和誉-B2024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2024 12471013404589108113114115116118 20252282025228 202533202533 20252282025228 20241220 20252282025228 20252282025228 20244242024429 Abbisko Cayman LimitedP.O. Box 309Ugland HouseGrand CaymanKY1-1104Cayman Islands •97914 8983 5047518001 24840 Maples Fund Services (Cayman) LimitedPO Box 1093, Boundary HallCricket SquareGrand CaymanKY1-1102Cayman Islands 979127 183171712-1716 2256 www.abbisko.com 20241231 2024 2024III •PimicotinibABSK021 CSF-1R –202411pimicotinibTGCTIIIORR54%PimicotinibCSF-1RBIC –2024pimicotinibcGvHDIIpimicotinibORR64% •IrpagratinibABSK011 FGFR4 –irpagratinibHCCPOCIrpagratinibFGF19+ HCCORR44.8%atezolizumabFGF19+ HCCORR50%ICIsirpagratinibORRPFSirpagratinib –2024FGF19+ HCCCDE •ABSK043PD-L1 –IABSK043ORR20.4%PD-L1NSCLCEGFRKRASABSK0433TRAEILD –ABSK043PD-L1ABSK043 •ABSK061FGFR2/3 –ABSK061ORR37.5%ABSK061–ABSK061FGFRABSK061ACH 2024INDABSK131FDAABSK043ABSK061NMPAABSK043NMPAABK3376 (AST2303)NMPA 202412NMPAABSK131ABSK061ACHIND ABSK141 2024Merck Healthcare KGaAMerck 68.7 12311,959.2 2025 •p i m i c o t i n i bT G C TN D AirpagratinibHCC •• 202533 20241231504.0497.370.0Merck6.71.028.3 2024313100.02024123122,594,0002024113.22%68.7 202412311,959.2202312311,971.512.3 •20241231504.0Merck •20231231433.717.720241231451.4 1 2024202533 CSF-1RPIMICOTINIB (ABSK021) TGCTIII •202411pimicotinibTGCTIIIMANEUVERpimicotinibBIRCRECIST 1.125ORR54.0%(p<0.0001)3.2%pimicotinibpimicotinib TGCTIb •2024112024CTOSpimicotinibTGCTIb202463050mgpimicotinib42IRCRECIST 1.1ORR85.0%20.67(0.5, 30.1) cGvHDII •20241266ASHpimicotinibcGvHDIIpimicotinib 20mg QDORR64%pimicotinibcGvHD1 FGFR4irpagratinib (ABSK011) CDEHCC •202412CDEirpagratinibFGF19HCC •202492024ESMOirpagratinibIIrpagratinib 220mg BIDICIsmTKIsFGF19+HCCORR44.8%mPFS5.5mDoR7.4 •202462024ESMO-GIirpagratinibatezolizumabIIIrpagratinib 220mg BIDatezolizumabFGF19+HCCORR50% PD-L1ABSK043 I •2024122024ESMO Asia 2024ABSK043 I49(600-1000mgBID)ABSK043ORR20.4%15NSCLCORR33.3%DCR 73.3%PD-L1(TPS≥50%)NSCLCEGFRKRASORR41.7%90ABSK043ILD8.9%3TRAE NSCLCII+PD-L1+EGFR •202412ABSK043EGFR TKIEGFRNSCLCII FGFR2/3ABSK061 •202422024ESMO TATABSK061ABSK061 75mg BID150mg QD8FGFRORR37.5% II •202411ABSK061ABSK043PD-L1II ACHIND •202412NMPAABSK061ACHIND ABK3376ABSK131IND •ABK3376 (AST2303)EGFR20249NMPAABK3376(AST2303)EGFR-C797SNSCLCI •ABSK131PRMT5-MTA202410EORTC-NCI-AACRABSK131202412ABSK131FDAIND202412NMPAIND ABSK141KRAS-G12D202410EORTC-NCI-AACRABSK141ABSK141KRAS-G12DABSK141 I. 20161912 1920241231 cGvHD =FGFRalt =HCC =NSCLC =RMS =TGCT =UC =WHIM = •CSF-1Rpimicotinib (ABSK021) PimicotinibCSF-1RCSF-1CSF-1RTGCTcGvHDALS PimicotinibTGCTIIIMANEUVERCSF-1R202411MANEUVERPimicotinibNMPAFDABTDEMAPRIMETGCTpimicotinibTGCTFDAFTDEMAODD cGvHDcGvHDHSCTcGvHDIIpimicotinibcGvHD pimicotinibII TGCT 20244pimicotinibTGCTIIIMANEUVER949030IIITGCT III 202411pimicotinibTGCTIIIMANEUVERpimicotinibBIRCRECIST 1.125ORR54.0%(p<0.0001)3.2%pimicotinibORRpimicotinib 2024112024CTOSpimicotinibTGCTIb202463050mg QDpimicotinib42IRCRECIST1.1ORR85.0%20.67(0.5, 30.1)pimicotinib 2024112024AcoPpimicotinibTGCT50mg QDpimicotinibTGCT cGvHD 20241266ASHpimicotinibcGvHDII20241122pimicotinib 20mg QD64%ORR6pimicotinibpimicotinibcGvHD1 ABSK021 •FGFR4irpagratinib (ABSK011) IrpagratinibFGFR4FGF19/FGFR4HCCFGFR4HCCFGF19/FGFR4HCC30%FGFR4 irpagratinibHCCirpagratinibHCC Irpagratinib 202412NMPACDEirpagratinibirpagratinibBSCBSCFGF19HCC 202492024ESMOirpagratinibHCCIIrpagratinib 220mg BIDICImTKIsFGF19+HCCORR44.8%mDoR 7.4mPFS5.5 20244irpagratinibHCCFDAODD atezolizumab irpagratinibPD-L1atezolizumabFGF19HCCII 202462024ESMO-GIirpagratinibatezolizumabHCCIIIrpagratinib 220mg BIDatezolizumabFGF19+ HCCORR50%BID 202442024AACRirpagratinibirpagratinibHCC ABSK011 •PD-L1ABSK043 ABSK043PD-L1 PD-1PD-L1 ABSK043I ABSK043 IABSK043PK/PD Ib 202412ESMO Asia 2024ABSK043 I49(600-1000mg BID)ABSK043ORR20.4%15NSCLCORR33.3%DCR73.3%PD-L1(TPS≥50%)NSCLCEGFRKRASORR41.7%90ABSK043ILD8.9%3TRAE 202412ABSK043EGFRNSCLCIIABSK043 ABSK043 •FGFR2/3ABSK061 ABSK061FGFR2/3FGFR1ABSK061FGFRACHACHFGFR3 ABSK061FGFR2/3FGFRABSK061FGFR ABSK061I 202422024ESMO TATABSK061ABSK061 75mg BID150mg QDFGFRORR37.5% ABSK043 202411ABSK061ABSK043PD-L1II ABSK061ABSK043FGFR ACH 202412NMPAACHIND ABSK061 •FGFRfexagratinib (ABSK091/AZD4547) FexagratinibAZD4547FGFR123201911AstraZeneca ABfexagratinibfexagratinib fexagratinibIItislelizumabII 2022fexagratinibFGFR2FGFR3IIFexagratinibFGFR3mUCORR30.7%(4/13)FGFR3ORR44%(4/9)fexagratinibBISCAYfexagratinib 80mg BID4 ABSK091 •FGFR1-3ABSK121 ABSK121FGFRFGFR1-3FGFR1-3FGFRFGFRABSK121FGFRABSK121FGFR1-3FGFRFGFR I20236 ABSK121 •EGFR Exon20insABSK112 ABSK112EGFR Exon20insEGFR3%5%NSCLCEGFR20EGFRABSK112EGFR20EGFREGFR20PD 20231020237ABSK112NMPAFDAINDI 20242NSCLC ABSK112 •CXCR4mavorixafor (ABSK081/X4P-001) Mavorixafor (ABSK081)CXCR4CXCR4ABSK081CXCR4/CXCL12TME 20197X4 Pharmaceuticals, Inc.X4mavorixafor (ABSK081)WHIMmozob