和誉-B2025 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） 2025中 期 報 告 2 4 7 9 36 69 70 71 72 74 76 20252282025228 202533202533 20252282025228 20252282025228 Abbisko Cayman LimitedP.O. Box 309Ugland HouseGrand CaymanKY1-1104Cayman Islands 20252282025228 8983 24840 Maples Fund Services (Cayman) LimitedPO Box 1093, Boundary HallCricket SquareGrand CaymanKY1-1102Cayman Islands 183171712-1716 •97914 5047518001 979127 2256 www.abbisko.com 2025630 2025 CSF-1R(ABSK021) TGCTNDANMPA •20256NMPATGCTNDANDAIIIMANEUVERBIRC25ORR54.0% vs.3.2%p<0.0001 •NDATGCTBICNMPA20255 85 •20254202558570155 FGFR4(ABSK011) HCC •20256ICImTKIFGF19HCC •BSCBSC21141ORR II •202572025ESMO-GIII220 mg BIDORR≥50%PFS≥7 NMPA •20255NMPACDEHCCBTDBTDHCC PD-L1ABSK043 I •202412ABSK043I49(600-1000mg BID)ABSK043ORR20.4%15NSCLCORR33.3%DCR 73.3%PD-L1(TPS≥50%)NSCLCEGFRKRASORR41.7% NSCLC+ •20253ABSK043KRAS-G12CKRAS-G12CNSCLC •ABSK043EGFR TKIEGFRNSCLCII FGFR2/3ABSK061 •ABSK061ABSK043PD-L1ABSK061ORR37.5%202411ABSK061ABSK043GC/GEJII ACH •20256NMPAINDACH •ABSK131PRMT5-MTA20252025AACRABSK131FDANMPA20241220253ABSK131IND20257ABSK131MTAPI •ABSK141KRAS-G12D •2025Pan-KRASPCCABSK211 20252025630657.1612.185.0328.5 202533200.020256309,545,0002025111.4%75.3202422,594,00068.7 20256302,331.7202412311,959.2372.5 •2025630612.1 •2024630215.112.92025630228.0 1 I. 20162212 22 cGvHD =COPD =FGFRalt =GC =HCC =NSCLC =RMS =TGCT =UC =WHIM = •CSF-1R(ABSK021) CSF-1RCSF-1CSF-1RTGCTcGvHDALS 202411NMPA2025520256NMPATGCTNDANMPAFDABTDEMAPRIMETGCTTGCTFDAFTDEMAODD cGvHDcGvHDHSCT TGCT 20255NMPA20256NDA NDA202411IIIMANEUVERBIRC25ORR(54.0% vs.3.2%p < 0.0001)TGCT202562025ASCO 2024112024CTOSTGCTIb202463050mg QD42IRCRECIST1.1ORR85.0%20.67(0.5, 30.1) cGvHD 20241266ASHcGvHDII2024112220mg QD64%ORRcGvHD1 ABSK021 •FGFR4(ABSK011) FGFR4FGF19/FGFR4HCCFGFR4HCCFGF19/FGFR4HCC30%FGFR4 HCCHCCHCC 20256(ABSK-011-205)BSCBSCICImTKIFGF19HCC21141ORR 202492024ESMOHCCI220mgBIDICImTKIFGF19+HCCORR44.8%mDoR 7.4PFS5.5 20255HCCNMPABTD20244FDAODD PD-L1FGF19HCCII 202572025ESMO-GIHCCII220 mg BIDORR≥50%PFS≥7 ABSK011 •PD-L1ABSK043 ABSK043PD-L1 PD-1PD-L1 ABSK043I ABSK043 IABSK043PK/PD Ib 2024122024ESMO Asia 2024ABSK043 I49(600-1000mg BID)ABSK043ORR20.4%15NSCLCORR33.3%DCR73.3%PD-L1(TPS≥50%)NSCLCEGFRKRASORR41.7%90ABSK043ILD8.9%3TRAE 202412ABSK043EGFRNSCLCIIABSK043 20253688578ABSK043KRAS-G12CKRAS-G12CNSCLC ABSK043 •FGFR2/3ABSK061 ABSK061FGFR2/3FGFR1ABSK061FGFRACHACHFGFR3ACH ABSK061FGFR2/3FGFRABSK061FGFR ABSK061 ABSK061I 202422024ESMO TATABSK061ABSK061 75mg BID150mg QDFGFRORR37.5% ABSK043 202411ABSK061ABSK043PD-L1GC/GEJII ABSK061ABSK043FGFR ACH 20256ACHACHACH ABSK061 •FGFRfexagratinib (ABSK091/AZD4547) FexagratinibAZD4547FGFR123201911AstraZeneca ABfexagratinibfexagratinib fexagratinibIIII 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 202542025AACRABSK112 20231020237ABSK112NMPAFDAINDI 20242NSCLC ABSK112 •PRMT5*MTAABK131 ABSK131PRMT5-MTA202410202542024EORTC-NCI-AACR2025AACRABSK131 20241220253FDANMPAIND20257ABSK131MTAPI ABSK131 •ABK3376 (AST2303)EGFR-C797S ABK3376 (AST2303)EGFRABK3376EGFR-TKIEGFR-C797S20235ABK3376 20254ABK3376(AST2303)20249NMPAABK3376 (AST2303)EGFR-C797SNSCLCI ABK3376 (AST2303) •FGFR4ABSK012 ABSK012FGFR4FGFR4FGFR4ABSK012FGFR4FGFR4FGFR4FGF19FGFR4 202311FDAIIND20234ABSK012FDAODD ABSK012 •CXCR4mavorixafor (ABSK081/X4P-001) Mavorixafor (ABSK081)CXCR4CXCR4ABSK081CXCR4/CXCL12TME 20197X4 PharmaceuticalsX4mavorixafor (ABSK081)WHIMmozobilHSCTHSCT 20244X4FDAXolremdi (mavorixafor)12WHIM ABSK081 •CD73ABSK051 ABSK051CD73ABSK051CD73 IPK/PD20241 ABSK051 • ABSK141: KRAS-G12D ABSK141KRAS-G12D2025AACRABSK141ABSK141KRAS-G12DABSK141 ABSK141 ABSK211: Pan-KRAS ABSK211Pan-KRAS2025ABSK211 ABSK211 • 202312CSF-1R 2024270 202542025585 6.055 • 20233EGFR TKIABK3376ABK3376 (AST2303)187.9 20249NMPAABK3376 (AST2303)IND 202563022672%20%82%28% AmeileCymbaltaBalversaReyvowFu LaimeiKisqaliXinfu CMC 25 202563037INDIIIABSK043IABSK061ABSK112ABSK121IIbfexagratinibIb/II 2025630 202572025ESMO-GIHCCII 20257ABSK131MTAPI 2025 (BIC/FIC) II. 20256 30 1. 20256303420241231 2. 20241231 21 21 3. (a)4 (b) 8 4. 2024630497.3114.82025630612.12025630612,119,000Merck Healthcare KGaA (b) 5. * 202463048.53.6202563044.95.00.31.7 6. 2024630215.112.92025630228.010.1 7. 202463040.34.9202563035.4 8. 20246304.11.020256303.1 9. 20246300.920256300.8 10. 2.08.25%16.5% 25%2022102022120251015% 30% 202563061,211,900 11. 20256302024630 12. 624,565,4872024630639,220,610 13. 202412312025630 202563020241231 15. *20256304.13%5.22%202412314.13%5.3% 16. 20241231 2025630 2025630278 20256302,331.7202412311,959.219.0% 100