劲方医药-B2025 年中期报告

勁方醫藥科技 ( 上海 ) 股份有限公司G e nF l eet Therapeut i cs ( S ha n gh ai ) I nc . 股份代號：2595（於中華人民共和國註冊成立的股份有限公司） 中期報告2025 2 4 21 25 26 27 29 30 32 50 53 12068234 5 18346 H 183171712-1716 18127 97927 Davis Polk & Wardwell3A10 2595 genfleet.com 81 8821 CMC RASGFH925fulzerasib®NSCLCGFH375KRASG12DRASGFH312711128PCT12592PCT = NSCLCPADADCCRCICPDACAMLPBC (1)GFH925/cetuximabcetuximabcetuximabcetuximab2004EGFRRASCRCcetuximab20062004 (2)GFH925/cetuximabIbIIGFH925/cetuximabIII20252INDFDAINDEMAGFH925/cetuximabIII (3)V e r a s t e mG F H37520251VerastemGFH375 GFH009 (5)GFH018 (6)GFH312I20227FDAINDIGFH312PADICIIIFDA20228IND RAS (1)GFH925NSCLCCRCKRAS G12C G F H925f u l z e r a s i b®K R A SG12CKRASG12CKRASG12CKRASNSCLCKRAS40%GFH925KRAS G12C(i)20248NDANSCLC(ii)20257KRAS G12CNSCLC GFH925GFH92520217INDGFH9252023120235BTDKRASG12CNSCLCCRC20248GFH925NSCLCNDAKRASNDAIIGFH925KRASG12CNSCLC G F H925E M AcetuximabEGFRNSCLCIb/IIIb/IIGFH925cetuximab2024ASCO33ORR81.8%DCR100%GFH925/cetuximabNSCLC(70.0%) GFH925Ib/IIII2025ELCC453331100%57.8%50%ORR80%DCR100%34%RECIST1.1 ORR71.4%5 2025IIIIIGFH925/cetuximab NSCLCGFH925CRCGFH925KRASG12CCRCFDA20244GFH925CRCIIIIND NSCLCCRCGFH925KRASG12CNSCLCCRCGFH925 18A.08(3)GFH925fulzerasib® (2)GFH375KRAS G12D G F H375K R A SG12DGTPGDPGFH375KRAS G12D KRASG12DKRAS35%12%CRC4%NSCLCKRASG12DKRAS G12CKRAS G12DGTPKRAS G12DKRAS G12D G F H 3 7 5K R A SG12DGFH375GFH375PDACNSCLCGFH375KRASG12DGFH375 GFH375I/IIKRASG12D20246IND20252IIGFH375 IIPDAC20259GFH375cetuximabgemcitabineAGIb/II GFH37520262028GFH375 18A.08(3)GFH375 RASRAS RASGFH925GFH375CMCRASKRASG12DRASRASRASRASRASGFH276GFS784RASRASRAS (1)GFH276RAS GFH276RASACypARASRASGFH276CypARASRAS GFH276RASsotorasibadagrasibKRASG12CGFH276RTKKRASG12CIIIRASRMC-6236GFH276GFH276RAS 20256GFH276I/IIIND20259IND 18A.08(3)GFH276 (2)GFS784 GFS784FASconEGFRRASRASGFS784GFH925/cetuximabRASDxdADCGFS784 18A.08(3)GFS784 RAS RASGFH312RIPK1GFS202AGDF15IL-6 (1)GFH312RIPK1 GFH312RIPK1PADICPBCGFH312RIPK1GFH312 RIPK1IIPADICPBCRIPK1 GFH312IIFDAGFH312PADICIIIIGFH312PADICGFH312PBC20255PBCGFH312II2026 18A.08(3)GFH312 (2)GFS202A GFS202AGDF15IL-6 50%FDAGDF15IL-6GDF15GFS202A1.54mg/kgGFS202A 202412IND20253IND20254GFS202AI 18A.08(3)GFS202A (1) CMC • • • GFH018TGF-βR1GFH009CDK9 (2)CMC CMCCMCCMCGMPNDACMC •CMCCMCGFH925CMCGFH925INDCMCRAS •CMCGFH92530GFH925CMCGFH925 (3) GFH925SELLASGFH009AMLCDK9VerastemRASRAScetuximabGFH925cetuximabNSCLC (1) GFH925GFH375GFH312 (2)RAS RASRAS RASIND GFH009GFH018 (3) (4)GMP CMCCMOCDMOGMP (5) KRASG12CG12DKRASNSCLCCRC KRASG12CGFH925KRAS G12DGFH375KRASNSCLCCRCGFH92520248NSCLCGFH925/cetuximabNSCLCCRCIIGFH37520246INDNSCLC/PDACI/IIRASRASRASRASGFH276GFS784RASGFH312GFS202A GMP 202563088.742024630 202563016.922024630 20256308.18202463011.2727.41% 2024630186.002025630122.4420246302025630 202563036.95202463018.5199.64% 202463032025630292 202463014.6020256303.03 2025630615.872024630241.46 2025630698.602024630449.30 20256302025202463050.49162.96GFH925GFH925 2025630346.5320241231362.13 202563079.0020256302.30%2.75% 2 0 2 563 05 7 8 . 6 2 %2 0 2 41 23 1422.38% 2025630 2025630 2025630 5% 94 2026202563049.76202463059.78 H20256302 H2025630 20256302025630 3.212D.3 3.10(2)3.21 2025630 2410 H20259191,669.92 2025630 2025630XV783522025630XV 2025630XV233362025630 202020237H17 2025919H2025919H20.3989,240,0000.10H1,669.92 2025630 264920256303434 2410 34 2025917 1. 2017823120682345 2. 202563034 2. 202563020256302,607,347,0002,829,994,00020241226(i)(ii)(iii)(iv)2025630 20252025630 3. 3. (a) (b) 8 4. (b) GFH925 202191G F H925GFH925(i)GFH925(ii)GFH925 4. (b) GFH925 20241GFH92520,000,000GFH92520256302,000,00014,165,00018,000,0002026121 GFH375 2 0 2 38V S T MVerastem,Inc.VerastemVerastemVerastem VerastemVerastemVerastemVerastem20251Verastem 5. 6. 7. 8. 9. 2025202463025% 20222025202463015% 2022[2022]132 0 2 2112 0 2 71 23 11,000,0003,000,00025%20%2025202463020% [2018]76 2025202463050,000,00025%2025630202520246302024630 2025202463021%2025630202520246302024630 9. 10. 20256302024630 11. 3060 920252024630 17. 202412312025630 17. 18. 202472526,774,0631.02024929 (a)202372424,852,00025,100,0002023122825,100,00026,774,000 (b)202433,073,00012,860,0002024123126,774,000 19. 20. (a) ** (b) (c) 21. 2025630 22. 2025917 H0.10 2025925 2025919H 0.10H TGA 0.10 % RDERIPKRTKTGF-β-βTGF-βR-β