和誉-B2023年度报告

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） 年度報告2023 24691432377592979899101103166 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 20231231 •PimicotinibTGCTCSF-1RPimicotinibNMPAFDABTDEMAPRIMETGCTFDAFTDEMAODDTGCTIbpimicotinibORR87.5% •PimicotinibcGvHD •IrpagratinibFGFR4HCCIb/II2023(ESMO)ORR40.7%POCHCCIrpagratinibatezolizumab •PD-L1 ABSK043FGFR2/3ABSK061FGFRABSK121ABSK0432023ESMOORR27%) •INDNMPAABSK051FDAABSK012NMPAFDAABSK112 •PCCEGFR-C797SABK3376PRMT5*MTAABSK131 •20233ABK3376ABK3376NSCLCEGFR•202312Merck KGaA, Darmstadt, GermanyMerckpimicotinibTGCTcGvHD CSF-1R • • 2024312 202312311,971.5202212312,258.8287.3 202212312023123119.12023 2022123145.641.82023123187.4 20221231378.755.020231231433.7 20221231118.422.02023123196.427.8 2022123141.335.6202312315.7 202212312.690.52202312312.17 20221231495.620231231431.6 20221231313.692.320231231405.9 2022123173.43.42023123176.8 20221231385.51.320231231384.2123 20232024312 Pimicotinib (ABSK021) •pimicotinibTGCTIIIPimicotinibFDA(BTD)(EMA)(PRIME)TGCTFDAFTDTGCT •20237ABSK021TGCTIII20234pimicotinib •20239EMApimicotinibTGCTIIIpimicotinibIIIIIICSF-1R •2023112023CTOSpimicotinib2022CTOS6pimicotinibTGCTIRCRECIST 1.1ORR50mg(QD)25mg QD87.5%66.7%pimicotinibpimicotinib12.217.583.9% •202311ABSK021IIpimicotinibTGCTcGvHD •202312pimicotinibFDAFTDTGCT •20241pimicotinibEMAODDTGCTEMAODD Irpagratinib (ABSK011) •FGF19HCCirpagratinibF. Hoffmann-La Roche Ltd.PD-L1II •20237NMPACDEirpagratinibIIirpagratinib •20239CDEirpagratinibHCCirpagratinibHCC •20239FDAirpagratinibINDABSK-0111irpagratinib •202310ESMOirpagratinibFGF19HCCIbHCCirpagratinibirpagratinib(BID)FGF19HCCORR40.7%BID Fexagratinib (ABSK091AZD4547) •fexagratinibFGFR2/3II202111 •2022fexagratinibFGFR2FGFR3II •F G F R3m U CO R R30.7%(4/13)FGFR3ORR44% (4/9)fexagratinibBISCAYfexagratinib 80mg4 •fexagratinibII ABSK043 •IPD-L1ABSK043PK/PD •2023102023ESMOABSK043ABSK0431,000mg(DLT) ABSK061 •ABSK061IABSK061FGFR2/3 •202422024ESMO TATABSK061ABSK061 75mg BID150mg QD8FGFRORR37.5% ABSK121 •ABSK121FGFRFGFR1-3FGFR1-3 •20236I ABSK112 •20231020237EGFR Exon20insABSK112NMPAFDAI •20242NSCLC ABSK051 •ICD73ABSK051PK/PD•202311NMPAABSK051IIND•20241I ABSK012 •ABSK012FGFR4FGFR4 •20234ABSK012FDAODDSTS•202311FDAABSK012IIND •ABK3376EGFREGFR-TKIC797S •ABSK131MTAPRMT5PRMT5*MTAABSK13135EORTCPRMT5*MTA •20233•ABK3376EGFR-TKI••20233187.90 Merck •202312MerckMerckpimicotinibMerckpimicotinib •2024270•MerckMerck605.5(%) I. 201616 1620231231 cGvHD =FGFRalt =HCC =NSCLC =RMS =TGCT =TNBC =UC=WHIM = Pimicotinib (ABSK021) PimicotinibCSF-1RCSF-1CSF-1RTGCTcGvHDALS pimicotinibTGCTIIIPimicotinibFDA(BTD)(EMA)(PRIME)TGCTFDAFTDTGCT 20231pimicotinibcGvHDIIpimicotinibCSF-1R 20231pimicotinibFDABTDTGCTBTDpimicotinibTGCTIb 20233pimicotinibFDATGCTIII 20234pimicotinibIIIpimicotinibTGCT 202352023ASCOpimicotinibTGCTIbpimicotinibTGCTEFFICACY AND SAFETY PROFILE OF PIMICOTINIB (ABSK021) IN TENOSYNOVIAL GIANTCELL TUMOR (TGCT): PHASE 1B UPDATEPimicotinib50mgORR77.4%RECIST 1.1Pimicotinib89.8%50mg9.312.5 20236pimicotinibEMAPRIMETGCTPRIMEpimicotinibIbPRIMEBTD 20236pimicotinibcGvHDII 20237ABSK021TGCTIII 20239EMApimicotinibTGCTIIIpimicotinibIIIIIICSF-1R 2023112023CTOSpimicotinibTGCTpimicotinibIIIIb2022CTOS6pimicotinibTGCTIRCRECIST 1.1ORR50mg QD25mg QD 87.5%66.7%pimicotinibpimicotinib12.217.583.9% 202311ABSK021ABSK021IIpimicotinibTGCTcGvHD 202312pimicotinibFDAFTDTGCTFDAFDAFDA 20241pimicotinibEMAODDTGCTEMA ABSK021 Irpagratinib (ABSK011) I r p a g r a t i n i bF G F R 4IrpagratinibFGF19/FGFR4FGFR4HCCFGF19/FGFR4HCC30%FGFR4 FGF19HCCirpagratinibPD-L1II 20237NMPACDEirpagratinibIIirpagratinib 20239irpagratinibHCCirpagratinibHCC 20239FDAirpagratinibINDABSK011Iirpagratinib 2023102023ESMOirpagratinibFGF19HCCIbHCCirpagratinibirpagratinibBIDFGF19HCCORR40.7%BID ABSK011 Fexagratinib (ABSK091, AZD4547) FexagratinibAZD4547FGFR123FGFR(32%)(25%)(18%)(11%)(7%)FGFRFGFR1FGFR2FGFR3 FexagratinibFGFRfexagratinibAstraZeneca AB2009fexagratinib (AZD4547)20092019III201911fexagratinib BISCAYfexagratinib31.3%FGFR2/3FGFRORR32.2% FGFR33%FGFR2fexagratinibfexagratinibFGFR FGFR2/3fexagratinib II 2022fexagratinibFGFR2FGFR3II FGFR3mUCORR30.7%(4/13)FGFR3ORR44%(4/9)fexagratinibBISCAYfexagratinib 80mg4 fexagratinibII ABSK091 ABSK043 ABSK043PD-L1PD-1PD-L1ABSK043PD-1/PD-L1PD-L1TABSK043 IABSK043PK/PD 20229 2023102023ESMOABSK043ABSK0431,000mg ABSK043 ABSK061 ABSK061FGFR2/3ABSK061FGFR2/3FGFR1FGFR2/3FGFR1FGFRABSK061FGFR ABSK061I 202422024ESMO TATABSK061ABSK061 75mg BID150mg QD8FGFRORR37.5% ABSK061 ABSK121 ABSK121FGFRFGFR1-3FGFR1-3FGFRFGFRFGFRABSK121FGFR1-3FGFRFGFR 20236I ABSK121 ABSK112 ABSK112EGFR Exon20insEGFR3%5%NSCLCEGFR20EGFREGFRABSK112EGFR20EGFREGFR20PD 20231020237