劲方医药-B2025 年年度报告

（於中華人民共和國註冊成立的股份有限公司） 股份代號: 2595 2025Annual Report年度報告 24526315270136141142144145147211212217 20263242026324 20263242026324 12068234 5 18346 H 183171712-1716 18127 97927 Davis Polk & Wardwell3A10 2595 www.genfleet.com 81 8821 RASKRAS G12C2026GFH375IIIKRASG12DGFH276Pan RASGFS202AKRAS+EGFRKROCUS Biotech GFH375ON-and-OFFGFS202AGDF15IL-6EGFRRASKROCUSII RAS KRASG12C20242025RAS 2025GFH375KRASG12DIIIGFH375(NSCLC)(LBA)KRAS+EGFRNSCLCIILBAGDF15/IL-6GFS202APan RASGFH276 20251.325%2025202025202218A2.681118A GFH375KRAS G12D GFH375KRASG12D202511KRASG12DIIIKRASG12DGFH37520262NSCLCKRASG12DGFH375(PDAC)NSCLCI/II2025(ASCO)(WCLC)(ESMO)PDACNSCLC GFH375Ib/IIGFH375PDACGFH375EGFRPDAC(CRC)GFH375 G F H375V e r a s t e m20251G F H375/VS-7375GFH375Verastem2023GFH375/VS-7375GFH375VerastemVS-737520257VS-7375FDAKRASG12DPDACFDAVerastemIIVS-7375(2L PDAC)(2L/3L NSCLC)(cetuximab)(2L+ CRC) LBA 2025WCLCESMO(ELCC)ASCO(AACR) •WCLCGFH375NSCLCI/II20259WCLCLBA202571526NSCLCORR57.7%DCR88.5%600mg QD(RP2D)ORR68.8%DCR93.8% •ESMOGFH375PDACI/II202510ESMOLBA202592759600 mg QD(RP2D)ORR40.7%DCR96.7%•ELCCKROCUSKRAS G12CEGFRII20253ELCCLBA202511445(ORR)80%(DCR)100%(mPFS)12.5•ASCOGFH375KRASG12DI20256ASCO•AACRGFH276RASGFS202AGDF15/IL-620254AACR +RAS RASRASRASswitchII pocketRAS RASKRAS G12CIIIKRASG12DGFH375PanRASGFH276PanRASADCGFS784GFH375GFH375PDACRASKROCUSKRAS+EGFRNSCLC RASRAS •RAS+510%KRASKRASKRASG12D60%RAS •KRAS+EGFRNSCLC80%RAS30%KRASNSCLC(SOC)NSCLCKRASG12CKROCUSKRAS+EGFRNSCLCKRASSOC •FDANMPAGFS202AGDF15/IL-6I50%30% •STAT6PROTACJAKIL-4RIL-13PROTACGFH946 2017 (1)GFH925/cetuximabcetuximabcetuximabcetuximab2004EGFRRASCRCcetuximab20062004 (2)V e r a s t e mG F H37520251VerastemGFH375 (3)SELLASGFH009 (4)GFH312I20227FDAINDIGFH312PADICIIIFDA20228IND 1.GFH375KRAS G12D G F H375K R A SG12DGTPGDPGFH37520246I/II202511KRASG12DIIIKRASG12DGFH37520262NSCLCKRASG12D20257FDAKRAS G12DPDAC KRASG12DKRAS35%12%CRC4%NSCLCKRASG12DKRAS G12CKRAS G12DGTPKRAS G12DKRAS G12D GFH375KRASG12DGFH375GFH375PDACNSCLCGFH375KRASG12DGFH375 GFH375KRAS G12DPDAC2025ESMOLBAII600 mgQD(RP2D)PDAC2025927I/II66PDACGFH3752025927495.5%IV(78.8%)(28.8%)(28.8%)68.2%1/359ORR40.7%DCR96.7%91.5%5.65(mPFS)5.524(PFSrate)78.2%2025927(OS)4(OS rate)92.2% 2025827RP2DPDAC(TRAE)TRAE1-23TRAE31.8%14TRAE5TRAE GFH375KRASG12DNSCLC2025WCLCLBAI/IIN S C L C202571528N S C L C(42.9%)(17.9%)(10.7%)61296.4%22PD-L149%59.1%1%NSCLC15.16.326NSCLCORR57.7%DCR88.5%15600mgQD(RP2D)ORR68.8%DCR93.8% GFH3752025617NSCLC(TRAE)1-2TRAE3/4TRAE(6.3%)(4.2%) 18A.08(3)GFH375 2.GFH276RAS GFH276ACypARASRASGFH276CypARASRAS GFH276RASsotorasibadagrasibKRASG12CGFH276RTKKRASG12CIIIRASRMC-6236GFH276GFH276RAS GFH276GFH276Pan RAS (ON)20259GFH276(CypA-GFH276-RAS)RASGFH27620259I/IIRAS3TRAE 2025AACRKRASG12CG12D G12VG13D2-3GFH2760.3-3mg/kg QDRMC-623610 mg/kg QDGFH27613 mg/kg QDGFH276 KRASSIIPKRASEGFRTKGFH276ERK1/2GFH276 18A.08(3)GFH276 3.GFH925KRAS G12C GFH925fulzerasib®KRASG12CKRASG12CKRASG12CKRASNSCLCKRAS40%GFH925KRASG12C(i)20248NSCLC(ii)20256KRASG12CNSCLC(iii)2025122026 G F H 9 2 5E M Ac e t u x i m a bE G F RN S C L CI b / I IKROCUSKRAS+EGFRNSCLCIb/IIGFH925cetuximabNSCLCKROCUSKRAS NSCLC2025ELCCLBAII202511447KRASG12CKROCUS600mgBID500mg/m2 Q2W202511445ORR80%DCR100%16(34%)14RECIST1.1ORR71.4%(mDoR)2410.1mPFS12.5(mOS) 202511487.2%TRAE1-214.9%3TRAE45TRAE23TRAEG12CNSCLCKROCUSTRAE 18A.08(3)GFH925fulzerasib® 4.GFS202A GFS202AGDF15IL-6 50%30% GDF15ponsegromabGDF15GDF15ponsegromabvisugromabIL-6R(tocilizumab)FDAGDF15IL-6GDF15 GFS202AGFS202A20253IGDF15C 2025AACRGFS202AGFS202AGDF15IL-6GDF15IL-6GDF15/GFRAL/RETIL-6/IL-6R/gp130GFS202AGFS202ACGFS202AponsegromabGDF-15GFS202ACGDF15GFS202APK 18A.08(3)GFS202A 5.GFS784 GFS784PanRAS ADCGFS784FASconEGFREGFRRASPanRAS(ON)GFS784GFH925/cetuximab GFS784RASEGFRGFS784GFS784DXdADC+RMC-6236GFS784CDXGFS7842026AACR 18A.08(3)GFS784 6.GFH946STAT6 PROTAC GFH946STAT6PROTACIL-4/IL-13STAT6IL-4Th2IgESTAT6GFH946STAT61.4 GFH946GFH946STAT6KT-621STAT6(PBMC)GFH946DC₅₀KT-621PBMCGFH946IL-4(TARC)TARCIC₅₀KT-621P450CYPhERG 18A.08(3)GFH946 •RAS-ADCFASconFAScon(FunctionalAntibody Synergistic conjugate)RASRAS ••ADC•TPD 202557 202520222025ESG •RASRAS30%RAS2025-2032RAS400-500PanRASRMC-623620242.3(GlobalData)202570(RBC Captial Markets) KRASG12CRASRASDelveinsightKRASRAS203478(CAGR)35%G12DKRAS30%KRASG12DKRAS2032KRASG12D66 RASRASRASRAS+ •RAS+RAS90%KRAS G12D40%RASTP53CDKN2AKRASG12D203777CAGR2.6%ResearchNesterCAGR13.6%2037930 PanRASGFH375IIIGFH375NSCLC2027202820272-5GFH375 IP2020IIKRAS+EGFRNSCLCGFH009CDK92020GFH312RIPK120212022BD(ADC) 20251231130.2720241231104.70V e r a s t e mGFH375 2025123146.612024123120.10 2025123134.812024123128.5322%13.953.543.44 20241231332.1220251231282.262024GFH92545.402024GFH92528.77 2025123181.382024123158.0840.11% 2024123112025123123.9623.84 2024123117.96202512316.3911.84 202512311,518.8520241231382.6020259193,732.97 202512311,794.5320241231677.64 (i)(ii)(iii)202512311,518.92024382.620259192025123126.3202426.92025123122.9202418.4 202520241231 20251231