嘉和生物-B2023年度报告

嘉和生物藥業(開曼)控股有限公司GENOR BIOPHARMA HOLDINGS LIMITED 2 5 7 8 13 31 65 98 100 102 103 183 2007152007 2023 (GB491,Lerociclib)GB261 CD20/CD3GB263TEGFR/cMET/cMET •2023ASCO(GB491,Lerociclib)LEONARDA-1(Poster Discussion Session)ASCOASCO Daily News(GB491, Lerociclib) •2023129-1265(ASH)GB261CD20/CD3I/II •2023121AACRMolecularCancer TherapeuticsEGFR/cMET/cMETGB263TI/II •202311152023SITC38 (GB491, Lerociclib)2023328NMPA(HR)2(HER2)(HR+HER2-) (GB491, Lerociclib)III2024228NMPANDA2024313 GB261CD20/CD3GB263TEGFR/cMET/cMETI/II FICBIC5PCC22024AACRIND IP 20 (1)G1 Therapeutics, Inc.GTHXG1 Therapeutics(2)ImmuneSensor Therapeutics*5 202412202412 202412202412 22 Maples Corporate Services LimitedPO Box 309, Ugland HouseGrand CaymanKY1-1104Cayman Islands 6906401-17201203 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 •2022123115.9•564.320221231583.9(i)(ii)(iii)•676.020221231731.8•(1)614.320221231682.2(1)20232022 (GB491,Lerociclib)CDK4/6CDK4/6 •(NMPA)2023328(GB491Lerociclib)(HR)2(HER2)(HR+HER2-)2023 •202362662023(ASCO)(GB491, Lerociclib) •LerociclibHR+HER2IIILEONARDA-1(PosterDiscussionSession) •LEONARDA-1IIIASCOASCODaily NewsHRHER22023525 •LEONARDA-1 •LEONARDA-1(GB491, Lerociclib)HR+HER2CDK4/6 •(GB491,Lerociclib)III GB261(CD20/CD3CD20/CD3 •GB261(CD20/CD3I/IIFIH3mgPOC •202310GB261 I/IICD20/CD3(mosunetuzumab)CAR-T CD3/CD19 •2023129-1265(ASH)GB261(CD20/CD3I/II •GB261FcCD3CD20/CD3BFIH1719 •CRS1(8.5%4/47)2(4.3%2/47)3CRS(Lee et al., ASTCTCRS7ICANS •PK2-33-4 •B-NHLGB261(CD20/CD3CD20/CD3GB261(CD20/CD3CRSGB261(CD20/CD3CD20/CD3GB261(CD20/CD3 GB263TEGFR/cMET/cMET 20238I/II1,680mg •Amivantamab(JNJ-372)GB263TEGFR/cMET/cMETEGFRc-METEGFRcMETGB263TEGFR/cMET/cMETEGFRcMETEGFRcMETGB263TEGFR/cMET/cMETEGFR20EGFR19C797ScMET •2023121AACRMolecular Cancer TherapeuticsEGFR/cMET/cMETGB263TI/II •EGFR(EGFRm)(NSCLC)EGFR/cMET/cMETGB263TI/IIC114 •GB263T(EGFR/cMET/cMET(1,260-1,680mg) •( I R R )3 5 . 7 %(66%)1/2MET •FIC •202311152023SITC38 •GBD201CCR8/CTLA-4491 GBD201CCR8/CTLA-4CTLA-4ipilimumabtremelimumab •GBD209PD-1/CTLA-4/TIGIT492 GBD209TPD-1/CTLA-4/TIGITT •20231231 •5PCC •22024AACR •GB268(IND Enabling) ®(GB24226 CMC •CMCGB261(CD20/CD3GB263T(EGFR/cMET/cMETGB268 •(GB491, Lerociclib)III2024228NMPANDA2024313•2024119IP 1. •• (GB491, Lerociclib)NDANMPA 1)(GB491,Lerociclib)III2023162)GB261(CD20/CD3I/II3)GB263T(EGFR/cMET/cMETI/II1680mg (GB491,Lerociclib)CDK4/6CDK4/6 (GB491,Lerociclib)CDK4/6G1 Therapeutics III 2023328(GB491,Lerociclib)HR+HER22023 202362662023ASCO(GB491, Lerociclib) •LerociclibHR+HER2IIILEONARDA-1(PosterDiscussionSession) •LEONARDA-1 IIIASCOASCO Daily NewsHRHER2525 •LEONARDA-1 •LEONARDA-1(GB491,Lerociclib)HR+HER2CDK4/6 (GB491, Lerociclib)HR+HER2 •HR+HER2CDK4/6•PK/PDCDK4/6•LEONARDA-1+HR0.451 BICRHR0.353mPFS11.075.49BICRmPFS11.935.75•LEONARDA-1CDK4/619.7%1/23/445.1%•LEONARDA-1≥4PFS•(GB491,Lerociclib)III•2024228NMPA(GB491,Lerociclib)NDA2024313 (GB491, Lerociclib) (GB491, Lerociclib) GB261CD20/CD3CD20/CD3 GB261(CD20/CD3CD3FcADCCCDCT(T-cellEngager)GB261 CD20/CD3rituximabTGB261CD20/CD3BCD3/CD20GB261CD20/CD3T GB261CD20/CD3I/IIFIH3mgPOC 202310GB261CD20/CD3I/IICD20/CD3(mosunetuzumab)CAR-T CD3/CD19 2023129-1265(ASH)GB261(CD20/CD3) I/II •GB261FcCD3CD20/CD3BFIH1719 •202361747r/rB-NHLBDLBCL:76.6%;FL:23.4%)GB261CD20/CD31mg300mg 3mg100mg(n=22)ORR73%(16/22)CRR45.5%(10/22) •(n=47)12.8%(6/47)CRS100mgCRS14.3%(2/14)CRS1(8.5%4/47)2(4.3%2/47)3CRS(Leeet al.,ASTCTCRS7ICANS •PKGB261CD20/CD3PK(1mg -100mg)2-33-4 •B-NHLGB261CD20/CD3CD20/CD3GB261CD20/CD3CRSGB261CD20/CD3CD20/CD3GB261CD20/CD3GB261CD20/CD3 GB261CD20/CD3202312312024 GB263TEGFR/cMET/cMET GB263TEFGR/cMET/cMETEGFR/cMET/cMETEGFRcMETGB263TEGFR/cMET/cMETEGFRcMET Amivantamab(JNJ-372)GB263TEGFR/cMET/cMETEGFRc-METEGFRcMETGB263TEGFR/cMET/cMETEGFRcMETEGFRcMETGB263TEGFR/cMET/cMETEGFR20EGFR19C797ScMET 20238GB263TEGFR/cMET/cMETI/II1680mg1260mg1680mg 2023121AACRMolecularCancer TherapeuticsEGFR/cMET/cMETGB263TI/II •EGFR(EGFRm)(NSCLC)GB263TFIHI/IIC114 •GB263T(1260-1680mg) •IRR35.7%(66%)1/2MET •20237513140mg(n=1)420mg(n=1)840mg(n=3)1260mg(n=3)1680mg(n=5)1680mgEGFR-TKI31-7)11680mgGB263TEGFR/cMET/cMET(DLT)3TRAEs(61.5%)IRR(38.5%)(30.8%)(23.1%)(1/21≥3TRAE3102PR4SD4SD3(DCR)60%(1260-1680mg)40%(2/5)2PR2SD FIC 202311152023SITC38 •GBD201CCR8/CTLA-4491 GBD201CCR8/CTLA-4CTLA-4ipilimumabtremelimumab •CCR8TTregGBD201CCR8TregCTLA-4armpartialblockerCTLA-4CD80/CD86GBD201CCR8CTLA-4CTLA-4 •GBD201CCR8CTLA-4VHH1GBD201CCR8+CTLA4-4+ADCCTregs2 GBD201TregCCR8CCL1Treg3GBD201CTLA4CTLA-4CD80/86CCR8CTLA-4CTLA-4 •hCCR8/hCTLA-4double KIGBD201MB49MC38IpilimumabIpilimumabanti-CCR8(TIL)GBD201TregCD8+TGBD201hCCR8/hCTLA-4Ipilimumab(20mpk)PD1GBD201(23.3 mpk)5(116.7mpk)PD1GBD201Ipilimumab5 •GBD209PD-1/CTLA-4/TIGIT492 GBD209TPD-1/CTLA-4/TIGITT •GBD209VHHGBD2091)PD-1TIGITCTL