嘉和生物-B2023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 2023中 期 報 告 2 5 7 8 11 23 45 46 48 50 51 52 72 2007CMC 20222023 2023ASCO(GB491,Lerociclib)LEONARDA-1(PosterDiscussion Session)ASCOASCODaily NewsHRHER2LEONARDA-12023525(GB491,Lerociclib) LEONARDA-1(GB491, Lerociclib)HR+HER2NDACDK4/6 GB261CD20/CD3GB263TEGFR/cMET/cMET FICT(T-cell engager)ADCFICBICFICIND enabling mRNA 20 (1)G1 Therapeutics, Inc.GTHX(2)ImmuneSensor Therapeutics*5 22 Maples Corporate Services LimitedPO Box 309, Ugland HouseGrand CaymanKY1-1104Cayman Islands 6906401-17201203 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 •20226303.0•224.82022630295.1(i)(ii)(iii)•276.42022630407.5•(1)237.92022630365.8(1) (GB491, Lerociclib)CDK4/6 •(GB491, Lerociclib)3 •2023328NMPA(GB491, Lerociclib)HR+HER2-NDA •202362662023ASCO(GB491, Lerociclib) •HR+HER2IIILEONARDA-1(PosterDiscussionSession) •LEONARDA-1IIIASCOASCODaily NewsHRHER22023525 •LEONARDA-1 •LEONARDA-1(GB491, Lerociclib)HR+HER2CDK4/6 GB261CD20/CD3BICCD20/CD3 •2023630GB261CD20/CD3I/II•G B 2 6 1C D 2 0 / C D 3C D 2 0 / C D 3mosunetuzumabCAR-TCD3/CD19•CD20/CD3(CRS)12.8%18.5%24.3%3IL-6(PK)•ICANS•10RP2D2023 GB263TEGFR/cMET/cMET •2023630GB263TEGFR/cMET/cMETI/IIDLT•GB263TEFGR/cMET/cMETEGFRCMET3TKIEGFRNSCLCGB263TPR24•IRR35.7%66%1/2MET •FICFIC/BICT-cellengagerADC •202363010FICIND enabling•20236305FIC/BIC10•GB268IND enabling • •CMCGB261CD20/CD3GB263TEGFR/cMET/cMET 1. •• NMPA(GB491, Lerociclib)NDA 1)(GB491, Lerociclib)2)GB261CD20/CD3I/II3)GB263TEGFR/cMET/cMETI/IIDLT (GB491,Lerociclib)CDK4/6CDK4/6 (GB491,Lerociclib)CDK4/6G1 Therapeutics III 2023328NMPA(GB491, Lerociclib)HR+HER2NDA 202362662023ASCO(GB491, Lerociclib) •HR+HER2IIILEONARDA-1(PosterDiscussionSession) •LEONARDA-1IIIASCOASCODaily NewsHRHER22023525 •LEONARDA-1 •LEONARDA-1(GB491, Lerociclib)HR+HER2CDK4/6 (GB491, Lerociclib)HR+HER2 •HR+HER2CDK4/6 •PK/PDCDK4/6 •LEONARDA-1(HR)0.451(BICR)HR0.353(mPFS)11.07 vs. 5.49BICRmPFS11.93 vs. 5.75 •LEONARDA-1CDK4/619.7%III/IVIV5.1% •LEONARDA-1≥4(PFS) (GB491,Lerociclib)20236302023(GB491, Lerociclib) GB261CD20/CD3 GB261CD20/CD3CD3FcADCCCDCT(T-cellengager)GB261 CD20/CD3rituximabTGB261CD20/CD3BCD3/CD20GB261T 12GB261CD20/CD3FIH3mgPOCGB261CD20/CD3 2023630GB261CD20/CD3I/IIGB261CD20/CD3CD20/CD3mosunetuzumabCAR-TCD3/CD19 CD20/CD3CRS12.8%18.5%24.3%3IL-6ICANS PKGB261CD20/CD3 GB261(CD20/CD32023(RP2D)2023 GB261CD20/CD3202363020232024 GB263TEGFR/cMET/cMET GB263TEGFR/cMET/cMETEGFR/cMET/cMETEGFRcMETGB263TEGFR/cMET/cMETEGFRcMET Amivantamab(JNJ-372)GB263TEGFR/cMET/cMETEGFRc-METEGFRcMETGB263TEGFR/cMET/cMETEGFRcMETEGFRcMETGB263TEGFR/cMET/cMETEGFR20EGFR19C797ScMET 2023630GB263TEGFR/cMET/cMETI/IIDLTGB263TEFGR/cMET/cMETEGFRCMET3TKIEGFRNSCLCGB263TPR24 GB263TEFGR/cMET/cMETIRR35.7%66%1/2MET 2023POC GB492(IMSA101STING G B 4 9 2 ( I M S A 1 0 1 )2 0 2 06I m m u n e S e n s o rTherapeutic STINGSTINGcGAS-STING(ICI)FIC GB492(IMSA101)®GB2261/2(CDE)400ugGB492(IMSA101)PD-1 FICFIC/BIC 2023630 •5FIC/BIC •10•GB268IND enabling •2023630®GB242269 ®GB226 20236NMPA®GB226T(PTCL)NDA GB221Her2 HER2+GB221Her2IIIGB221-004 CMC CMC • • •MAH 2. FICIND enabling 18A.08(3) CMC FICBIC FIC T-cellengagerADC (GB491,Lerociclib)HR+HER23NDA(GB491,Lerociclib)HR+HER2NDA GB261CD20/CD3I/IIGB263TEGFR/cMET/cMETPOC GB261CD20/CD3GB263TEGFR/cMET/cMET 2022630 20226303.0 20226300.8 202263063.0 202263084.113.7%72.6 2022630295.123.8%224.8(i)(ii)(iii) 2022630 2022630406.6275.0 202212311,588.720236301,362.0 202363020221231 1.2.3. 20236305% 2023630 202363020221231 202363010%20.72022123122.6 2023630222202212312641318832023630 128.32022630221.8 2023630 2021D.2021202163202182720221052023525 2023630XV352 (1)2023630506,246,741 (2)MaplesFS (BVI) LimitedAKQM Partner Trust11,289,1495,000,000 2023630352 2023630336 1.2023630506,246,741 2.HHJHHoldings LimitedHHBIO Investment Fund,L.P.HHBIOHH BIOHHBIOHoldingsGP,Ltd.HHBIOHH BIOHillhouseFund IV,L.P.HillhouseFund IVHillhouse InvestmentManagement, Ltd.Hillhouse Fund IVHillhouse Investment Management, Ltd.0.34%3.30014237,560,9984.ArandaInvestments Pte.Ltd.ArandaInvestmentsAranda InvestmentsSeletar Investments Pte LtdTemasek Capital (Private) LimitedTemasek Capital (Private) LimitedTemasek Holdings (Private) LimitedTemasek Holdings(Private) Limited0.39% 2023630336 1. 201981920204162020731 (a) (b) (c) 58,573,872202383011.57%506,337,036 (d) (e) (f) (g) 202981920238306.0 (h) (1)(i)(ii)1%(iii)1217.070.1%(2)(3)MaplesFS (BVI) LimitedAKQM Partner Trust(4)2.2408 2. 2020918 (a) (b) 17 (c) 48,109,1502023830506,337,0369.50% (d) 1% (e) (10) 17 (f) (g) 17(i)(ii)(iii) (h)203010720238307.1 (1)(i)(ii)1%(iii)17.07120.1%(2) (j)11,600,00020235251.81 (i)(ii) i.B+100%ii.B60%iii.Biv. 20235250.66370.854912 20231120236304