科济药业-B二零二四年中期报告

2356294546474849626366 ʮ̡༟ࣘ 20244292024429 183171712-1716 46621 3485 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 ࠅุਕ࿜ 賽愷澤®CT053 賽愷澤®B(BCMA)CAR-T202431(NMPA)賽愷澤®2024223(R/RMM)3000963.SZ賽愷澤®賽愷澤®2024731賽愷澤®201910052賽愷澤®II29(EHA)賽愷澤® (CT041) Claudin18.2(CLDN18.2)CAR-T(GC/GEJ)II(NCT04581473)(CT041-CG4006,NCT03874897)20246Nature Medicine2024ASCO(PC)CT041-CG4006CT041-ST-01Journal of ClinicalOncology RTPCMC(CT041-ST-02,NCT04404595)FDA M R N AClaudin18.2 mRNA CT011 CT011Glypican-3(GPC3)CAR-TCT01120241NMPAINDGPC3IIIa CT071 CT071GC5D(GPRC5D)CAR-TCT071CARcelerate®MM(pPCL)CARcelerate®30CAR-TR/RMM(R/RPCL)(NCT05838131)2024629EHA(NCT06407947)(NDMM)RTPCMC(CT071-HM-001, NCT06333509)FDA CAR-T THANK-uCAR®CAR-TCT0590R/R MMPCLKJ-C2320KJ-C2219CD19CD20BCAR-TKJ-C2114 CAR-TCAR-T GMPCAR-T(RTP)GMPRTPCAR-TRTP700CAR-T 202312FDARTPCAR-T483CT071483202312FDA(CAPAs)202434520245FDAFDA202467CAPAsFDACAPAsFDAFDACGMPFDA ࠅৌਕ࿜ 1. 20246306賽愷澤®BCMA CAR-T賽愷澤®2024630賽愷澤®75CAR-T 2. 20246302 3. 2024630352202363040452(i)2024630920236301910(ii)(iii)20246306 2024630(1)342202363038644(i)(ii)20246306 4. 20246301,653202312311,85019720241,3502027 (1) ၍ଣᄴীሞʿʱؓ I. CAR-TCAR-TCAR-T II. CAR-TCAR-T LUMMICAR-2 CT071GPRC5DCARcelerate®CT071GC/GEJII(CT041-ST-01NCT04581473)CAR-TIICAR-T ၍ଣᄴীሞʿʱؓ 1. 2.II HK Inno.N Corporation195940 賽愷澤®CT053BCMA CAR-T 賽愷澤®R/R MMBCMA CAR-TBCMA(scFv)CARCAR-TT 202431NMPA賽愷澤®2024223R/RMM320231賽愷澤®200751,025賽愷澤®賽愷澤®2024731賽愷澤®201910052 賽愷澤® LUMMICAR-1202461529EHABCMACAR-T2Phase 2 studyoffully human BCMA-targeting CAR-T cells(zevorcabtageneautoleucel)in patients with relapsed/refractory multiple myeloma102賽愷澤®ORR92.2% (94/102)VGPR91.2% (93/102)CR/sCR71.6% (73/102) 20231265ASHLummicar1I3Three-Year Follow-Up onEfficacy and Safety Results from Phase 1 Lummicar Study 1 of Zevorcabtagene Autoleucel in ChinesePatientswith Relapsed or Refractory Multiple MyelomaI/II(LUMMICAR-1, NCT03975907)I3 RTPCMCLUMMICAR-2FDALUMMICAR-2 18A.08(3) Claudin18.2 CAR-T Claudin18.2CAR-TClaudin18.2GC/GEJPCClaudin18.2GC/GEJPCCAR-TClaudin18.2CAR-TCAR-TFNC GC/GEJII(CT041-ST-01,NCT04581473)2025NMPANDA ၍ଣᄴীሞʿʱؓ PCI(CT041-ST-05NCT05911217)GC/GEJ Ib/II(CT041-ST-01NCT04581473)Ib2022ASCOCLDN18.2 CAR TCT041lb/ll“Safety, Tolerabilitv and Preliminary Efficacy Results inPatients with Advanced Gastric/Gastroesophageal Junction Adenocarcinoma from a Phase lb/ll Study ofCLDN18.2 CAR T-cell therapy (CT041)” CT041-CG4006202463NatureMedicineClaudin18.2 CAR-TI“Claudin18.2-specific CART cells in gastrointestinal cancers: Phase 1 trial final results”202462024ASCOGC/GEJn=5951ORRDCR54.9% (28/51)96.1% (49/51) 1b/2CT041-ST-02NCT04404595GC/GEJ2RTPCMCFDA1b2024ASCOGICLDN18.2TELIMYN18.2 1b“CLDN18.2 ChimericAntigen Receptor T Cell Therapy for Patients with Advanced Gastric and Pancreatic Adenocarcinoma:Results of ELIMYN18.2 Phase 1b Clinical Trial” 20245CT041“Safety and Efficacy of CT041 in Patients With Refractory Metastatic Pancreatic Cancer: A PooledAnalysis of Two Early-Phase Trials”)Journal of Clinical OncologyI/IbCT041-CG4006CT041-ST-01 20239NCT04581473NCT03874897Journal of Hematology & OncologyCT041 CAR-TClaudin18.2“CT041 CAR T cell therapy for Claudin18.2-positive metastaticpancreatic cancer” 2 0 2 42C l a u d i n 1 8 . 2 - C A RT“ M e t a s t a t i cgastriccancer target lesion complete response with Claudin18.2-CAR T cells”Journal forImmunoTherapyof Cancer28 GC/GEJ20209FDA20212EMA202111EMAPRIMEClaudin18.220221FDARMAT Claudin18.2mRNA2023 18A.08(3) CT011GPC3 CAR-T CT011CAR-T(HCC)GPC3CAR-THCC 20241CT011NMPAINDGPC3IIIa 20237CAR-GPC3 T”Combined local therapy and CAR-GPC3 T-cell therapy in advanced hepatocellular carcinoma: a proof-of-concepttreatment strategy“Cancer Communication2GPC3 CAR-THCC7 18A.08(3)CT011 CT071GPRC5D CAR-T CT071CARcelerate®GPRC5DCAR-T(scFV)R/R MMR/R pPCL CARcelerate®CT07130CAR-T ၍ଣᄴীሞʿʱؓ R/RMMR/RPCL(NCT05838131)2024629EHAGPRC5DCAR-T(CT071)“First-in-human study of GPRC5D-targeted CAR T cells (CT071) with anaccelerated manufacturing process in patients with relapsed/refractory multiple myeloma (RRMM)”2024 (NDMM)(NCT06407947)CT071202311FDAINDR/R MMR/R pPCLRTPCMCCT0711FDA 18A.08(3)CT071 IND IND CT048CycloCAR®CAR-TClaudin18.2GC/GEJPCIL-7CCL21CT048CT048GC/GEJPC CT0590THANK-uCAR®BCMACAR-TCT0590R/RMM2024 KJ-C2114THANK-uCAR®CAR-T KJ-C2219CD19/20CAR-T KJ-C2320CAR-T2024 CAR-T CAR-TCAR-T CAR-T (1)CAR-TCAR-TTHANK-uCAR®THANK-uCAR®TCAR-TT(GvHD)(HvGR)TCRβ2(B2M)TCRI(HLA-I)(NK)HLA-ITCAR-TCAR-TNKNKG2ACARTCR-/HLA-I-TNKG2ANKCAR-TTHANK-uCAR-TNKNKG2ACARTCR-/HLA-I-TNKTHANK-uCAR®CAR-TCAR-T (2)C A R - T3 0CARcelerate®CAR-TCARcelerate®CAR-TCARcelerate®CT071MMpPCL ၍ଣᄴীሞʿʱؓ (3) •CycloCAR®CAR-TIL-7CCL21IL-7CAR-TCAR-TCCL21TCAR-TCycloCAR-TCycloCAR-TIL-7CCL19CAR-T7×19 CAR-TCycloCAR-TTCycloCAR-TCycloCAR®Claudi