科济药业-B二零二五年年度报告

Maples Fund Services (Cayman) LimitedP.O. Box 1093, Boundary HallCricket SquareGrand Cayman KY1-1102Cayman Islands 3A10 46621 33191918 P.O. Box 31119Grand PavilionHibiscus Way802 West Bay RoadGrand Cayman KY1-1205Cayman Islands 183171712-1716 02171 97927 www.carsgen.com 717710 46 2025 2025賽愷澤®2024312154賽愷澤®20252025218125.7 Claudin18.2CAR-T（：愷力美TM）(NDA)CAR-T20256(NMPA)(CDE)2026CAR-T 2025CAR-T 2 0 2 5THANK-uCAR®THANK-uPlusTMCAR-TCT0596BCMACT1190BCD19/CD20CAR-TCT0596(R/RMM)(pPCL)(IND)2026IbCT1190B(KJ-C2219)2026INDIbCAR-TIITCD38KJ-C2320NKG2DLKJ-C2526 CAR-TCARvivo™CD19/CD20CAR-T 2025 1. 2 0 2 51 23 11 2 5 . 7賽 愷 澤®B C M ACAR-T賽愷澤®CAR-T 2. 2025123180 3. 2025123110320241231798695(i)2024123126037720251231117(ii)2024123146622120251231245(iii)20241231160922025123168(iv)20251231802024123115 20251231(1)7820241231789711(i)(ii)(iii)(iv) 4. 202512311,123202412311,47935620261,0002030 (1) 賽愷澤®CT053 賽愷澤®B(BCMA)CAR-T(NMPA)R/RMM3000963.SZ賽愷澤®賽愷澤®2025218賽愷澤®賽愷澤®2025R/RMM賽愷澤®I202510Blood Advances 愷力美TMCT041 Claudin18.2(CLDN18.2)CAR-T20253NMPACDE(BTD)2025520256CDENDAClaudin18.2( G / G E J A )2026II(NCT04581473)20256TheLancet2025(ASCO)IbCT041-ST-05NCT059112172025(ESMO) CAR-T THANK-uCAR®THANK-u PlusTMCAR-TTHANK-uPlus™THANK-uCAR®NKG2ACAR-T20251011CT0596THANK-uPlusTMBCMACAR-T(R/R pPCL)CT1190BTHANK-u PlusTMCD19/CD20CAR-TB(R/RB-NHL)CT0596IITR/R MM20251267(ASH) CAR-TCT0596R/RMMpPCLIND2026INDIbCT1190B(KJ-C2219)2026INDIbCAR-TCD38(AML)KJ-C2320THANK-uCAR®NKG2DLAMLKJ-C2526(THANK-u Plus™)CLL1AMLCT1390B (THANK-u PlusTM)Claudin18.2(GC)KJ-C2527 (THANK-u PlusTM) I. CAR-TCAR-TCAR-T II. CAR-TCAR-T 2025NMPANDAClaudin18.2G/GEJANDACAR-T賽愷澤® CAR-TCAR-TTHANK-uCAR®THANK-uPlus™CAR-TCT05962026INDIbCT1190B2026INDIbCD38AMLKJ-C2320NKG2DLAMLKJ-C2526CLL1AMLCT1390BClaudin18.2GCKJ-C2527 1. 2.II3.000963 賽愷澤®CT053BCMA CAR-T 賽愷澤®R/RMMBCMACAR-TBCMA(scFv)CARCAR-TT NMPA202431賽愷澤®2024223R/RMM3賽愷澤®2025R/RMM20231賽愷澤®200751,025賽愷澤®賽愷澤®2025賽愷澤®20218 賽愷澤® 賽愷澤®I2025922I M S202510BloodAdvancesZevor-celLongterm Follow-up of Zevor-cel in Patients with Relapsed/Refractory MultipleMyeloma 1 0 22 0I I2 0 2 59E x p e r i m e n t a lHematology&OncologyBCMACAR-TIIPhase II study of zevorcabtagene autoleucel, a fully humanBCMA-targeting CAR T cell therapy, in patients with relapsed/refractory multiple myeloma 18A.08(3) 愷力美TMCT041Claudin18.2 CAR-T Claudin18.2CAR-TClaudin18.2G/GEJAPCClaudin18.2G/GEJAPCCAR-TClaudin18.2CAR-TCAR-T 20253CDEBTD202552025625CDENDAClaudin18.2G/GEJANDAII(CT041-ST-01, NCT04581473)2026Claudin18.2(IHC)NMPAClaudin18.2 PCIbCT041-ST-05NCT05911217202510ESMOClaudin18.2CAR T(Satri-cel)(CT041-ST-05)Adjuvant Therapy with Claudin18.2-specific CART Cells (Satri-cel) in High-Risk Pancreatic Cancer (CT041-ST-05)CAR-T(POC)152 PCI(CT041-ST-05,NCT05911217)G/GEJA(CT041-CG4010, NCT06857786)G/GEJA(CT041-CG4011, NCT07179484) II(CT041-ST-01,NCT04581473)The Lancet202562025ASCOThe LancetClaudin18.2CAR-T(CT041-ST-01)IIClaudin-18isoform 2-specific CAR T-cell therapy(satri-cel)versustreatment of physician’s choice for previously treated advanced gastric or gastro-oesophageal junctioncancer (CT041-ST-01): a randomised, open-label, phase 2 trial2025ASCOClaudin18.2CAR-TII(CT041-ST-01)Claudin18.2-specific CART cells (Satri-cel) versus treatment of physician’s choice (TPC) for previously treated advanced gastric orgastroesophageal junction cancer (G/GEJC): Primary results from a randomized, open-label, phase II trial(CT041-ST-01)1088820(TPC)(mOS)9.1728TPCmOS3.98(HR 0.288; 95% CI: 0.169-0.492)Claudin18.2G/GEJA(PFS)OSCAR-T(RCT)CAR-TRCTCAR-TCAR-TCAR-TCAR-T 18A.08(3) CT011GPC3 CAR-T CT011CAR-T(HCC)GPC3CAR-THCC 20237C A R - G P C3 TCombined local therapy and CAR-GPC3 T-cell therapy in advanced hepatocellular carcinoma: aproof-of-concepttreatment strategyCancer CommunicationGPC3 CAR-THCC10 20241CT011NMPAINDGPC3IIIa 18A.08(3)CT011 CT071 – GPRC5D CAR T CT071CARcelerate®GPRC5DCAR-TR/R MMR/R pPCL(scFv) CARcelerate®CT07130CAR-T R/R MM(NCT05838131)202510The LancetHaematologyGPRC5DCAR-T(CT071)IGPRC5D-targeted CAR T-cell therapy (CT071) in patientswithrelapsed or refractory multiple myeloma:a first-in-human,single-centre,single-arm,phase 1trial5BCMA CAR-T (n=1)BCMA/CD19 CAR-T (n=4)2PR1VGPR2sCR (NDMM)(NCT06407947)2025630EHA)GPRC5DCAR-TCT071IA phase I study of GPRC5D targeting CAR T-cell therapyCT071 for high-risk newly diagnosed multiple myelomaORR100%70% (7/10)sCR 18A.08(3)CT071 CAR-T THANK-uCAR®CAR-TTHANK-u Plus™THANK-uCAR®CAR-TNKG2A CT0590THANK-uCAR®BCMACAR-TCT0590R/R MMCT0590 IIT20241266ASHCT0590BCMANKG2ACAR-TA First-in-HumanStudy of CT0590, a Triple Knock-out, Allogeneic CAR T-Cell Therapy Targeting BCMA and NKG2A, inSubjects with Relapsed/Refractory Multiple Myeloma2sCR1R/RMMDOR23sCR1pPCLDOR202sCRCAR280,000 copies/μgDNA(gDNA) CT0596THANK-uPlus™BCMACAR-TCT0596R/RMMPCLR/RMMpPCL202512NMPAIND2026IbIIT20251267ASH20258318R/RMMCT05966PR3CR/sCR1VGPR2PRCAR-T018sCRMRDCT0596R/RpPCL202510172pPCLCT0596sCR CT1190B(KJ-C2219)THANK-uPlus™CD19/CD20CAR-