嘉和生物-B2025中期报告

嘉和生物藥業(開曼)控股有限公司GENOR BIOPHARMA HOLDINGS LIMITED （於開曼群島註冊成立的有限公司） 股份代號: 6998 2025中期報告 268913295657585961626374 2007CMC 2022202312025527NMPA(HR)2(HER2)(HR+HER2-) 202491320251242025415 202512GBD218CD3/BCMA/GPRC5DGBD220CD3/CD19/BCMAPCC 2025528GB491(GB491)MAH(GB491) 202571(GB491)(GB491)202571GB268GB268 2025714(GB491)(GB491) (GB491)NMPA2024313(GB491)(HR)2HR+HER2-NDA2025527NMPA 2023328NMPA(GB491)HR+HER2-NDA2025527NMPA (NatureCommunications)2025116(GB491)HR+HER2-LEONARDA-1III(LEONARDA-1) GB268PD-1/VEGF/CTLA-4PD-1VEGFCTLA-4PD-1CTLA-4VEGFPD-1/VEGFPD-1/CTLA-4GB268GB268202534GLP20252GMPNMPA202559GB268PD-1/VEGF/CTLA-4IND2025717IND GB261(CD20/CD3I/IIGB261GB261 I/II65(ASH)20256GB261CandidTherapeutics, Inc.Candid Therapeutics, Inc.TGB261GB261GB261 EGFR/cMET/cMETGB263T(1,260-1,680mg) FICBICPCC (1)CandidTherapeutics,Inc.GB261(2)Candid Therapeutics, Inc.I(3)GBD218* GB226 PD-1GB221 2025626 97927 Maples Corporate Services LimitedPO Box 309, Ugland HouseGrand CaymanKY1-1104Cayman Islands 6906501-02201203 20256262025626 331919202025110 8111101-1104 Maples Fund Services (Cayman) LimitedPO Box 1093Boundary HallCricket SquareKY1-1102Cayman Islands 520100020 183171712-1716 1826 JP Morgan Chase Bank N.A.Hong Kong Branch228 1192 6998 www.genorbio.com •32.2TRC2004,Inc.202463014.5•74.62024630109.7(i)(ii)•54.32024630141.0•(1)59.62024630130.2(1) 12025527NMPAHR2HER2HR+/HER2-(GB491)(GB491)(GB491)GB268PD-1/VEGF/CTLA-4INMPAFIHGB261CD20/CD3 •202491377%23% •20251242025415202512420254152025415 •2025825 •202512GBD218CD3/BCMA/GPRC5DGBD220CD3/CD19/BCMAPCC2025124 •2025528GB491(GB491)MAH(GB491) •202571(GB491)(GB491)202571GB268GB268 •2025714(GB491)(GB491) GB491CDK4/6CDK4/6 •( G B491)NMPA2024313(GB491)HR+HER2-NDA2025527NMPA •NMPA2023328(GB491)HR+HER2-NDA2025527NMPA•(NatureCommunications)2025116(GB491)HR+HER2-LEONARDA-1III(LEONARDA-1) GB268PD-1/VEGF/CTLA-4 •GB268PD-1CTLA-4VEGFPD-1CTLA-4 VEGFPD-1/VEGFPD-1/CTLA-4GB268 •GB26820252GMP202534GLPTNMPA202559GB268PD-1/VEGF/CTLA-4IND2025717NMPAFIH I GB261 (CD20/CD3 •GB261CD3FcADCCCDCTCETGB261I/IIGB261GB261I/II65(ASH)20256GB261Candid Therapeutics, Inc.Candid Therapeutics, Inc.TCEGB261GB261GB2612025630 GB263TEGFR/cMET/cMET •GB263TEGFR/cMET/cMETEGFR/cMET/cMETEGFRcMETGB263TEGFRcMET •GB263TI/III15GB263T3EGFR-TKI3 •GB263T(1,260-1,680 mg) • •2024(ESMO)2024914 •FIC/BICPCC CMC •CMC •••MAHGXPCDMOGXP•CMCGB261CD20/CD3GB263TEGFR/cMET/cMETGB268PD-1/VEGF/CTLA-4CMC 1. 2024913202512420254152025124202541520254152025825 202512GBD218CD3/BCMA/GPRC5DGBD220CD3/CD19/BCMAPCCGBD220GDB2182025124 2025528GB491(GB491)MAH(GB491) •• 1)12025527NMPA(HR)2(HER2)(HR+HER2-) 2)GB268PD-1/VEGF/CTLA-42025CMC2GMPGLP202559NMPA(FIH)(IND) 3)GB261(CD20/CD3Candid Therapeutics, Inc.TGB261GB261GB261 (GB491)CDK4/6CDK4/6 (GB491)CDK4/6G1 Therapeutics NMPA2023328(GB491)HR+HER2-NDA2025527NMPA NMPA2024313(GB491)HR+HER2-NDA2025527NMPA (GB491)HR+HER2- •HR+HER2-CDK4/6 •P K /PDCDK4/6 •(GB491)3 •L E O N A R D A -1+HR+HER2-HR0.451BICRHR0.353mPFS11.07vs.5.49 BICRmPFS11.93vs.5.75≥4PFSLEONARDA-1CDK4/619.7%3/445.1% •LEONARDA-2HR+HER2- •50%PFS(95% CI)p0.464 (0.293, 0.733)p=0.0004 mPFS16.56BICRPFS(95%CI)p0.457 (0.274, 0.761)p=0.0011 •AE1(0.7%)3≥345.1% (NatureCommunications)2025116(GB491)HR+HER2-LEONARDA-1III(LEONARDA-1)LEONARDA-1(ClinicalTrials.gov identifier,NCT05054751) (GB491) (GB491) GB268 (PD-1/VEGF/CTLA-4 GB268PD-1VEGFCTLA-4CTLA4CTLA-4CTLA4CD80/CD86CTLA-4PD-1GB268GB268 •PBMCA375HT29NCI-H460NSCLCPD-1/CTLA-4 BsAbPD-1/VEGF BsAbPD-1CTLA-4 VEGFGB268•hPD1/hCTLA4 KIGB268(Cadonilimab)(ipilimumab)OPDIVO20 GB26820252GMP202534GLPT NMPA202559GB268PD-1/VEGF/CTLA-4IND GB261(CD20/CD3 GB261(CD20/CD3CD3FcADCCCDCTTCEGB261rituximabTGB261BCD3/CD20GB261TCE GB261I/IIGB261 GB261 I/II65(ASH) •GB261CD20/CD3Fc+ CD20/CD3 TB-NHLGB261CD20/CD3GB261CRSGB261CD20/CD3GB261GB261 Candid Therapeutics, Inc.TCEGB261GB261GB2612025630 GB263TEGFR/cMET/cMET GB263TEGFR/cMET/cMETEGFR/cMET/cMETEGFRcMETGB263TEGFRcMET Amivantamab(JNJ-372)GB263TEGFRcMETEGFRcMETGB263TEGFRcMETEGFRcMETGB263TEGFR20EGFR19C797ScMET GB263T I/III15GB263T3EGFR-TKI32024(ESMO)2024914 •GB263T(1,260-1,680 mg) •EGFR3TKI1,260/1,680 mgORR28.6%•33T K Ic M E T2PR1SD12840mgSD101,260 mgPR81,680 mgPR • •(33.3%)≥310%1 •AE(60%)(40%)(40%)1/2•MET FIC/BICPCCPCC CMC CMC • • •MAHGXPCDMOGXP •CMCGB261CD20/CD3GB263TEGFR/cMET/cMETGB268PD-1/VEGF/CTLA-4 202511033191920202519 2025219202521920251222025219202524 2. •202571(GB491)(GB491) •202571GB268GB268•2025714(GB491)(GB491)•2025717GB268 FIH INDNMPA 18A.08(3)®GB242 FICBIC FIC/BIC 2025(GB491)2025(GB491)2025(GB491)GB268FIHGB263TEGFR/cMET/cMET 32.2TRC 2004, Inc.202463014.5 20246300.3 202463038.534.8%25.1 2024630109.732.0%74.6(i)(ii) 2024630 2024630135.154.4 2025630 202412311,058.820256301,009.9 202520246301231 1.2.3. 20256305% CandidTherapeutics,Inc.CandidCandidTTRC2004,Inc.TRCTRC202485 TRCCandid202563012,500,000CandidCandid2.29%2024123183,732,000202563083,844,00020256301,324,798,0006.33%Candid