华昊中天医药-B2025年报

（ 於中華人民共和國註冊成立的股份有限公司） 股份代號 : 2 5 6 3 2025年報 020305061030385671110115117119121123125126127129216217223 2002191916ADCIIIBIIICIV(NSCLC) 20212010- II/IIIADCADC Tang LiQiu Rongguo Tang Li 2025523 1222206 20255232025523 333304–3309 Tang Li Qiu Rongguo 223121202B Tang LiQiu Rongguo 2563 223121202B www.biostar-pharm.com 20241031 246802 H 1831717121716 2025 1(3ml;30mg)2025 2025 2025ADC 2025FDAIII(3ml;30mg) IIIII/IIIII/IIIII/IIIIII 2025 ADCADCADC2026 ADC HER2JAMAOncology2025(ASCO)(ESMO)(SABCS)100TOP10 20251231131.420241231143.812.48.6%202533.4202520247.173.2%2025202430.849.8% 20254PCTPCTPCTPCTPCTPCTPCT 2026++ 1 2 3BD 4 5 2026 1. 1920212010 IIIIIIIFDAIIIPFSORR325.1%2%4II/IIIIIIII/IIIII/III (ADC)+MMAETopoIADCTopoIADCP-gpADC2026IND-enabling HER2III HER290%AC2026HER2 PD-1II II(GC)(ESCC)CBR53%70%ORR20%40%PD-1PD-1GCESCCGC2723523ORR65.2%CBR100%mPFS6.1ESCC2018612ORR33.3%CBR100%2025ASCO HER2II2025JAMA Oncology202255202310254735CNS121–23CNS-ORR42.6%2024520(PFS)7.715.1 HER2II 2025ASCO34513109202412210.464.7%6CNS-ORR67.6%CNS-CBR88.2%CNS-PFS15PFS6TEAE1–22/363–4TEAE10% HER2II2025HER2202252025450TKIADCCNS-ORR54.0%CNS-DCR92.0%PFS8.695%CI7.0-10.2CNSCNS-PFS15.195%CI8.2-22.01–2HER2 IIII II120CNS-ORRMDMDAnderson Cancer Center·JohnHopkinsSidney Kimmel Comprehensive Cancer CenterCity of Hope-DuarteRobert H. Lurie Comprehensive Cancer Center Northwestern UniversityUniversity ofColoradoHospitalAugustaUniversityUniversityofCalifornia Los Angeles20 II IC502011(PR)3(SD)5(ORR)27.27%(DCR)72.72%(mOS)9.571–2FDA II 2025ESMO2025(STS)II202281920253327153(DDLPS)3242(7.4%)(PR)19(70.4%)(SD)ORR7.4%DCR77.8%PFS4.695%3.6–5.612OS80%(TRAEs)1–2TKISTSSTS NSCLCIII IIIII/III I 50mg/m2/5275mg/m2/575mg/m2/7321(DLT)3(AE)75mg/m2/72475mg/m2/5PopPK75mg/m2/dAUCAUC80%63PR13SDDoT2–13(TEAE)1/230mg/m260mg/m2(AUCinf)2974.82h*ng/mL1870.48h*ng/mL(F%)31.8% II I50100%86%84%≥ 242%≥ 396%HER272%HRHER224%42(84%)35(70%)CDK4/64427PR23PRORR52.3%DCR88.6%HER2ORR53.5%44PFS8.25DoR7.629(1–21)2025108162018ASCOORR 49.8%DCR 65.8%6325.1%2%312%29.6%4%5 II IIHER2395675.8%≥ 2287.9%75.8%3718PR15PRORR48.6%641≥3TRAE10%3 I PK25mg/m2/522150mg/m2/275mg/m2/6100mg/m2/3570mg/m2/2792DLT3415100mg/m2/1770mg/m2/(MTD)75mg/m/5111CR1PR7SD×2×2DoT12ORR18.2%CBR81.8%TEAE1/2≥20%2025ASCO II/IIIII78III700(OS)(PFS)ORRII/IIIINDFDACDEII/IIIII72III480II/IIIINDCDEIIII70IND202511FDAII35141CR8PR5SDORR64.3%DCR100%PFS7 III TNBC4403(IDFS)(OS) (ADC)+MMAETopoIADCTopoIADCP-gpADC (DAR)DARADC 2026IND-enabling 2. 3. PCTPCTPCT2041 PCTPCTPCT 4. — — II/IIIIIIII/IIIII/III —ADC ADCADCADC — ADC — cGMP — — 33.42024123171.953.6% 2.6202412319.773.2% 2024123162.150.5%2025123130.82025123192.2%2024123186.4% 202512311.1202412311.0 2024123161.949.8%2025123131.1 2024123152.334%2025123134.5 20241231116.328.6%2025123183 20241231-7.5177.7%202512315.8 202412310.11,990.0%202512312.9 2024123120251231 20241231143.812.320251231131.4 1.2.3. 20241231620.118%20251231508.6 20251231578456.87.23.658.945.56.22025123169.453.84.82.90.26.71.0 20251231491.820241231607.619.1% 20251231202512315% 20251231 20251231 202512311342025123153.12024123180.5 2020112021120221——D. 20251231 5,000,0002024202511202632,000,0003,000,0003,000,00021,086,400 2026412 3 2 23 2026330202632722026412 (i)2,000,0002026411(ii)3,000,000(a)2026414(b)2026413(c)2026416(d)2026416 2026 TangLi62200512020720213202312 2016220227Biostar Pharma, Inc.202411 401983(i)1983719858(ii)1985919887(iii)19888198912(iv)1990919941(v)1994219984(vi)19985200410Kosan Biosciences, Inc.(vii)20061220129 (i)19837(ii)198810(iii)199484040 Qiu Rongguo6420027202132020720027202312 2015120227Biostar Pharma, Inc. 40(i)19861219901(ii)1990219929(iii)199210199712OnyxPharmaceuticals,Inc.(iv)19981200010(v)200010200112Kosan Biosciences, Inc.(vi)2002120026Panomics, Inc.(vii)20061220129 1983719878199754015 5020188202132023122015620169 20199892003120155 19986201312 4220233202312 13(i)20091020107AustarPharma LLC(ii)2011820129(iii)201211201511(iv)20151120223 201520202016113201720182022333 2006720116 70202312 20151220221 (i)1983819888(ii)198810199461994619957(iii)19941199612(iv)199571997920069201512 19938 19837 4920255 200172004720048200612200712019620197 2024 20223 18(i)2007(ii)20181(iii)20161(iv)20167(v)20181 199171994619987200120065 5620255 1993200210 20251130Teamway International Group Holdings Limited1239202442515202268001GEM2025111320227202112202578613GEM2022420251683620251720221120236202312023938860550 6320255 CPACPA CPA 572016220213 (i)200111(ii)20138(iii)20146(iv)201411(v)20168(vi)20173(vii)20166(viii)201910(ix)201911 719997 402016122009102020820221 20096 492021320033201812 20028200321999720024 —— —— —— —— 432020720209 2008520143201442015220153201872018720207 2006720086 5220223199192004820049201232013720213683320213202112 200942013420174 200612 20241031— 20241031956600956.SH834918 2025326202541020255232025522025523 202552320255232025522025523 13.51B(1) 20251231 Ta