和誉-B2023 中期报告

和譽開曼有限責任公司Abbisko Cayman Limited 股份代號 : 2256（於開曼群島註冊成立的有限公司） 2023中 期 報 告 2479255455565860 Abbisko Cayman LimitedP.O. Box 309Ugland HouseGrand CaymanKY1-1104Cayman Islands 2023619 8983 24840 Maples Fund Services (Cayman) LimitedPO Box 1093, Boundary HallCricket SquareGrand CaymanKY1-1102Cayman Islands 183171712-1716 Davis Polk & Wardwell3A10 5047518001 979127 2256 www.abbisko.com 2023630 2023 Pimicotnib (ABSK021) TGCTPimicotinibIII1005030Pimicotinib20227202023130FDABTDTGCT20236EMAPRIME 20231PimicotinibcGvHDIIPimicotinibCSF-1R 20231PimicotinibFDABTDTGCTBTDPimicotinibIb 20233PimicotinibFDATGCTIII 20234PimicotinibIIIPimicotinibTGCT 202352023ASCOCSF-1RPimicotinibTGCTIbPimicotinibTGCTPoster Bd#: 493EFFICACY AND SAFETY PROFILE OF PIMICOTINIB(ABSK021) IN TENOSYNOVIAL GIANT CELL TUMOR (TGCT): PHASE 1B UPDATEPimicotinib50mgORR77.4%RECIST1.1Pimicotinib89.8%50mg9.312.5 20236PimicotinibEMAPRIMETGCTPRIMEPimicotinibTGCTIbPRIMEBTD 20236PimicotinibIIPimicotinibTGCTcGvHDPimicotinib 20236PimicotinibcGvHDII 20237PimicotinibIII Irpagratinib (ABSK011) 20237IrpagratinibIIIrpagratinib 202310Irpagratinib2023(ESMO)Phase 1b2022 ABSK012 20234FGFR4ABSK012FDA ABSK121 20232ABSK121I ABSK112 20237ABSK112FDANSCLCI ABSK043 20237ABSK043PD-L1I202310ESMO 20233 •ABK3376EGFR-TKI••187.903 IND ABSK051CD73 EGFR20EGFR 20236302,102.4291.0202212312,258.8156.4 2022630202363019.1 202263011.726.0202363037.7 2022630159.045.62023630204.6 202263055.810.1202363045.7 20226301.40.220236301.2 202263017.13.3202363013.8 2022630221.613.02023630208.6 2022630124.464.62023630189.0 202263032.92.8202363035.7 2022630164.018.92023630182.91)2)3)4 I 201615 152023630 ALS =cGvHD =FGFRalt =HCC =NSCLC =RMS =TGCT =TNBC =UC =WHIM= (i)Ib/II(ii)F.Hoffmann-La Roche Ltd.PD-L1(iii)PD-1(iv)PD-1(v) Pimicotinib (ABSK021) PimicotinibCSF-1RCSF-1CSF-1RTGCTcGvHDALS TGCTPimicotinibIII1005030PimicotinibFDABTDEMAPRIMETGCT 20231PimicotinibcGvHDIIPimicotinibCSF-1R 20231PimicotinibFDABTDTGCTBTDPimicotinibIb 20233PimicotinibFDATGCTIII 20234PimicotinibIIIPimicotinibTGCT 202352023ASCOPimicotinibTGCTIbPimicotinibTGCTPoster Bd#:493EFFICACY AND SAFETY PROFILE OF PIMICOTINIB (ABSK021) IN TENOSYNOVIALGIANT CELL TUMOR (TGCT): PHASE 1B UPDATEPimicotinib50mgORR77.4%RECIST1.1Pimicotinib89.8%50mg9.312.5 20236PimicotinibEMAPRIMETGCTPRIMEPimicotinibIbPRIMEBTD 20236PimicotinibcGvHDII ABSK021 Irpagratinib (ABSK011) I r p a g r a t i n i bF G F R 4IrpagratinibFGF19/FGFR4HCCFGFR4HCCFGF19/FGFR4HCC30%FGFR4 FGF19HCCIb180mgIaIrpagratinibPK/PD320mg160mg IrpagratinibPD-L1FGF19HCCII20221 IrpagratinibFGF19HCCIFGF19+FGF1922%ORR(4/18)160mgFGF19 IHC+ORR33.3% (2/6)Irpagratinib67%FGF19 IHC+ HCCFGF194 20237IrpagratinibIIIrpagratinib ABSK011 Fexagratinib (ABSK091AZD4547) FexagratinibAZD4547FGFR123FGFR(32%)(25%)(18%)(11%)(7%)FGFRFGFR1FGFR2FGFR3 FexagratinibFGFRFexagratinibAstraZeneca AB2009Fexagratinib (AZD4547)200920194III201911Fexagratinib BISCAYFexagratinib31.3%FGFR2/3FGFR(ORR)32.2% FGFR33%FGFR2FexagratinibFexagratinibFGFR FGFR2/3Fexagratinib II202111 2022FexagratinibFGFR2FGFR3II FGFR3mUCORR30.7%(4/13)FGFR3ORR44% (4/9)FexagratinibBISCAYFexagratinib 80mg4 FexagratinibII ABSK091 ABSK043 ABSK043PD-L1PD-1PD-L1ABSK043PD-1/PD-L1PD-L1TABSK043 ABSK043PK/PDI 2022ABSK043IIND20229(ABSK043-101)ABSK043 ABSK043 ABSK061 ABSK061FGFR2/3ABSK061FGFR2/3FGFR1FGFR2/3FGFR1FGFRABSK061FGFR ABSK061IINDABSK061I ABSK061 ABSK121 ABSK121FGFRFGFR1-3FGFR1-3FGFRFGFRFGFRABSK121FGFR1-3FGFRFGFR 20232ABSK121I ABSK121 ABSK112 ABSK112EGFR20EGFR3%5%NSCLCEGFR20EGFREGFRABSK112EGFR20EGFREGFR20PD 20237ABSK112FDANSCLCI ABSK112 ABSK081 ABSK081 (mavorixafor)X4P-001CXCR4CXCR4ABSK081CXCR4CXCL12(TME)20197X4ABSK081(mavorixafor)WHIMmozobilHSCTHSCT ABSK081(mavorixafor)TNBCIb/II20217 ABSK081 ABSK051CD73CD73 ABSK012FGFR4FGFR4ABSK012FGFR4FGFR4FGFR4FGF19FGFR4 20233ABK3376EGFR-TKI187.90 202363019971%23%82%35% AmeileCymbaltaBalversaReyvowFu LaimeiKisqaliXinfuVenclexta 25 20INDPimicotinib IIIABSK043 IABSK061 IIrpagratinib IbFexagratinib II 2023630 PimicotinibTGCTIII Irpagratinib202310ESMOPhase 1b2022 ABSK043202310ESMO II 2022630202363019.1 202263011.726.0202363037.71)20.824.3 2022630159.045.62023630204.638.8 202263055.810.1202363045.711.0 20226301.40.220236301.22023630 202263017.13.3202363013.8 2023630 2023630252 20236302,102.4291.0202212312,258.8156.4 20236302,266.62,102.4164.2202363085.375.110.2 100%20236304.93%202212315.75% 2023630 20236302022630 20236302023630 2023630 2023630 2023630 13.51B(1)2022123113.51(2)(a)(e)(g) 2023619 13.51B(1) C.2.1 202110131,674 20219302023630 2023630XV(a)XV78(b)352(c) (1)118,116,676 2021526(i)2016(ii)(iii) YaochangFamily Holding LimitedHery International Development LimitedHery InternationalDevelopment LimitedYaochang Family Holding Limited70,290,520(2)10,880,054 Zabuye TrustChogirLimitedZabuye LimitedZabuye TrustJamdrokLimitedZabuye TrustZabuye LimitedChogir Limited4,948,690(2)Jamdrok Limited4,948,680(3)8,575,