创胜集团-B2023年年度报告

2023 245612366772929798100101103176178 20238 23Kumar Srinivasan20238 23 •88135 Walkers Corporate Limited190 Elgin Avenue, George TownGrand Cayman KY1-9008Cayman Islands Kumar Srinivasan 218B6-501215123 Kumar Srinivasan 3485 Skadden, Arps, Slate, Meagher & Flom1542 1617 86/10/11/16/17 110 158 Walkers (Hong Kong)1815 6628 http://www.transcenta.com/ 8240 Walkers Corporate Limited190 Elgin Avenue, George TownGrand Cayman, KY1-9008Cayman Islands 20232023osemitamab (TST001)blosozumab (TST002) 2023Claudin18.2osemitamab (TST001)IIIIIFDAMFDSosemitamab (TST001)100 2023blosozumab (TST002)I(BMD)blosozumab (TST002)II IIIosemitamab (TST001)CDMO osemitamab (TST001)blosozumab(TST002)II 20243 27 •202212 31101.9202312 3153.8CDMO•202212 3146.49.1202312 3137.3202312 31•202212 3129.727.3202312312.4•202212 31349.832.2202312 31382.0•202212 31112.45.020231231117.4•202212 31417.748.0202312 31465.7 •202212 31101.9202312 3153.8CDMO •202212 3146.49.1202312 3137.3202312 31•202212 31340.532.0202312 31372.5•202212 31104.96.3202312 3198.6•202212 31400.936.4202312 31437.3 2023 Claudin18.2osemitamab (TST001)II(FDA)(CDE)(MFDS)III2024(EMA)(PMDA)IIIosemitamab (TST001)Claudin18.2(G/GEJ)osemitamab (TST001)Claudin18.2osemitamab (TST001) blosozumab (TST002)I(BMD)CDEII GREMLIN-1TST003I HiCBosemitamab (TST001)GMP OsemitamabTST001ADCCClaudin18.2 •202312023(ASCO)(GI2023)osemitamab (TST001)(CAPOX)(G/GEJ)I/II(TranStar102)•20233Claudin18.2PET[89Zr]Zr-DFO-TST001•20233FDAosemitamab (TST001)•20234I/IITranStar102NCT04495296Cosemitamab (TST001)CAPOXGosemitamabCAPOXClaudin18.2(G/GEJ)Transtar101CGIII(TranStar301)•20234MFDSIII(TranStar301)20237•20236(ASCO)osemitamab (TST001)CAPOX(G/GEJ)TranStar102C(PFS)9.5(DoR)9.9TranStar101TranStar101I/IIaosemitamab (TST001)osemitamab (TST001)mFOLFOX6(G/GEJ)•20236(ESMO GI)TranStar102 CClaudin18.2PFSosemitamab (TST001)CAPOXClaudin18.2(G/GEJ)(G/GEJ)55%III(TranStar301)•20237MFDSosemitamab (TST001)Claudin18.2TranStar301III •20239FDAEOP2IIIFDAosemitamab (TST001)Claudin18.2(G/GEJ)TranStar301IIIosemitamab (TST001)Claudin18.2(G/GEJ)Claudin18.2osemitamab (TST001) •2023102023ESMOosemitamab (TST001)CAPOX(G/GEJ)TranStar102CC6mg/kg Q3W(ORR)55%(DoR)12.7(PFS)14.0PD-L1PD-L1osemitamab (TST001)PD1/PD-L1osemitamab (TST001)PD1/PD-L1III •202312[177Lu]Lu-TST001(EJNMMI) OSEMITAMAB (TST001)CDX •GMPClaudin18.2 CDxGMPIII(TranStar301) BlosozumabTST002 •20231blosozumab (TST002)(SAD)(NCT05391776)32•20233blosozumab (TST002)IIIND •20235blosozumab (TST002)I(NCT05391776)(CSOBMR) 202332blosozumab (TST002)851200 mgblosozumab (TST002)85BMD3.52%6.20%BMD1.30%2.24%BMD(2.77%)BMDBMDblosozumab (TST002)II •20237II TST003GREMLIN-1 •20231TST003IND•20233TST003(FIH)(NCT05731271)•20234(AACR)2023TST003TST003(MSS CRC)(CRPC)•202310•202311TST003 TST005PD-L1/TGF-β •20236(ASCO)TST005PD-1PK/PDTGFβ-1PD-L1 TST010T •20234(AACR)2023TST010TST010TMEPD-1/PD-L1 TST012ADC •TST012ADCosemitamab (TST001) TST013ADC •TST013ADCADCTOPI TST801 •TST801B(SLE)IND OsemitamabTST001ADCCClaudin18.2 •BMSTranStar102osemitamab (TST001)82TranStar10118•(CDx)Claudin18.2CDx• CMCCDMO CMC •osemitamab (TST001)MCC(Merck KGaA)Combo(PPQ)GMP•blosozumab (TST002)10•IND •HiCBHiCB•MCCComboGMP•ADC•ExcelPro CDMO •2023CDMOCHOsiRNA DPADCCMC osemitamab (TST001)Claudin18.2IIIFDA(MFDS)Claudin18.2 CMCHiCBCMCCDMO 13 PD-L1=1VEGFR2=2TGFβ=βMASP2=2IND=FIC=HPV=BMP=TACI=CAMLCAML=NSCLC=SLE=TMA=IgA=ACombo=Chemo=VEGFR2=2 (1) (2) 2023 osemitamab (TST001)MSB0254TST003 TST005 TST006 TST010 TST012 TST013 •Osemitamab (TST001)Claudin18.2III(TranStar301)osemitamab (TST001)Claudin18.2FDA(MFDS)2023Claudin18.2 •MSB0254VEGFR2MSB0254IRP2D•TST003GREMLIN-1(FIH)•TST005PD-1/PD-L1TGF-βPD-1/PD-L1TST005I2023•TST006Claudin18.2-PD-L1•TST010TT•TST012ADC•TST013HR+HER2-ADC TST005MSB0254TST003 TST010osemitamab (TST001)osemitamab (TST001)Claudin18.2TST003MSB0254 Osemitamab (TST001)ADCCClaudin18.2 Osemitamab (TST001)Claudin18.2ADCCClaudin18.2osemitamab (TST001)Claudin18.2 IIIClaudin18.2zolbetuximabClaudin18.2Claudin18.2Zolbetuximab38%osemitamab (TST001)Claudin18.2zolbetuximabADCCClaudin18.2osemitamab (TST001)55%osemitamab (TST001)Claudin18.2 2023IIFDAMFDSIII(TranStar301)osemitamab (TST001)Claudin18.22024EMAPMDA 2023osemitamab (TST001) •202312023(ASCO)(GI 2023)osemitamab (TST001)CAPOX(G/GEJ)I/II(TranStar102)•20233Claudin18.2PET[89Zr]Zr-DFO-TST001•20233FDAosemitamab (TST001)•20234I/IITranStar102NCT04495296Cosemitamab (TST001)CAPOXGosemitamab (TST001)CAPOXClaudin18.2(G/GEJ)TranStar101CGIII(TranStar301)•20234MFDSIII(TranStar301)20237 •20236(ASCO)osemitamab (TST001)CAPOX(G/GEJ)TranStar102C(PFS)9.5(DoR)9.9TranStar101TranStar101I/IIaosemitamab (TST001)osemitamab (TST001)mFOLFOX6(G/GEJ) •20236(ESMO GI)TranStar102 CClaudin18.2PFSosemitamab (TST001)CAPOXClaudin18.2(G/GEJ)(G/GEJ)55%III(TranStar301) •20237MFDSosemitamab (TST001)Claudin18.2TranStar301III •20239FDAEOP2IIIosemitamab (TST001)Claudin18.2(G/GEJ)TranStar301IIIosemitamab (TST001)Claudin18.2(G/GEJ)Claudin18.2Osemitamab(TST001) •202310202