生物制藥行業(yè)展望2024

領(lǐng)袖視角1領(lǐng)袖視角生物制藥行業(yè)展望2024XBI指數(shù)價格*2502502001501001181001188779020192020202120222023**100--508779020192020202120222023**IPO融資^21820021820018515010010050501730202120222023**風(fēng)險投資250203200150155150100風(fēng)險投資25020320015015515010050020192020202120222023**100500總并購交易價值 200150100 6056 305420192020202120222023***2023年之前的XBI指數(shù)價格截至年底**2023年風(fēng)險投資價值于2023年12月15日更新（來自Pitchbook其他指標(biāo)則于2023年11月30日更新（來自CapitalIQ因此可能會低估最終年度融資價值^2023年不包括KenvueIPO，籌資總額約為38億美元注釋：IPO=首次公開募股；VC=風(fēng)險投資；XBI=SPDR標(biāo)普生物科技；美國IPO和并購交易包括CapitalIQ中從行業(yè)分類中選擇的已宣布和已完成的交易，這些行業(yè)分類包括制藥、生物技術(shù)和生命科學(xué)、生物技術(shù)、制藥、醫(yī)藥產(chǎn)品、藥品研究與開發(fā)；PitchBook數(shù)據(jù)未經(jīng)PitchBook分析師審核資料來源：PitchBook（風(fēng)險投資CapitalIQ（XBI指數(shù)價格、IPO融資、并購總交易價值）衰退做好準(zhǔn)備2。2L.E.K.咨詢領(lǐng)袖視角生物制藥行業(yè)展望20243L.E.K.咨詢多行業(yè)玩家對并購交易非常感興趣，希望借此抵消未來因失去市場獨(dú)占權(quán)和《通貨膨脹削減法案》10,11領(lǐng)袖視角生物制藥行業(yè)展望20244L.E.K.咨詢ModernizingandEnsuringPBMAccountabilityAct）13。除了美國，生物制藥企業(yè)還需盡早針對歐洲市場動態(tài)進(jìn)行規(guī)劃14。歐洲衛(wèi)生技術(shù)評估網(wǎng)絡(luò)如InSilicoMedicine的INS018_055在特發(fā)性肺纖維化的二期臨床數(shù)據(jù)15、RelayTherapeutics的領(lǐng)袖視角生物制藥行業(yè)展望2024變革性增量式臨床試驗設(shè)計全渠道互動生產(chǎn)效率質(zhì)量控制人力資源分析具有內(nèi)部數(shù)據(jù)訪問功能的類似ChatGPT的平臺5L.E.K.咨詢領(lǐng)袖視角生物制藥行業(yè)展望20246L.E.K.咨詢領(lǐng)袖視角生物制藥行業(yè)展望20247L.E.K.咨詢28Biopharma、OrnaTherapeutics等公司正在探索的新型體內(nèi)CAR-T細(xì)胞制備方法。30A型血友?。ㄝx瑞和SangamoTherapeutics的基因療法Giroctocogenefitelparvovec預(yù)計將于2024年中期發(fā)布三期臨床數(shù)據(jù)）33和B型血友?。ㄝx瑞和Spark的Fidanacogeneelaparvovec，領(lǐng)袖視角生物制藥行業(yè)展望20248L.E.K.咨詢瘤治療領(lǐng)域，Moderna和默克正在個體化mRNA癌癥疫苗V940與Keytruda聯(lián)合治療高危黑色素是否存在first-in-class和first-in-indication的研發(fā)機(jī)會。最后，放射性藥物和雙特異性抗體這領(lǐng)袖視角生物制藥行業(yè)展望2024公司類別資產(chǎn)適應(yīng)癥臨床一期臨床二期臨床三期申請里程碑百時美施貴寶CD19CART,auto.BreyanziCLLorSLL,R/R(3L+)PDUFA：3月14日強(qiáng)生BCMACART,auto.CarvyktiMultipleMyeloma,R/R,(2L+)PDUFA：3月14日AllovirMVSTcell,allo.PosoleucelAdV;BKV;CMV;EBV;HHV-6;JCV頂線數(shù)據(jù)：第三至四季度ArtivaNKcellwithinnatecellengagerAB-101withAFM13ClassicalHodgkinLymphoma頂線數(shù)據(jù)：第三至四季度AdaptimmuneTCR-TADP-A2M4CD8Ovariancancer,Platinum-resistant頂線數(shù)據(jù)：2024年基因療法公司類別資產(chǎn)適應(yīng)癥臨床一期臨床二期臨床三期申請里程碑OrchardTherapeuticsLVV-transducedCD34+enrichedstemcellsLibmeldy(atidarsageneautotemcel)MetachromaticleukodystrophyPDUFA：3月18日RocketPharmaceuticalsLVV-transducedstemcellsMarnetegrageneautotemcelLAD-IPDUFA：3月31日Vertex/CRISPRTherapeuticsCRISPR-CAS9autologousCD34+Exa-celTransfusion-DependentBetaThalassemiaPDUFA：3月30日輝瑞/SparkTherapeuticsBioengineeredAAVvector(AAV-Spark100)FidanacogeneelaparvovecHemophiliaBPDUFA：第二季度輝瑞AAV6vectorGiroctocogene?telparvovecHemophiliaA頂線數(shù)據(jù)：第二至三季度類別適應(yīng)癥資產(chǎn)臨床一期臨床二期臨床三期里程碑公司類別適應(yīng)癥資產(chǎn)臨床一期臨床二期臨床三期里程碑Oligonucleotide(Telomeraseinhibitor)PDUFA：Oligonucleotide(Telomeraseinhibitor)PDUFA：6月16日ImetelstatGeronCorporationLowerriskmyelodysplasticsyndromeADC(Humanizedanti-HER2IgG1Breastcancer,HER2+(3L+);Others*Breastcancer,HER2+(3L+);Others*mAb+阿斯利康/第一三共Enhertutopoisomeraseinhibitor+tetrapeptidelinker)IonisPharmaceuticals頂線數(shù)據(jù)：第一至二季度DonidalorsenLICA(PKKinhibitor)HAEIonisPharmaceuticals頂線數(shù)據(jù)：第一至二季度DonidalorsenLICA(PKKinhibitor)HAEFamilialARO-APOC3ArrowheadPharmaceuticalsRNAiARO-APOC3ArrowheadPharmaceuticalsRNAi(APOC3Inhibitor)chylomicronemiasyndrome9L.E.K.咨詢領(lǐng)袖視角生物制藥行業(yè)展望20241Asof11/30/2023comparedwithdateofpeakXBIprice(2/8/2021).2L,“CashPreservationintheBiopharmaceuticalIndustry:NavigatingUncertainty.”/insights/hea/us/ei/cash-preservation-biopharmaceutical-industry-navigating-uncertainty3Jefferies,“OctoberBiotechFunding.”4BiopharmaDive,“Lessonsfromabiotechdownturn:Fundingchallenges,anIPOdryspellandwhattoexpectin2024.”https://www./news/biotech-startup-financing-ipo-downturn-lessons/697855/5NewYorkTimes,“KKRBuysMinorityStakeinLifeSciencesInvestorCatalioCapital.”/articles/kkr-buys-minority-stake-in-life-sciences-investor-catalio-capital-e4ee84e6BiopharmaDive,“Afterarecordrun,fewerbiotechsaregoingpublic.Here’showthey’reperforming.”/news/biotech-ipo-performance-tracker/587604/7Biospace,“5LifeSciencesIPOsin2023—andtheFutureForecast.”/article/5-life-sciences-ipo-in-2023-and-the-future-forecast-/8Stifel.9NYTimes,“BidenMakesLowerDrugPricesaCenterpieceofHis2024Campaign.”/2023/08/30/us/politics/biden-medicare-drug-prices-2024-campaign.html?unlocked_article_code=1.7Ew.Ap0i.jTXwQDDVtSrO&smid=url-share10PositionsofotherRepublicanpresidentialcandidatesonrepealingdrugpricingprovisionsoftheInflationReductionActarenotyetfullyclear.11AssociatedPress,“Trumpmakeslate-termbidtolowerprescriptiondrugcosts.”/article/donald-trump-medication-prescription-drug-costs-medicare-prescription-drugs-e171198402445755b920842ded293b5912C,“HR5378.”/bill/118th-congress/house-bill/5378/text#toc-H3EB5C78AAFDE4912BE147826E4A93E9F13C,“ModernizingandEnsuringPBMAccountabilityAct.”/imo/media/doc/092823_mepa_legislative_text.pdf14L,“EUnetHTA21—TransitiontoEU-wideHTAs:ImplicationsforPharma.”/insights/hea/eu/ei/eunethta-21-transition-eu-wide-htas-implications-pharma