguidedbySAR(ZhangMQ:DrugsFut,():)•Solubilityimportantevenforhostmolecules•Reliablepredictivepharmacologicalmodels–Invitro–invivointerspeciescorrelation–Chemicalmechanismofaction•Smallsynthetichostmoleculesaddacompletelynewdimensionfordrugdiscovery–Mostdrugdiscoverymedicinalchemistrytargetsmallmolecules(‘guestmolecules’)tobindtomacromolecules(egreceptors,enzymes,ionchannelsor‘hostmolecules’)–Sugammadexrepresentsthefirstexampleofmanmade‘hostmolecule’(receptor)totargetasmall‘guestmolecule’fortherapeuticinterventionLessonslearnedWeInnovateHealthcare姓名(Name):俞德超单位(Affiliation):成都康弘生物科技有限公司称谓(Title):总经理电话(Tel):Email:michyahoocom简介(Biography):中国科学院分子遗传学博士美国加州大学博士后。先后任美国Calydon生物制药公司主管新药研发副总裁美国CellGenesys生物制药公司首席科学家美国AppliedGenetics生物制药公司资深副总裁、美国WelchInstitute生物制药公司主要创始人、首席科学官、中美合资康弘赛金药业有限公司董事、首席执行官。现任全国生化检测技术委员会副主任委员、生物大分子蛋白药物四川省重点实验室主任、康弘生物科技有限公司董事总经理、康弘药业集团国家级新药开发中心“国家认定企业技术中心”主任、康弘药业集团副总裁。利用基因工程手段开发抗肿瘤药物新领域-肿瘤病毒疗法(CancerVirotherapy)的主要创始人之一也是多项美国专利的发明人同时还领导了六种创新药物的开发并在多个国内外刊物上发表了多篇SCI论文和专著以及是八种国际一流生物医学杂志刊物的审稿人并被邀请在世界各地作学术报告逾场。此外还主持参与了项课题、独立主持了项国家“重大新药创制”科技重大专项和一项‘国家创新能力建设’专项参与承担了项国家“重大新药创制”综合性新药研究开发技术大平台和三项国家计划课题。报告题目(Topic):HowtoBuildaBiologicsPipeline(如何进行生物技术药物的研发)关键词(Keyword):Biologics、Pipeline、Research摘要(Abstract):随着人类对生物技术领域的不断探索和开发生物技术行业已呈现出产业化明显加快、规模迅速扩张、新药开发热情高涨等特点因此如今的生物技术药物正在快速崛起并有着大幅增长的发展趋势而生物医药公司的总市值也已超过了传统制药公司使得整个生物产业都焕发出了勃勃生机。俞博士多年专注于生物技术药物领域的研发并且硕果累累。而作为国内外多家公司的研发高管他还颇具卓越的战略思维和丰富的实践经验。本次会议他将就自己对生物行业独特的感悟和见解结合其多年的研发和战略经验以多家生物公司的研发设计为案例与参会者分享他基于生物技术领域的研发思路和观点。HowtoBuildaBiologicsPipelinePipelineֲֲᖋ䍙म຿ֲֲᖋ䍙म຿៤䛑ᒋᓬ⫳⠽⾥ᡔ᳝䰤݀ৌ⌭∳໻ᄺ,ಯᎱ໻ᄺEmail:michyahoocomyBiotechnologygyHealthMedicalFoodAgricultureEndingHungerFightingDiseaseIndustrialEnvironmentalReducingPollutionFoodAgriculture:FeedingtheWorldggmillionchildrenunderdieeachmillionchildrenunderdieeachyearofhungerrelatedcausesillilhtdmillionpeoplegohungrytodayWldltifbillibWorldpopulationofbillionbyFoodAgriculture:FeedingtheWorldWorld�Goldenrice(VitaminA)�Goldenrice(VitaminA)�millionfarmersgrowbiotechcropsIndustrialBiotech:ReducingPollutionPollutionCellulosicEthanolCellulosicEthanolRenewableEnergyLCOffilflLessCOfromfossilfuelsMoreUSenergyindependenceIndustrialBiotech:ReducingPollutionPollutionCellulosicEthanolBioplasticsMaterialsCleanerIndustrialProcessesHealthMedical:FightingDiseaseggTherapiesVaccinesTherapiesVaccinesProductsinClinicalTrialsCancerAutoimmuneDisordersHIVAIDSHeartDiseaseAlzheimer’sMultipleSclerosispDiabetesInfluenzaSlayingtheCostDragonyggHospitalCare:$Bp$DoctorClinical:$BPrescriptionDrugs:$BDiabetes:$BCancer:$BCardiovasculardisease:$BPersonalizedMedicine•PredictivePersonalize•Personalized•Preemptive•Screeningdiagnostics•ProphylactiProphylactictreatmentteatetBiotechnologyIndustrygyy•,biosciencebusinesses•milliondirectjobs•millionadditionaljobsj•$,averageannualwage•$aboveprivatesector•$,aboveprivatesectoraverageBusinessModel•Investorbackedstartups•LongdevelopmentLongdevelopmenttimeRltl•Regulatoryapproval•FundingfutureRDgUSBusinessEnvironmentConduciveToBiotechnologyCitlkt•Capitalmarkets•Legalgregulatory•Patentprotection•Patentprotection•Education•FacilitiesFDADrugApprovalsgppNatureReviewsDrugDiscovery:,TopBiologicsTopBiologicspgpgPipelineReviewcom,March,���������ᑈܼ⧗ए䫔ଂᥦৡࠡकϾ㥃ᑈܼ⧗ए䫔ଂᥦৡࠡकϾ㥃કᥦৡѻક݀ৌ⊏⭫Ѯ㉏ᡔᴃ䫔ଂ(ⱒϛ㕢ܗ)LosecPrilosecAstraZenecaᡫ䝌㥃ᡫ⑗⭵㥃ᇣߚᄤ,ZocorMerckCoSanofiAtiᡫ催㸔㛖⮛ᇣߚᄤ,AventisLipitorPfizerAstellasᡫ催㸔㛖⮛᠟ᗻ࣪ᄺ,EpogenProcritJJAmgenᡫ䋿㸔㥃䞡㒘ѻક,pgg,NorvascPfizer䩭ᣂᡫࠖ䫔ߚᄤ,PravacholBMSDaiichiSankyoᡫ催㸔㛖⮛ᇣߚᄤ,ProzacEliLillyᡫᡥ䚕ᇣߚᄤ,ZyprexaEliLillyᡫ㊒⼲⮙ᇣߚᄤ,SeroxatPaxilIRGlaxoSmithKlineᡫᡥ䚕ᇣߚᄤ,ClaritinScheringPloughᡫ㒘㛎ᇣߚᄤ,ggEPVantage���������ᑈܼ⧗ए䫔ଂᥦৡࠡकϾ㥃ᑈܼ⧗ए䫔ଂᥦৡࠡकϾ㥃કᥦৡѻક݀ৌ⊏⭫Ѯ㉏ᡔᴃ䫔ଂ(ⱒϛ㕢ܗ)LipitorPfizerAstellasAlmirallᡫ催㸔㛖⮛᠟ᗻ࣪ᄺ,PlavixBMSSanofiAventis㸔ᇣᵓ๲Ⅺᡥࠊࠖᇣߚᄤ,AdvairGlaxoSmithKline݊Ҫᬃ⇨ㅵᠽᓴ㥃ᇣߚᄤ,EnbrelWyethAmgenTakeda݊Ҫᡫ亢⑓ᗻ݇㡖♢䞡㒘ѻક,DiovanNovartisIpsen㸔ㅵ䫕㋻㋴IIᣂᡫࠖᇣߚᄤ,RituxanRocheᡫ㚓⯸ᮄ⫳ऩᡫऩᡫ,RemicadeSGPJJMitsubishiTanabe݊Ҫᡫ亢⑓ᗻ䗯㸫ⴐऩᡫ,NexiumAstraZenecaᡫ䝌㥃ᡫ⑗⭵㥃᠟ᗻ࣪ᄺNexiumAstraZenecaᡫ䝌㥃ᡫ⑗⭵㥃᠟ᗻ࣪ᄺ,EpogenProcritJJAmgenKirinᡫ䋿㸔䞡㒘ѻક,AvastinRocheᡫ㚓⯸ᮄ⫳ऩᡫऩᡫAvastinRocheᡫ㚓⯸ᮄ⫳ऩᡫऩᡫ,EPVantage���������ᑈܼ⧗ए䫔ଂᥦৡࠡकϾ㥃ᑈܼ⧗ए䫔ଂᥦৡࠡकϾ㥃કᥦৡѻક݀ৌ⊏⭫Ѯ㉏ᡔᴃ䫔ଂ(ⱒϛ㕢ܗ)()AvastinRocheᡫ㚓⯸ᮄ⫳ऩᡫऩᡫ,HumiraAbbottEisai݊Ҫᡫ亢⑓݇㡖♢ऩᡫ,RituxanRocheᡫ㚓⯸ᮄ⫳ऩᡫऩᡫ,EnbrelWyethAmgenTake݊Ҫᡫ亢⑓ᗻ݇㡖♢䞡㒘ѻક,ygdaLantusSanofiAventisᡫ㊪ሓ⮙䞡㒘ѻક,HerceptinRocheᡫ㚓⯸ᮄ⫳ऩᡫऩᡫ,pᡫ㚓⯸ᮄऩᡫऩᡫ,CrestorAstraZenecaᡫ催㸔㛖ᇣߚᄤ,SpirivaBoehringerIngelheimᡫ㚚⺅㛑㥃⠽ᇣߚᄤ,RemicadeSGPJJMitsubishiTanabe݊Ҫᡫ亢⑓݇㡖♢ऩᡫ,GlGliNti݊Ҫ㒚㚲ᡥࠊࠖᇣߚᄤGleevecGlivecNovartis݊Ҫ㒚㚲ᡥࠊࠖᇣߚᄤ,EPVantageܼܼ⧗ए㥃Ꮦഎӑ乱๲䭓ᚙމܼ⧗ए㥃Ꮦഎӑ乱๲䭓ᚙމ䫔ଂߚᵤ˄ᣝᡔᴃߚ㉏˅䫔ଂᣝᡔᴃߚ㉏�ғ㕢ܗ�������������⫳⠽ᡔᴃ䫔ଂߚᵤ˄ᣝᡔᴃߚ㉏˅⫳⠽ᡔᴃ�����������Ӵ㒳㥃⠽������������ᘏ໘ᮍ䴲໘ᮍ㥃⠽䫔ଂ������������ᘏ໘ᮍ䴲໘ᮍ㥃⠽䫔ଂ䫔ଂᥦৡࠡ䫔ଂᥦৡࠡ������Ͼ㥃Ͼ㥃કЁ⫳⠽㥃ⱘ↨՟㥃ⱘ↨՟⫳⠽ᡔᴃ���������Ӵ㒳㥃⠽���������EPVantageܼܼ⧗ए㥃Ꮦഎӑ乱๲䭓ᚙމܼ⧗ए㥃Ꮦഎӑ乱๲䭓ᚙމ䫔ଂᣝᡔᴃߚ㉏�ғ㕢ܗ�������������䫔ଂߚᵤ˄ᣝᡔᴃߚ㉏˅⫳⠽ᡔᴃ�����������Ӵ㒳㥃⠽������������݊Ҫ�����������ᘏ໘ᮍ䴲໘ᮍ㥃⠽䫔ଂ������������໘ᮍ�䴲໘ᮍ㥃Ё⫳⠽㥃ⱘ↨՟⫳⠽ᡔᴃ��������⫳⠽ᡔᴃ��������Ӵ㒳݊Ҫ᳾ߚ㉏���������䫔ଂᥦৡࠡ䫔ଂᥦৡࠡ������Ͼ㥃Ͼ㥃કЁ⫳⠽㥃ⱘ↨՟⫳⠽ᡔᴃ���������Ӵ㒳㥃⠽���������ಓ๞ྤྐ٤ഓᆙೇᄔྸбڶҎහᄥྐ٤ഓಓ๞ྤྐ٤ഓᆙೇᄔྸбڶҎහᄥྐ٤ഓ$$$TopUSPharma$$($billion)$$TotalMarketCapTotalBiotechMarketCap$$T$$ecebAprunugOctecebAprunugOctecebAprunugOctecebAprunugOctecebDecFebApJunAugOcDecFebApJunAugOcDecFebApJunAugOcDecFebApJunAugOcDecFebಓ๞Сྜ֟ႺಓݯϑϑThenСႺϑϑNowThen�Title:AttheCrossroadsNow�Title:AChninPrriptin�Title:AttheCrossroads�Industrysize:Companies�bli�Title:AChangingPrescription�Industrysize:companies�public�MarketCap:$B�Industrysize:companies�publicp$�Sale:$B�MarketCap:$B(USonly)�Sale:$BСଶཙ֟഑াСଶཙ֟഑া�Mtֿႏྐ�Metoo:ֿႏྐ�Mebetter:ྐ໒̝ۤ௦໿ပൎ؟౟ēய೓ᅥॆͬܙ�Menew:ݮဟ໭ԅ֟ຣࢗ֟ѻԅ໭ྐďfirstin�Menew:ݮဟ໭ԅ֟ຣࢗ֟ѻԅ໭ྐďfirstinclassĐ“MeToo”഑াMeToo഑া�Strategy:genericdrugs,biosimilarsfollowons�Strategy:genericdrugs,biosimilarsfollowons�Advantage:highsuccessrate,relativelysmallinvestment�Disadvantage:highcompetitionandlowprofit�Disadvantage:highcompetitionandlowprofitmarginGenericDrugsֿႏྐGenericDrugsֿႏྐ�Genericsusethesameingredientsworkthesamein�Genericsusethesameingredients,wor

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