华昊中天医药-B2025中期报告

（ 於中華人民共和國註冊成立的股份有限公司） 股份代號 : 2 5 6 3 2025中期 報告 02 04 22 30 34 36 38 40 69 73 Tang LiQiu Rongguo Tang LiQiu Rongguo 2025523 Tang Li 20255232025523 1222206 333304–3309 Tang Li Qiu Rongguo H 1831717121716 223121202B 2563 223121202B www.biostar-pharm.com 246802 20241031 (1)2010122025716202571620257182025202563020242024 (2) 1. 1920212010 IIIIIIIIIIINDA II/IIIIIIII/IIIII/III HER2III HER22/3AC2025HER2 NSCLC II Cancer Pathogenesis and Therapy (2024, 2(2), 103–111)NSCLC20194202182621ORR19.0%DCR81.0%PFS4.41271.0% ITTNSCLCITT(A)ITT(B) NSCLCIII NSCLCNSCLCIIIII40% PD-1IIIICBR53%70%ORR20%40%PD-1PD-1GCESCCGC2723523ORR65.2%PR4CBR100%mPFS6.1ESCC2018612ORR33.3%CBR100%2024ASCO2025ASCO HER2II2024ASCOJAMA Oncology202255202310254735CNS121–23CNS-ORR42.6%2024520(PFS)7.715.1 HER2II2025ASCO34513109202412210.464.7%6CNS-ORR67.6%CNS-CBR88.2%CNS-PFS15PFS6TEAE1–22/363–4TEAE10% II20246IIIND20249IND20251 II20243FDAODD20246IIIND II IC50II2024CSCO2011(PR)3(SD)5(ORR)27.27%(DCR)72.72%(mOS)9.571–2FDAODD 2024ASCOsipuleucel-T(mCRPC)IIUTD1mCRPC202232325mCRC674.2100%96.0%80.0%PSA16.0%rPFSOS4.97.1101PR4SDORRDCR10.0%50.0%(TRAE)(mCRPC) III/III I 50mg/m2/5275mg/m2/575mg/m2/7321(DLT)3(AE)75mg/m2/72475mg/m2/563PR13SDDoT2–13(TEAE)1/230mg/m260mg/m2(AUCinf)3119.708h*ng/mL2188.184h*ng/mL(F%)35.1% I50264427PR12SDORR61.4%(CBR)88.6%2018ASCOORR49.8%CBR65.8%TEAE2025pre-NDA IIT 33153117PR9SDORR54.8%CBR83.9%IIT 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/III 20243FDAODD2024II/IIIMRCTFDApre-INDType CII78III700(OS)(PFS)ORRII/IIIINDFDACDE2025 II/III II72III480II/IIIINDCDEFDAIND II3564PR2SD60% III TNBC4403(IDFS)(OS) (ADC)ADCADC 2. 20241114301015.SZ®2025112024115,000 3. PCTPCTPCTPCTPCTPCT 4. NSCLC — II/IIIIIIII/IIIII/III —ADC ADCADCADC — cGMP — — 14.8202463033.155.4% 120246304.878.3% 202463028.351.5%202563013.7202563093%202463085.5% 2025630548,0002024630527,000 202463035.244.6%202563019.5 202463022.135.6%202563014.2 202463054.624.3%202563041.3 20256308,038,00020246307,952,000 20246301.820256302.5 20246300.11,830%20256301.7 20246302025630 202463070.616.5202563054.0 1.2.3. 20241231620.16.8%2025630578.1 2025630644468.665.812.514.536.740.65.4202563065.9530.10.32.90.18.90.6 2025630569.420241231607.66.3%(i)(ii)(iii)(iv) 202563020256305% 2025630 2025630 2025630131202563031.76202463042.18 2020112021120221——D. A. 2025630XV(i)XV78(ii)352(iii) 2025630352 B. 2025630XV23336 HXV235% (1)147,867,143216,720,857H(i)202,132,857(ii)14,588,000(2)Tang LiQiu RongguoTang LiQiu RongguoQiu RongguoTang Li(3)Tang LiQiu Rongguo5.59%TangLiQiuRongguo51%49%Tang LiTang Li0.12%Tang LiQiu Rongguo51%49%Tang LiQiu Rongguo(4)Tang Li5.27%Tang LiTang Li(5)Kevin ZhangHannah Qiu Tang LiQiu RongguoBaygen QT Inc.43.5%43.5%6.5%6.5%Kevin ZhangHannahQiuTangLiTangLiQiuRongguoKevinZhangHannah Qiu2021821Kevin ZhangHannah QiuTang LiBaygen QT Inc.Tang LiBaygen QT Inc.Tang LiTang LiBaygen QT Inc.——(6)4.49%1.50%(7)H 1614,588,0001.00H195.892025630 12024112220241125238.0022.00 (i)(ii)(iii) 14.075%1414A 220241120BiostarPharma,Inc.US-Biostar5.0US-Biostar1.5US-Biostar20241128US-Biostar1.5US-Biostar20241223US-Biostar1.520241226 14.075%1414A 20241112 1.202522013202541 2. 3.2025425 20242024 202532620254102025523 20255232025523 20251113.51B(1) 2024 C3 2025630 13.2013.2113.22 6302024630 2025630 3.21C13.10(2)3.21 Tang Li 2025828 () 2002711202158 9111010874157874XP 223121202B 20241031 32— 2024 12 2025630 202563020251–6 H201012202511 11123111630 12 2024 2025630 1 (1)202511 2 1 2 20246302025630 2025630 1 2 3 10% 2025630 [2015]4 2 25%15% 21%8.84% 28.25%216.5% 2025630 (1) 25% 15%202410292024202563015% 2020232021112030123115%70%2024202563015% (2) 2024202563020242025630 (3) 201832120177201832828.25%216.5%20242025630 2025630 (ii)202411CFundSP5,000,00035,942,00020256305,000,0003,579,30002025630 2025630 2025630 2025630 2025630 2024122035,000,0004.7619%2025630 1 2025630 2 1. 2. 3. 2025630 2025630 1. 2. 3. 2025630 2025630 2025630 2025630 2025630 (i)2024114202411650,000,00047,170,00042,453,0004,717,000 2025630 2025630 2025630 2025630 2025630 (i) (ii) 20256301.1%5.0% 2025630 1 2 20242025630 2025630 (a) Tang LiQiu Rongguo 2025630 (b) 10 2025630 2025630 (i) 13 — —— 2025630 (i) (ii) MDR≤ 1,000MRCTMTDNCCNNDANSCLCOCODDORROS