和誉-B2024 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） 2 4 8 10 27 61 62 63 65 67 Abbisko Cayman LimitedP.O. Box 309Ugland HouseGrand CaymanKY1-1104Cayman Islands 8983 24840 20244242024429 Maples Fund Services (Cayman) LimitedPO Box 1093, Boundary HallCricket SquareGrand CaymanKY1-1102Cayman Islands 183171712-1716 Davis Polk & Wardwell3A10 5047518001 979127 2256 www.abbisko.com 2024630 2024 Pimicotinib (ABSK021) •pimicotinibTGCTIIIPimicotinibNMPAFDABTDEMAPRIMETGCTFDAFTDEMAODDTGCT •cGvHDIIII20236202311 •202312Merck Healthcare KGaAMerckMerckpimicotinibpimicotinib20242Merck70 •20241pimicotinibEMAODDTGCT •20243pimicotinibIIIMANEUVER (ABSK021-301)TGCT949030 Irpagratinib (ABSK011) •irpagratinibFGF19HCCIb •FGF19HCCirpagratinibF. Hoffmann-La Roche Ltd.PD-L1II•202310ESMOirpagratinibIbHCCirpagratinib(BID)FGF19+HCCORR40.7%•20244irpagratinibFDAODDHCC•202462024ESMO-GIirpagratinibHCCIIirpagratinib 220mg BIDFGF19+HCCORR50%BID Fexagratinib (ABSK091, AZD4547) •fexagratinibFGFR2/3II•2022fexagratinibFGFR2FGFR3II•FGFR3mUCORR30.7%(4/13)FGFR3ORR44% (4/9)fexagratinibBISCAYfexagratinib 80mgBID4•fexagratinibII ABSK043 •IABSK043PK/PD •Ib •2023102023ESMOABSK043ABSK0431,000mg11ABSK043ORR27.3%DLT •20245ABSK043688578®NSCLCIIABSK043INDCTA ABSK061 •ABSK061I•202422024ESMO TATABSK061ABSK061 75mg150mg8FGFRORR37.5%•ABSK061ACH20247NMPAIIIND ABSK121 •ABSK121I •20236 ABSK112 •20231020237EGFR Exon20insABSK112NMPAFDAI•20242NSCLC ABSK051 •IABSK051PK/PD •20241 ABSK012 •20234ABSK012FDAODD 202311FDAABSK012IIND •ABK3376(AST2303)EGFRABK3376EGFR-TKIEGFR-C797SIND •ABSK131PRMT5-MTAPRMT5*MTAABSK13135EORTCABSK131 Merck •202312MerckMerckpimicotinibMerckpimicotinib •2024270 •MerckMerck605.5(%) 2024630497.370Merck206.8 2024313100202463018,571,00056.320247315,833,0002.25%686,366,350 202312311,971.5151.020246302,122.5 202363019.1478.22024630497.3Merck 202363037.710.8202463048.5 2023630204.610.52024630215.1 202363045.75.4202463040.3 20236301.220246300.9 202363013.89.720246304.1 202463078.7 2024630206.82023630208.6415.4 2023630189.020.32024630209.3 202363035.71.7202463037.4 2023630182.9398.32024630215.4 I. 20161610 162024630 ALS =cGvHD =FGFRalt =HCC =NSCLC =RMS =TGCT =TNBC =UC =WHIM = F. Hoffmann-La Roche Ltd. Pimicotinib (ABSK021) PimicotinibCSF-1RCSF-1CSF-1RTGCTcGvHD pimicotinibTGCTIIIPimicotinibNMPAFDABTDEMAPRIMETGCTFDAFTDEMAODDTGCT pimicotinibcGvHDIIII20236202311 202312MerckMerckpimicotinibpimicotinibMerckpimicotinib20242Merck70 202312pimicotinibFDAFTDTGCTFTDFDAFTDFDAFDA 20241pimicotinibEMAODDTGCTEMAODD 20243pimicotinibIIIMANEUVER (ABSK021-301)TGCT949030IIITGCT IIINMPA202210FDA20233EMA20239III ABSK021 Irpagratinib (ABSK011) IrpagratinibFGFR4IrpagratinibFGF19/FGFR4HCCFGFR4HCCFGF19/FGFR4HCC30%FGFR4 irpagratinibFGF19HCCIb F G F 1 9H C Ci r p a g r a t i n i bP D - L 1atezolizumabII 202310ESMOirpagratinibIbirpagratinibHCCBIDFGF19+HCCORR40.7% 20244irpagratinibFDAODDHCC 202462024ESMO-GIirpagratinibatezolizumabHCCIIirpagratinib 220mg BIDatezolizumabFGF19+HCCORR50%BID ABSK011 Fexagratinib (ABSK091, AZD4547) FexagratinibAZD4547FGFR123FGFR(32%)(25%)(18%)(11%)(7%)FGFRFGFR1FGFR2FGFR3 FexagratinibFGFRfexagratinibAstraZeneca AB2009fexagratinib (AZD4547)20092019III201911fexagratinib BISCAYfexagratinib31.3%FGFR2/3FGFRORR32.2% FGFR33%FGFR2fexagratinibfexagratinibFGFR fexagratinibFGFR2/3II 2022fexagratinibFGFR2FGFR3II F G F R3m U CO R R30.7%(4/13)FGFR3ORR44%(4/9)fexagratinibBISCAYfexagratinib 80mg4 fexagratinibII ABSK091 ABSK043 ABSK043PD-L1PD-1PD-L1ABSK043PD-1/PD-L1PD-L1TABSK043 IABSK043PK/PD Ib 2023102023ESMOABSK043ABSK0431,000mg11ABSK043ORR27.3%DLT 20245®NSCLCABSK043IIABSK043INDCTA ABSK043 ABSK061 ABSK061FGFR2/3ABSK061FGFR2/3FGFR1FGFR2/3FGFR1 ACH80%ACHFGFR3 FGFRABSK061FGFR ABSK061I 202422024ESMO TATABSK061ABSK061 75mg150mg8FGFRORR37.5% ABSK061ACH20247NMPAIIIND ABSK061 ABSK121 ABSK121FGFRFGFR1-3FGFR1-3FGFRFGFRFGFRABSK121FGFR1-3FGFRFGFR I20236 ABSK121 ABSK112 ABSK112EGFR Exon20insEGFR3%5%NSCLCEGFR20EGFREGFRABSK112EGFR20EGFREGFR20PD 20231020237ABSK112NMPAFDAI 20242NSCLC ABSK112 ABSK081 ABSK081 (mavorixafor)X4P-001CXCR4CXCR4ABSK081CXCR4CXCL12(TME)20197X4 Pharmaceuticals, Inc.X4ABSK081 (mavorixafor)WHIMmozobilHSCTHSCT ABSK081 (mavorixafor)TNBCIb/II20217 ABSK081 ABSK051 ABSK051CD73CD73 IABSK051PK/PD202311NMPAABSK051IIND 20241 ABSK051 ABSK012 ABSK012FGFR4FGFR4ABSK012FGFR4FGFR4FGFR4FGF19FGFR4 20234ABSK012FDAODD 202311FDAABSK012IIND ABSK012 ABK3376 (AST2303)EGFRABK3376EGFR-TKIEGFR-C797SIND ABSK131PRMT5-MTAPRMT5*MTAABSK13135EORTCABSK131 202312MerckMerckpimicotinibMerckpimicotinib605.5(%) 20242Merck70MerckMerck 202463022170%21%81%29% AmeileCymbaltaBalversaReyvowFu LaimeiKisqaliXinfuVenclexta CMC 25 202463030INDpimicotinib IIIABSK043 IABSK061ABSK112 ABSK121 Iirpagratinib Ibfexagratinib Ib/II 2024630 202472202474700,0003.273.172,257,250 2024732024313202461715,833,00015,833,000686,366,350 20247ABSK061IINMPAIND II. 202363019.1478