科济药业-B二零二五年中期报告

2345284647484950626366 183171712-1716 46621 33191918 02171 97927 P.O. Box 31119Grand PavilionHibiscus Way802 West Bay RoadGrand Cayman KY1-1205Cayman Islands www.carsgen.com Maples Fund Services (Cayman) LimitedP.O. Box 1093, Boundary HallCricket Square, Grand Cayman KY1-1102Cayman Islands 717710 3A10 46 1. 202563051賽愷澤®BCMACAR-TCAR-T 2. 202563029 3. 2025630752024630352277(i)202463054112202563058(ii)20246302461162025630130(iii)20246308647202563039(iv)20256302920246301.6 2025630(1)722024630342270(i)(ii)(iii)(iv)(v) 4. 20256301,261202412311,47921820251,1002028 (1) 賽愷澤®CT053 B(BCMA)CAR-T(NMPA)(R/RMM)3000963.SZ賽愷澤®賽愷澤®2025賽愷澤®20111賽愷澤® CT041 Claudin18.2(CLDN18.2)CAR-T20256NMPA(CDE)(NDA)Claudin18.2(G/GEJA)20255CDE20253(BTD)II(NCT04581473)The Lancet2025(ASCO) CAR-T T H A N K - u C A R®C A R - TT H A N K - uPlus™THANK-uCAR®NKG2ACAR-TTHANK-u Plus™R/R MM(R/R PCL)BCMACAR-TCT059620255 CAR-TBCMAR/R MMR/R PCLCT0596(THANK-u PlusTM)CD19/CD20BKJ-C2219(THANK-uPlus™)CD38(AML)KJ-C2320THANK-uCAR®KJ-C2114(THANK-uPlus™)NKG2DLKJ-C2526 (THANK-u Plus™) I. CAR-TCAR-TCAR-T II. CAR-TCAR-T 2025NMPANDAClaudin18.2G/GEJANDACAR-T賽愷澤®THANK-uCAR®CAR-TTHANK-uPlus™CAR-TCAR-T 1. 2.II HK Inno.N Corporation195940 賽愷澤®CT053BCMA CAR-T R/RMMBCMACAR-TBCMA(scFv)CARCAR-TT 賽愷澤®2024223NMPAR/RMM320231賽愷澤®200751,025賽愷澤®賽愷澤®2025賽愷澤®20111賽愷澤® 賽愷澤® LUMMICAR-1202461529(EHA)BCMACAR-T2Phase 2 study of fully human BCMA-targeting CAR-T cells (zevorcabtagene autoleucel) in patientswithrelapsed/refractory multiple myeloma102賽愷澤®ORR92.2%(94/102)VGPR91.2%(93/102)(sCR/CR)71.6%(73/102) LUMMICAR-2 18A.08(3) Claudin18.2 CAR-T Claudin18.2CAR-TClaudin18.2G/GEJAPCClaudin18.2G/GEJAPCCAR-TClaudin18.2CAR-TCAR-T 2025625NMPACDENDAClaudin18.2G/GEJANDAII(CT041-ST-01,NCT04581473)202553CDE II(CT041-ST-01,NCT04581473)The Lancet2025ASCOTheLancetClaudin18.2CAR-T(CT041-ST-01)IIClaudin-18isoform 2-specific CAR T-cell therapy(satri-cel)versus treatmentofphysician’s choice for previously treated advanced gastric or gastro-oesophageal junction cancer(CT041-ST-01): a randomised, open-label, phase 2 trial2025ASCOClaudin18.2CAR-TII(CT041-ST-01)Claudin18.2-specific CAR Tcells (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 PCI(CT041-ST-05,NCT05911217)G/GEJA(CT041-CG4010, NCT06857786) CT041-CG4006202463NatureMedicineClaudin18.2CAR-TIClaudin18.2-specific CART cells in gastrointestinal cancers: Phase 1 trial final results202462024ASCO(mPFS)mOS15.295%CI6.816.495%CI7.012OS60.0%95% CI12.6, 88.2 20245CT041Safety and Efficacy of CT041 in Patients With Refractory Metastatic Pancreatic Cancer: A PooledAnalysis of Two Early-Phase TrialsJournal of Clinical OncologyI/Ib(CT041-CG4006CT041-ST-01) 20242Claudin18.2-CARTMetastaticgastriccancertarget lesion complete response with Claudin18.2-CAR T cellsJournal forImmunoTherapyof Cancer28 20239NCT04581473NCT03874897Journal of Hematology & OncologyCT041 CAR-TClaudin18.2CT041 CAR T cell therapy for Claudin18.2-positive metastaticpancreatic cancer 18A.08(3) CT011GPC3 CAR-T CT011CAR-T(HCC)GPC3CAR-THCC 20237CAR-GPC3 TCombined local therapy and CAR-GPC3 T-cell therapy in advanced hepatocellular carcinoma: a proof-of-concepttreatment strategyCancer CommunicationGPC3 CAR-THCC7 20241CT011NMPAINDGPC3IIIa 18A.08(3)CT011 CT071 – GPRC5D CAR-T CT071CARcelerate®GPRC5DCAR-TR/RMMR/R pPCL(scFv) CARcelerate®CT07130CAR-T CT071(NDMM)(NCT06407947)30EHAGPRC5DCAR-TCT071IA phase I study of GPRC5D targeting CAR T-cell therapy CT071 for high-risk newlydiagnosedmultiple myeloma(ORR)100%70%(7/10)(sCR) CT071R/RMMRR/PCLIIT(NCT05838131)20241266ASHGPRC5DCAR-TCT071GPRC5D-Targeted CAR T-Cell Therapy CT071 for the Treatment of Refractory/Relapsed MultipleMyeloma 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 Myeloma CT0596THANK-uPlus™BCMACAR-TCT0596R/RMMR/RPCL2025568R/R MMFC22.5-30mg/m2350-500mg/m243(60%)sCR/CR4(80%)(MRD)sCR/CR4(DLT)3(CRS)(ICANS)(GvHD)CT0596R/RMMCAR-T KJ-C2219THANK-uPlus™CD19/CD20CAR-T2024B(R/RB-NHL)2025(SLE)(SSc)KJ-C2219R/RB-NHLSLESSc KJ-C2320THANK-uCAR®CD38CAR-T2024KJ-C2320 KJ-C2114THANK-uPlus™CAR-T KJ-C2526THANK-uPlus™NKG2DLCAR-T 202522580,000,0008%100%92% CAR-TBCMACAR-TBCD19/CD20CAR-TCAR-T CAR-T CAR-TCAR-T CAR-T (1)CAR-T CAR-TTHANK-uCAR®THANK-uCAR®TCAR-TT(GvHD)(HvGR)TRACβ2(B2M)TCRI(HLA-I)(NK)HLA-ITCAR-TCAR-TNKNKG2ACARTRAC-B2M-TNKG2ANKCAR-TTHANK-uCAR-TNKNKG2ACARTRAC-B2M TNKNKNKG2ANKG2ATHANK-u PlusTMTHANK-u Plus™THANK-uCAR®CAR-TN K G2AN KT H A N K - uPlus™THANK-