領袖視角1領袖視角生物制藥行業展望2024領袖視角2L.E.K.咨詢7920192020202120222023**173020192020202120222023** 5420192020202120222023**7920192020202120222023**173020192020202120222023** 5420192020202120222023**XBI指數價格*250200148 100 1001188710087500IPO融資^ 100218 185 185150100500風險投資250203200150155150風險投資25020320015015515010050020192020202120222023**總并購交易價值250200150100100566030505660300*2023年之前的XBI指數價格截至年底**2023年風險投資價值于2023年12月15日更新（來自Pitchbook其他指標則于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=風險投資；XBI=SPDR標普生物科技；美國IPO和并購交易包括CapitalIQ中從行業分類中選擇的已宣布和已完成的交易，這些行業分類包括制藥、生物技術和生命科學、生物技術、制藥、醫藥產品、藥品研究與開發；PitchBook數據未經PitchBook分析師審核資料來源：PitchBook（風險投資CapitalIQ（XBI指數價格、IPO融資、并購總交易價值）衰退做好準備2。領袖視角生物制藥行業展望2024領袖視角3L.E.K.咨詢多行業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占權和《通貨膨脹削減法案》10,11領袖視角生物制藥行業展望2024領袖視角4L.E.K.咨詢ModernizingandEnsuringPBMAccountabilityAct）13。.除了美國，生物制藥企業還需盡早針對歐洲市場動態進行規劃14。歐洲衛生技術評估網絡如InSilicoMedicine的INS018_055在特發性肺纖維化的二期臨床數據15、RelayTherapeutics的領袖視角生物制藥行業展望2024領袖視角5L.E.K.咨詢變革性篩選驗證增量式臨床試驗設計全渠道互動人力資源分析具有內部數據訪問功能的類似ChatGPT的平臺領袖視角生物制藥行業展望2024領袖視角6L.E.K.咨詢領袖視角生物制藥行業展望2024領袖視角7L.E.K.咨詢28Biopharma、OrnaTherapeutics等公司正在探索的新型體內CAR-T細胞制備方法。30A型血友病（輝瑞和SangamoTherapeutics的基因療法Giroctocogenefitelparvovec預計將于2024年中期發布三期臨床數據）33和B型血友病（輝瑞和Spark的Fidanacogeneelaparvovec，領袖視角生物制藥行業展望2024領袖視角8L.E.K.咨詢瘤治療領域，Moderna和默克正在個體化mRNA癌癥疫苗V940與Keytruda聯合治療高危黑色素是否存在first-in-class和first-in-indication的研發機會。最后，放射性藥物和雙特異性抗體這9L.E.K.咨詢公司類別適應癥資產里程碑CLLorSLL,R/R(3L+)PDUFA：3月14日PDUFA：3月14日百時美施貴寶強生CD19CART,auto.BreyanziMultipleMyeloma,R/R,(2L+)CarvyktiBCMACART,auto.AdV;BKV;CMV;EBV;HHV-6;JCV頂線數據：第三至四季度AllovirMVSTcell,allo.PosoleucelClassicalHodgkinLymphomaAB-101withAFM13NKcellwithinnatecellengager頂線數據：第三至四季度ArtivaOvariancancer,Platinum-resistantADP-A2M4CD8AdaptimmuneTCR-T公司適應癥里程碑資產類別MetachromaticleukodystrophyLVV-transducedCD34+enrichedstemcellsLibmeldy(atidarsageneautotemcel)OrchardTherapeuticsPDUFA：3月18日RocketPharmaceuticalsLVV-transducedstemcellsMarnetegrageneautotemcelPDUFA：3月31日LAD-I公司類別適應癥資產里程碑CLLorSLL,R/R(3L+)PDUFA：3月14日PDUFA：3月14日百時美施貴寶強生CD19CART,auto.BreyanziMultipleMyeloma,R/R,(2L+)CarvyktiBCMACART,auto.AdV;BKV;CMV;EBV;HHV-6;JCV頂線數據：第三至四季度AllovirMVSTcell,allo.PosoleucelClassicalHodgkinLymphomaAB-101withAFM13NKcellwithinnatecellengager頂線數據：第三至四季度ArtivaOvariancancer,Platinum-resistantADP-A2M4CD8AdaptimmuneTCR-T公司適應癥里程碑資產類別MetachromaticleukodystrophyLVV-transducedCD34+enrichedstemcellsLibmeldy(atidarsageneautotemcel)OrchardTherapeuticsPDUFA：3月18日RocketPharmaceuticalsLVV-transducedstemcellsMarnetegrageneautotemcelPDUFA：3月31日LAD-ITransfusion-DependentBetaThalassemiaVertex/CRISPRTherapeuticsCRISPR-CAS9autologousCD34+PDUFA：3月30日Exa-celBioengineeredAAVvector(AAV-Spark100)輝瑞/SparkTherapeuticsFidanacogeneelaparvovecPDUFA：第二季度HemophiliaBHemophiliaAGiroctocogene?telparvovec輝瑞頂線數據：第二至三季度AAV6vectorOligonucleotide(Telomeraseinhibitor)PDUFA：6月16日ImetelstatGeronCorporationIonisPharmaceuticals頂線數據：第一至二季度LICA(PKKinhibitor)Donidalorsen領袖視角生物制藥行業展望2024細胞療法臨床一期臨床二期臨床三期基因療法臨床一期臨床二期臨床三期公司資產類別適應癥臨床一期臨床二期里程碑臨床三期公司資產類別適應癥臨床一期臨床二期里程碑LowerLowerriskmyelodysplasticsyndromeADC(Humanizedanti-HER2IgG1Breastcancer,HER2+(3L+);Breastcancer,HER2+(3L+);Others*PDUFA：第三至四季度阿斯利康/第一三共Enhertutopoisomeraseinhibitor+tetrapeptidelinker)HAEHAEFamilialARO-APOC3ArrowheadPharmaceuticals頂線數據：第一至二季度chylomicronemiaARO-APOC3ArrowheadPharmaceuticals頂線數據：第一至二季度chylomicronemiasyndromeInhibitor)領袖視角生物制藥行業展望2024領袖視角10L.E.K.咨詢1Asof11/30/2023comparedwithdateofpeakXBIprice(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#:~:text=The%20EU%20HTA%20regulation%20formulated,key%20for%20a%20successful%20JCA.15CNBC,“ThefirstfullyA.I.-generateddrugentersclinicaltrialsinhumanpatients.”/2023/06/2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