嘉和生物-B2024中期报告

（於開曼群島註冊成立的有限公司） 股份代號: 6998 2024中期報告 2 5 7 8 11 27 53 54 56 58 59 60 78 2007CMC 202220232024 202482GB261(CD20/CD3GB261(CD20/CD3BIC CD20/CD3GB261CD20/CD3 GB261(CD20/CD320241FGFR2bIP (GB491, Lerociclib)2024228NDA20243132023328(GB491,Lerociclib)NMPA(HR)2(HER2)(HR+HER2-)(GB491, Lerociclib)20243NDA20245 EGFR/cMET/cMETGB263T(1,260-1,680mg)2024ESMO FICBIC5PCC22024AACRGB268PD-1CTLA-4VEGF 20 (1)G1 Therapeutics, Inc.GTHX(2)ImmuneSensor Therapeutics(3)GB226 PD-1GB221***5 202412202412 20249122024912 22 202412202412 2024918 Maples Corporate Services LimitedPO Box 309, Ugland HouseGrand CaymanKY1-1104Cayman Islands 2024918 6906501-02201203 202412202412 3485 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 •14.52023630•109.72023630224.8(i)(ii)•132.32023630276.4•(1)121.42023630237.9(1) (GB491, Lerociclib)CDK4/6CDK4/6 •(GB491,Lerociclib)2024228NMPANDA2024313 •IDMCIDMC •PFSHR(95% CI)p0.464 (0.293,0.733)p=0.0004 •IRCPFSHR(95% CI)p0.457 (0.274, 0.761)p=0.0011 •20246ASCO •NMPA3(GB491,Lerociclib)(HR)2(HER2)(HR+HER2-)820243(GB491, Lerociclib)NDA20245 GB263TEGFR/cMET/cMET •2023123115GB263T3EGFR-TKI3 •GB263T(1,260-1,680mg) ➢EGFR3TKIORR30% ➢33TKIcMET • ➢➢1/21➢MET 2024(ESMO)2024914 •FIC •2024630 •5PCC ➢GB268INDenablingCMCPK/ADA4 •22024AACR •GB268PD-1CTLA-4VEGFPD-1CTLA-4VEGFPD-1/VEGFPD-1/CTLA-4GB268 •2024119IP CMC CMC • ••MAHGMPCDMO•CMCGB261CD20/CD3GB263TEGFR/cMET/cMETGB268 1. •• (GB491, Lerociclib)NMPA 1)(GB491,Lerociclib)HR+HER2-202432)(GB491,Lerociclib)HR+HER2-202435NDA3)GB263TEGFR/cMET/cMETI/II2024ESMO2024914 (GB491, Lerociclib)CDK4/6CDK4/6 (GB491,Lerociclib)CDK4/6G1 Therapeutics Inc. 3(GB491,Lerociclib)HR+HER2-820243(GB491,Lerociclib)NDA20245 (GB491,Lerociclib)III2024228NMPANDA2024313 •IDMCIDMC •PFSHR(95% CI)p0.464 (0.293,0.733)p=0.0004 •IRCPFSHR(95% CI)p0.457 (0.274, 0.761)p=0.0011 •20246ASCO (GB491,Lerociclib)HR+HER2- •HR+HER2-CDK4/6•PK/PDCDK4/6 •LEONARDA-1+HR0.451 BICRHR 0.353mPFs11.07 vs. 5.49BICRmPFS11.93 vs. 5.75 •LEONARDA-1CDK4/619.7%3/445.1% •LEONARDA-1≥4PFS •LEONARDA-2HR+HER2- •50%PFSHR(95%CI)p0.464(0.293,0.733)p=0.0004 mPFSPFSHR(95% CI)p0.457 (0.274, 0.761)p=0.0011 •AE1(0.7%)3≥345.1% (GB491,Lerociclib)2024630(term sheet) (GB491, Lerociclib) GB261CD20/CD3 GB261(CD20/CD3CD3FcADCCCDCTCEGB261CD20/CD3rituximabTGB261CD20/CD3BCD3/CD20GB261CD20/CD3TCE GB261CD20/CD3FIH3mgPOCGB261CD20/CD3202310GB261 I/II GB261(CD20/CD365I/II •GB261CD20/CD3Fc+ CD20/CD3 TCEBNHLGB261CD20/CD3GB261CRSGB261CD20/CD3GB261GB261 GB261(CD20/CD3I/IICSR GB263TEGFR/cMET/cMET GB263TEGFR/cMET/cMETEGFR/cMET/cMETEGFRcMETGB263TEGFR/cMET/cMETEGFRcMET Amivantamab(JNJ-372)GB263TEGFR/cMET/cMETEGFRcMETEGFRcMETGB263TEGFR/cMET/cMETEGFRcMETEGFRcMETGB263TEGFR/cMET/cMETEGFR20EGFR19C797ScMET •2023123115GB263T3EGFR-TKI3 •GB263T(1,260-1,680mg) ➢EGFR3TKIORR30% ➢33TKIcMET • ➢➢1/21➢MET •2024(ESMO)2024914 FIC •2024630 •5PCC ➢GB268IND enablingCMCPK/ADA4 •22024AACR •PO.IM01.06 GB268PD-1/CTLA-4/VEGF ➢ p d 1 / P D - L 1P D 1C T L A 4(irAEs)PD-1/CTLA-4(Cadonilimab)VEGFVEGF(bevacizumab)PD-1/PD-L1GB268PD-1CTLA-4VEGF ➢ GB268pd-1VHHCTLA-4VHHVEGFFCL234A/L235A ➢ GB268PD-1VEGFCTLA-4PD-1VEGFCTLA4AEsCTLA-4CTLA4CD80/CD86CTLA-4PD-1GB268PBMCA375HT29NCI-H460NSCLCPD-1/CTLA-4bsAbPD-1/VEGFbsAbPD-1CTLA-4VEGFGB268hPD1/hCTLA4KIGB268(cadonilimab)(ipilimumab)OPDIVO20 GB268FICpd-1/CTLA-4/VEGFGB268(AEs)GB268 •2LBPO.IM02 GBD218BCMAGPRC5DT(TCE) ➢ MM10%MMBCMAGPRC5DCAR-TTTCEMMBCMAGPRC5DMMTCEGBD218BCMAGPRC5D ➢ BCMAGPRC5DPBMC ➢ GBD218hBCMAKD=0.4nMhGPRC5DEC50 ~ 2nMCRSTCEsAEsGBD218CD3GBD218BCMAGPRC5DMMCRSGBD218(teclistamab)(Talquetamab)GBD218BCMAGPRC5DGBD218GBD218MM GBD218GBD218BCMAGPRC5DMMMM 2024119FGFR2bIP CMC CMC • • •MAHGMPCDMO •CMCGB261CD20/CD3GB263TEGFR/cMET/cMETGB268 2. •202482GB261GB261(CD20/CD3 •(1)(2)(3)4.43(4) •20249122024912 •20249122024912 •202491820249182024918(i)3.10(1)(ii)3.10A20249182024923 18A.08(3)®GB242 FICBIC FIC (GB491, Lerociclib)HR+HER2-(GB491,Lerociclib)HR+HER2-(GB491, Lerociclib)(GB491, Lerociclib)(GB491, Lerociclib)2027 GB261GB268TCEGB263TEGFR/cMET/cMET 2023630 14.52023630 0.32023630 202363072.647.0%38.5 2023630224.851.2%109.7(i)(ii) 2023630 2023630275.0126.3 2024630 202312311,165.520246301,026.6 202420236301231 1.2.3. 20246305% 2024630 20244152013123015 202463020231231 202463010%95.442023123118.46 202463028202312311042712024630 (%) 53.02023630128.3 2024630 20212023202320212023102720212021 D.2021202163202182720221052023202320231012 2024630XV352 (1)2024630514,063,591 (2)(i)MaplesFS (BVI) LimitedAKQM Partner Trust4,920,0954,442,4162024410(ii)5,000,000(iii)20235,579,054(iv)20234,210,000 2024630352 2024630336 1.2024630514,063,5912.HHJHHoldings LimitedHHBIO Investment Fund,L.P.HHBIOHH BIOHHBIOHoldingsGP,Ltd.HHBIOHH BIOHillhouseFund IV,L.P.HillhouseFund IVHillho