复宏汉霖2025中期报告

2025中期報告 使命 持續創新，卓越運營；以優質生物藥，造福全球病患 願景 專注提供質高價優的生物藥，成為全球最受信賴的創新生物製藥公司 2411373839404142446172 公司資料 Wenjie Zhang18Yihao Zhang9410 Wenjie Zhang1 2Wenjie Zhang1 36 345Xingli Wang67 Wenjie Zhang1235Xingli Wang867 8Yihao Zhang910 1112 8Wenjie Zhang12 84 1.Wenjie Zhang20253 24 2.20253 24 3.20258 29 4.20256 27 公司資料 97927 2Wenjie Zhang1 188B811 55 36719901 288224 1617 H 183171712 1716 2696 www.henlius.com 5.20258 296.20258 297.20258 298.20256 279.Yihao Zhang20258 2910.20258 2911.20251 3112.20251 3113.202420258 820258 1220258 2920258 820258 12 1.20256302,819.520246302,746.173.42.7% 2.20256 30995.420246 30825.6169.8 3.20256 30390.120246 30386.33.8 4.202563040.62 運營摘要 93566085 1 Hetronifly®PD-1 ®(sqNSCLC) 20252®Hetronifly®(ES-SCLC) 202556®(ES-SCLC) ®30(Orphan-drug Designation) HLX14BILDYOS®BILPREVDA HLX14202589HLX14(FDA)(EC)BILDYOS®BILPREVDA® ®HERCESSITMZercepac® ®50 20252Dr. Reddy’s Laboratories SAHLX15CD38 20253® 20254Alvogen Korea Co., Ltd.® 20254Sandoz AG42HLX13CTLA-4 2 202520256FBDBiologics LimitedSIRPα-Fc20258HER2(ADC) GQ100520258® 5010(ADC) •20251HLX43PD-L1®1b/2(IND) •20252HLX99(IND)(FDA)(ALS•20253HLX79®2(IND)•20257HLX43PD-L1HLX07EGFR2(IND) 運營摘要 •20259HLX13CTLA-4(HCC)1(IND)(FDA)•20259HLX17PD-11(IND)(FDA)•20259HLX37PD-L1VEGF1(IND)•20259HLX22HER2HLX87HER2HER2(BC)HER2(BC neo)(IND) 3 HLX43PD-L1 20251HLX43®1b/2(IND)20254 20251HLX43(ESCC)2HLX432 2025689HLX43(NSCLC)220257 202579HLX43(TC)1 HLX22HER2 202535HLX22(GC)(FDA)(EC)(Orphan-drug Designation) 20254HLX22HER2HR(BC)2 202537HLX22HER23320254 ® 20251®(LS-SCLC)3 20251®(ES–SCLC)20256® 20256®(mCRC)3 ®(ES-SCLC)100 202513HLX11HER2II(FDA)(EMA) 20254VEGFHLX04-O(wAMD)3(wAMD)(NDA)2025 8 20255HLX13CTLA-4(HCC)1/3 20258HLX79®2 20259HLX17PD-11 運營摘要 4 20256HLX11HLX14GMP20258 管理層討論與分析 1.02.0 935660852025®(ES-SCLC)20252202589HLX14(FDA)(EC)BILDYOS®BILPREVDA® 12(IND)11(NDA)5030 1 •20252Dr. Reddy’s Laboratories SAHLX15CD38•20253®•20254Alvogen Korea Co., Ltd.® •20254Sandoz AG42HLX13CTLA-4 FARMA DE COLOMBIA S.A.S®20258® 2 ®Hetronifly®PD-1 ®® •20251®(sqNSCLC)•20252®Hetronifly®(ES-SCLC)•202556®(ES-SCLC) ®30(Orphan-drug Designation) H L X 1 4B I L D Y O S®BILPREVDA® HLX14202589HLX14(FDA)(EC)BILDYOS®BILPREVDA® ®HERCESSITMZercepac® ®®50AbbottAccord Eurofarma PT Kalbio Global Medika LaboratorioELEA Phoenix S.A.®100 管理層討論與分析 ® ®AbbottEuropharma BostonOncology, LLCGetz Pharma®®® 3 •GMP20256Federal Agency For Medicines And Health ProductsCertificate of GMP Compliance of a ManufacturerGMPHLX11HLX14GMPFDAHLX11HLX14GMPHLX11GMPHLX14ISO 14001ISO45001International Accreditation ForumIAFDeutsche Akkreditierungsstelle GmbHDAkkS •200201936,000(PFS)2025820256Federal Agency ForMedicines And Health ProductsCertificate of GMP Compliance of a ManufacturerGMPHLX14GMP 1 T(T Cell Engager)(ADC)HanjugatorADCADC(AI)HAI Club 202520256FBD Biologics LimitedSIRPα-Fc20258HER2(ADC) GQ100520258® 5010(ADC) 20251PD-L1ADC + PD-1+CD20(IND) •20251HLX43PD-L1®1b/2(IND)•20252HLX99(IND)(FDA)(ALS 管理層討論與分析 •20253HLX79®2(IND)•20257HLX43PD-L1HLX07EGFR2(IND)•20259HLX13CTLA-4(HCC)1(IND)(FDA)•20259HLX17PD-11(IND)(FDA)•20259HLX37PD-L1VEGF1(IND)•20259HLX22HER2HLX87HER2HER2(BC)HER2(BC neo)(IND) 2 HLX43 (PD-L1 ADC)HLX22 (HER2)®(PD-1)HLX04-O (VEGF)(NSCLC)(GC)(BC)(SCLC)(wAMD)(HCC)30 HLX43PD-L1 •20251HLX43®1b/2(IND)20254•20251HLX43(ESCC)2HLX432•2025689HLX43(NSCLC)220257 •202579HLX43(TC)1 20259HLX4312025(WCLC)HLX43(CPI)(NSCLC)(ORR)37.0%(DCR)87.0%NSCLCORR30.0%3/102.0 mg/kgHLX43NSCLCORR40.0%EGFRNSCLCHLX43ORR46.7%;2.5 mg/kgHLX43ORR60.0%ORR36.4%(DCR)100.0%HLX43PD-L1(TPS) ≥ 1%PD-L1(TPS < 1%)ORR34.4%38.1% HLX22HER2 •202535HLX22(GC)(FDA)(EC)(Orphan-drug Designation) •20254HLX22HER2HR(BC)2•202537HLX22HER23320254 管理層討論與分析 HLX22HER2+22025(ASCO)HLX22++++28.528.7(IRRC)(PFS)(95% CI: 16.2,) vs 8.3 (95% CI: 5.7, 21.4)(ORR)87.1% (95% CI: 70.2, 96.4)vs 80.6% (95% CI: 62.5, 92.5)HLX22HER2(G/GEJC) ® •20251®(LS-SCLC)3•20251®(ES-SCLC)20256®•20256®(mCRC)3•®(ES-SCLC)100 ®®(mCRC)2/322025(ASCO GI)202463031.0®ABPFS16.6 vs. 10.7HR 0.66, 95% Cl 0.37-1.19DOR17.7 vs. 11.3 HR 0.45, 95% Cl 0.20-0.98XELOXmCRCMSS(mCRC)®16(International Gastric Cancer Congress, IGCC 2025)®2 •202513HLX11HER2II(FDA)(EMA) •20254VEGFHLX04-O(wAMD)3(wAMD)(NDA)2025 8•20255HLX13CTLA-4(HCC)1/3•20258HLX79®2•20259HLX17PD-11 管理層討論與分析 1,500®®6 1®® ®®150mg60mg®HER2® ®HER(TKI)HER2®®HER2510HER2®HER2 管理層討論與分析 2® ®PD-1(JAMA)(NatureMedicine)Cancer CellBritish Journal of CancerCSCOCSCOCSCOCSCO ®(sqNSCLC)(ES-SCLC)(ESCC)(nsNSCLC)(ES-SCLC)PD-1PD-1 3®®® 2019® ®® ®® 2025 20252026 1 •®(ES-SCLC)(sqNSCLC)•HLX11(BLA) 管理層討論與分析 •HLX14•®(ES-SCLC)100•®®®®®HLX11HLX14 HLX04-O 2 (AI)HLX97 (KAT6A/B)HLX18 (PD-1)HLX3901 (DLL3 × CD3 × CD28)HLX316 (B7-H3 × Sialidase)(IND) 3 2025HLX04-OHLX14GMPHLX14 Good Supply PracticeGSP •®®HER2®929® •®Hetronifly®2025(ES-SCLC)PD-1® •® •®® 管理層討論與分析 40.62 2,819.52.7% 1 ®20208®1,407.41.2Zercepac®HERCESSI™36.8 ®20223®®593.9Zerpidio®Hetronifly®3.8 ®