华昊中天医药-B2024年报

02030506092836607496101102104105107161162168 20242002191916IIIBIIICIV(NSCLC)202120212010-II/IIIBG22BG18BG44 Tang LiQiu Rongguo202520252025Tang LiQiu RongguoTang LiQiu Rongguo Tang Li2911110133 2024523523523 3304–3309 2024 H1831717122563www.biostar-pharm.com20241031 223121202B223121202B2468 1716 02 202420242024101II20243FDAI7(CSCO) 20243FDA7FDAII9CDEIIIII12PD–1712FDACDEII/III6ADCBG22BG182024(ASCO) 7.9%45.6%17PCT13 2024189.620242023 143.820231231202420235.333.535.1%2024BD 20242025 Tang Li 20241.20212010III 19IIIIIIIINDA 2024II/IIIHER2HER2 II/IIIIIIII/III–––•HER2III2/3AC2025 2024•NSCLC IICancer Pathogenesis and Therapy (2024, 2(2), 103–111)201919.0%DCR81.0%PFS-70-60-50-40-30-20-100102030405060PDABSDPR-7001234-60-50-40-30-20-1001020304050ITTNSCLC(A)ITT(B) 420214.41271.0%(N=22)(N=22)567ITT NSCLC82621ORRORR: 15.4% (95% CI: 4.4–34.9)DCR: 69.2% (95% CI: 48.2–85.7)PRSDPD8910111213 2024NSCLCIICBR53%PD-1GCESCC2365.2%PR4CBR1833.3%CBR100%2024ASCO*** •NSCLCIIINSCLC40%2025•PD-1IIII70%ORR20%40%PD-1GC27523ORR100%mPFS6.1ESCC20612ORR2025ASCO*20.00.0-20.0-40.0-60.0-80.0-100.0*(PPS) III 202420.00.0-20.0-40.0-60.0-80.0-100.0•HER2202420231025473(PFS)7.715.1100806040200-20-40-60-80-100 IIASCOJAMA Oncology20225535CNS121–2CNS-ORR42.6%2024520(n=46) 2024•HER2II2025ASCO34513109202412210.464.7%6CNS-ORR67.6%CNS-CBR88.2%CNS-PFS15PFS6TEAE1–22/363–4TEAE10% 2024•IIII•II20243FDA•IIIC502024CSCO11(ORR)27.27%1–2FDAODD•sipuleucel-TUTD1mCRPC6780.0%rPFSOS4.97.1ORRDCR10.0%50.0%(mCRPC) 20246IND20249IND20251ODD20246IIINDII20(PR)3(SD)5(DCR)72.72%(mOS)9.572024ASCO(mCRPC)II202232325mCRC4.2100%96.0%PSA16.0%101PR4SD(TRAE) 2024I50mg/m2/575mg/m2/7(DLT)3(AE)2475mg/m2/3PR13SD,1/2(AUCinf)3119.708502625PR14SDORR56.8%2018ASCOTEAE27PK25mg/m2/5250mg/m2/275mg/m2/670mg/m2/27DLT/17511×2 II/III•I52375mg/m2DoT2–1330mg/mh*ng/mL2188.184h*ng/mL(F%)•(CBR)ORRpre-NDA•IIT3313PR9•I100mg/m293470mg/m2/ 75mg/m2/21/756(TEAE)260mg/m235.1%I4488.6%UTD149.8%CBR65.8%202515SDORR 48%CBR81.5%21/35215100mg/m2(MTD)75mg/m/1CR1PR7SD 2024×2TEAE1/2≥ 20%ASCOPDSD8 06 04 02 00- 2 0- 4 0- 6 00 0 20 0 6* CR(%)01806040200-20-40-60-80-100* CR(%) DoT12ORR18.2%CBR81.8%2025SDPDSDSDSDSDSDSDPRSDCR*0 1 20 0 70 0 90 0 40 1 90 1 00 0 50 1 60 0 1525 mg/m2/550 mg/m2/575 mg/m2/5100 mg/m2/770 mg/m2/23456789PDSDPRCR* 2024ODD2024MRCTFDA78IIIII/IIIINDFDACDEIII480II/IIIIND4403 •PD-L1II/III20243FDAII/IIIpre-INDType CII700(OS)(PFS)ORR2025•II/IIIII72CDEFDAIND2025•IIITNBC(IDFS)(OS) 2024•(ADC)2.202411142024113.PCT2041 ADCADC301015.SZ®2025115,000PCT2024PCTPCT 20245ml:50mgMAHNSCLCII/IIIII/III 4.••202220242023024703•3ml:30mg3ml:30mg2024123ml:30mgH20247320•5.——IIIII/III 2024—ADCADC——cGMP—— ADCADC 202466.67.9%19.845.6%46.830.5%202412100%202470.3%(iii)26.761.9116.32023IIT57,000 31123120232023 71.92023123110.8202312312023123161.185.0%20231231(i)(ii)(iv)202331.715.6%2024202395.435.1%202443.919.2%202452.3126.58.1%2024202456,0002023 20242023189.6(%)1.2.3.20231231620.120241231268.867.131.4202412314.70.90.7 45.82024143.8202412312023128.88.413.4%589.85.1%20241231699.3189.7106.028.18.279.272.9 2024607.620231231(ii)202414720241220231231120.3 20241231576.05.5%2024123112315%202412312024123131 (i)2024123180.5 202416(iii)35,942,0009315,000,000 2020112021120221—— D.20241231202412315,000,00020241235,942,000 2024202412315,000,00013(ii)2024123120241231500 (i)35,942,0001313(i)20241231(ii)(iii)(i)13(ii) 20242025 1231 202420051202072023122016211(i)1983719858919887(iv)19909(v)199421998419985200410Kosan Biosciences, Inc.(ii)1988107202132002720231220151 TangLi622021320227Biostar Pharma, Inc.2024401983(ii)1985(iii)1988819891219941(vi)(vii)20061220129(i)19837(iii)199484040Qiu Rongguo6320022020720227Biostar Pharma, Inc. 202440(i)1990219929Pharmaceuticals,Inc.(iv)199812000200010200112Kosan Biosciences, Inc.(vii)200612201291983719878405020188202120152020031201519986422023313AustarPharma LLC(ii)2011820129201511 19861219901(ii)(iii)199210199712Onyx10(v)(vi)2002120026Panomics, Inc.19975153202312620169199895201312202312(i)20091020107(iii)201211(iv)20151120223 20242020202220221(ii)198810619957(iii)19941(iv)199579201512 2015201611320172018333200672011670202312201512(i)19838198881994619941996121997920061993819837 2024482025520042024552022318(i)20071(iv)20167(vi)20181(vii)20181(ix)2022320221991719941998720065 20017200478200612200712019620197(ii)2018(iii)20161(v)20169(viii)202151262001 202420224202516836202211202338860550800120227202112GEM2024251525CPA 5520255620231202392022620227GEM861346220255CPACPA 202457201622021(i)200111(iii)20146(v)20168(vii)2016201910(x)20215199071999392016122020820222009649202132018122002820032199920024 3(ii)20138(iv)201411(vi)201736(viii)(ix)20191172009101200337 2024————————202072020920144201522008620049201237202132021320134 Tang LiQiu Rongguo200820182006202112200920172006 435201432015320187720207752202231991920048201368334412 202420241031—20241031182024927202420253262025202552320255232024102313.51B(1) 4102025523 20241231Tang LiQiu Rongguo2025523202552320255232024