映恩生物-B2025 年度报告

年 度 報 告 21213161920326091118127128130131132 2019ADC DB-1303/BNT323HER2 ADCECBCDB-1311/BNT324B7-H3 ADCPCSCLCNSCLCOCCCESCCHNSCC(i)ADC(ii)ADC2026 20263232026323 20263232026323 Harneys Fiduciary (Cayman) Limited 4th Floor, Harbour Place103 South Church StreetGeorge TownP.O. Box 10240Grand Cayman KY1-1002Cayman Islands 99B3301 868A11 24840 1526 22 4th Floor, Harbour Place103 South Church StreetGeorge TownP.O. Box 10240Grand Cayman KY1-1002Cayman Islands 1 375 183171712-1716 2025ADC 3,200IO 2.0+ADCBioNTechADCPD-L1/VEGF DB-1303/BNT323HER2III HER3 ADC DB-1310FDAEGFR/HER3ADC DB-1418AvenzoIBDCA2 ADC DB-2304ADAM9 ADC DB-131710 ASCOAACR ESMO MSCI (Global Biopharma)ConnectExcellence Ownership C.E.OADC=CP² 20264 26 (1)202541520232024202512 311,017.9873.42,206.1 (2) 552024812 20(2616. HK)(9995.HK)(603087.SH)(300676.SH)201820196 Dimensions Capital20152017Wuxi Healthcare Ventures20082015Mingxin CapitalSIG Asia Investment Fund GreenwoodsInvestmentHighLight Capital 2013920147(1515.HK)2016420188(2616.HK)2006GNI Group Ltd 199272001620051220207 4020214 2320248 12202052021720218202422021420263 18200892015112015122017620172201912600119 20087202211MBAFMBA201512 4620217202432026323 152009201412014120182Eli LillyLLY20182202163692 200372009720197 4420247 2220248 12 1420231201242016720173202212 2004720095 4020214 2320248 12 2025220183202522015720182 2008720155 452025415 19(i)2021120226202510IPHERE(ii)202153983(iii)2025 102651 200610200710201042010920101020148201492018122019120203 2003620066(CICPA)CIA(CTA) 562025415 1990(i)20077(ii)20129(iii)20221000958 •20161300614 •201811CNFinance Holdings LimitedCNF•201912600682•201510201711600984•2016820235002116•201722020400207120215 1992720021 4920254 15 200712008520085200812200932010420111220203 199872001620035200412 13.51(2) 55 46 4620201020214 2320248 1220263 23 24200212002119987YUMC 20064 •20091201111Novartis AGNVSNOVN •20111220131120148201812Tecan Group AGTECN •20131120148DOW •2018122020102196600196 20016202311 532021720223Duality U.S. 2020043201512GlaxoSmithKline plc.GSKGSK2016420195JNJ2019520217Daiichi Sankyo Inc.4568ADC 199412199712 (i)2006520084Biogen IdecBIIB(ii)2008520104Genentech, Inc.(iii)2010520141HCM(iv)20142201672359603259(v)2016820201 2096(vi)2020 220214Hillhouse Bioventure(vii)202012Overland Pharmaceuticals(viii)2021 4202312Zenas BioPharma Inc.ZBIO 1985419877199512 5420253 199710200112Schering-Plough Research Institute2020031Thomas Weisel Partners LLC20045UBS Securities LLC2007320219 1994719961120031202392023 432021820229 212004820069(i)2006 10200712(ii)20097201611(iii)20171220217 44 142012220181Bristol-Myers SquibbCompanyE.R. Squibb & Sons LLC2018120202Genentech Inc.Roche Holding AGDaiichi Sankyo Inc. 20046200612201152011520121FDA 55 2020078201112Eisai Co., Ltd.45232012120185201852020101801202011202311I-MabIMAB 2001720207 20254 15 17202292023720171120228656219660019620114201752009820112 2009620176 202481210 13.51B(1) 2026323 13.51B(1) 2019ADC ADCADCADCADCADC13ADC DB-1303/BNT323ECBCHER2 ADCDB-1311/BNT324PCSCLC NSCLC OC CCESCCHNSCCB7-H3 ADC(i)ADC(ii)ADC2026 (DB-1303/BNT323) (DB-1303/BNT323)HER2 ADC1/2HER2HER2 FDAECECBCOC CRC BioNTech BC •3DYNASTY-Breast02; NCT06018337HR+HER2PFS20262 BioNTech2026 •T-DM13(NCT06265428)HER2+BC 202595IDMC3T-DM1BICRPFS 20264(BLA)(CDE) •1/2(NCT06827236)pumitamig(PD-L1xVEGF bsAb)HR+HR-HER220255BioNTech2026 •1/2a(NCT05150691)HER2 202642026SGOBioNTech2HER21/2aHER2IHCIHC3+2+1+ BioNTech2026BLAFDA •BioNTech3(NCT06340568)HER2480PFSORR (DB-1303/BNT323) DB-1311/BNT324 DB-1311/BNT324B7-H3 ADCB7-H3B7B7-H3PCSCLCNSCLCOC CCESCCHNSCCDB-1311/BNT324B7-H3DB-1311/BNT324B7-H3Fc 2024FDADB-1311/BNT324CRPCESCCSCLCBioNTechDB-1311/BNT324 PC •1/2(NCT05914116)DB-1311/BNT324 20256ASCO20253 473mCRPCDB-1311/BNT324uORR42.3%cORR 30.8%DCR90.4%(n=52)6rPFS67.7%(n=68)CRPCn=73DB-1311/BNT324≥3TRAE42.5% 20262ASCO20251229146mCRPC4DB-1311rPFS11.3OS22.5-177rPFS13.6 52-177587%40%rPFS11.3OSn=45 1-26 mg/kg11022(20.0%)3TRAETRAE6(5.5%) 3(NCT07365995)2026DB-1311/BNT324mCRPCPFSOS •1/2(NCT05914116)PCDB-1311/BNT324SCLCNSCLC HNSCC HCC OC CC2024ESMO 202512ESMOPROC20259 5DB-1311/BNT324(n=30)uORR43.3%cORR 33.3%DCR 86.7%mPFS 7.0PROC(n=12)cORR 58.3%DCR75.0%mPFS8.21-2(4.7%) 202642026SGO20251229DB-1311/BNT324(n=33)uORR 42.4%DCR81.8%mPFS 7.0PROC(n=30)uORR 53.3%DCR 83.3%mPFS 9.574(2.7%)(ILD)DB-1311/BNT324 •BioNTechDB-1311/BNT324 1/2(NCT06892548)DB-1311/BNT324pumitamig20255BioNTech2026 2(NCT06953089)DB-1311/BNT324pumitamigTROP2ADCDB-1305/BNT32520257BioNTech2026 1(NCT05142189)DB-1311/BNT324BNT116mRNANSCLC20255 DB-1311/BNT324 DB-1310 DB-1310HER3 ADCHER3EGFR HER2HER3EGFR/HER2DB-1310HER3 HER3 ADC NSCLC •1/2(NCT05785741)DB-1310 20256ASCO20254 111.5mg/kg6.5mg/kg(n=172)DB-1310≥3TRAE36%3.5%46DB-1310EGFRm NSCLCuORR43.5%cORR28.3%DCR 91.3%PFS7.03OS18.895 mg/kg (n=16)cORR37.5%DCR 87.5%mPFS8.28mOS •DB-1310EGFRm NSCLCEGFRm NSCLC •20257DB-1310FDANSCLCEGFR19L858REGFR(TKI) BC •1/2(NCT05785741)DB-13