先声药业2025中期报告

4 5 7 34 46 47 48 49 51 54 公司資料 183171712-1716 332 101 53 20E7703 108 699-18 2096 1333304-3309 http://www.simcere.com 20256 30 •35.85202431.1415.1%•27.7677.4%202422.0326.0%•12.4934.8%20249.0937.3%8.7424.4%20246.1941.1%8.7824.5%20248.503.3%5.8416.3%20247.3620.5%•6.0420244.571.4732.2%16.5120245.381.1321.1% 公司概覽 4,179313,00017,000200 GMPGMPFDA 202563010045NRDL TCEADCAI2025630963183532 (SAB) 2025630 管理層討論及分析 20251+61660306 ®®®®®®®®®®®®®NDA 60IND1FIH2LPI3 60NDA112ADC 管理層討論及分析 ®®®®®®®®®®202563027.7677.4% ® ®AIS®20207202012NRDL202411NRDL 2025630®29%915,900 •20254 管理層討論及分析 ® ®AIS® ® ®202412AIS20248®FDA •20255TASTE-SVDESOC ® ®DORA®AB®®®(EMA)DORA2025 2®A®11 •20256 17® •202512A •2025633IIISLEEP50 mg 管理層討論及分析 ® ®®2017NRDLCSCONSCLC •202512024®++++2B++2B •202562025(ASCO)®(1)II(2)PD-1 ® ®PD-(L)1PD-(L)120203®® •20251(ASCO GI)®•20255®CSCO2025 CSCOI2025CSCOII•202562025(ASCO)®11 管理層討論及分析 ® ®46 (CDK4/6)First-in-class20208G1 Therapeutics, Inc.®20212®FDA20227®NMPA20234® 202312®NMPA(NCCN)CSCO202411®NRDL •20255®CSCO2025 CSCOI•202562025(ASCO)®4 ® ®EGFRFOLFIRIRAS/BRAFmCRC®20246®NMPAmCRCEGFR®mCRC202411®NRDL •202542025 CSCO®2025 CSCORASBRAFB+FOLFIRIIB+FOLFIRIII •20255®IIINatureSignal Transduction and TargetedTherapy40.8PFS®PFS13.13.5OS®OS28.323.1EGFR 管理層討論及分析 ® ®Pyxis Oncology, Inc.VEGF ®VEGF®VEGF®VEGF(VEGFR2) ®®IIISCORES(BIRC)PFSPFSOS •20256 30®1 ® ®®2017NRDL2012®100DMARDs •202552025csDMARDs®csDMARDscsDMARDsbDMARDstsDMARDsA1acsDMARDsA1aB3 •202562025(EULAR)®csDMARDs 管理層討論及分析 ® 3CL2021111720247®NMPA •20254Antimicrobial agents and chemotherapy •2025728 NDA (PA)1 (PA)24 •20251IIILPI•20252NMPAIND2 •20253NDANMPA•20259NDANMPA211 (IL-4R)2 IL-4RIL-4RIL-4IL-13IL-4RIL-4IL-13Th2Th2 •20257NDANMPA •III 12Rademikibart 管理層討論及分析 III SIM0270 (SERD) SERDSIM0270SERD •SIM0270CDK4/6ER+/HER2-III TGRX-326 (ALK/ROS1)1 TGRX-326ALK/ROS1NSCLC1TGRX-326NSCLC •TGRX-326IIILPI LNK01001 (JAK1)1 LNK01001JAK1(RA)(AS)(AD)3IIJAK120223LNK01001 •20253LNK01001RAIIILPI 管理層討論及分析 I SIM0237PD-L1/IL15v PD-L1IL-15/IL15RsushiPD-L1PD1/PD-L1IL-15SIM0237PD-L1IL-15 •SIM0237NMIBCI•CDESIM0237BCGNMIBCFPI SIM0501USP1 1USP1SIM0501PARPiHRD •SIM0501I SIM0500GPRC5D-BCMA-CD3 GPRC5D-BCMA-CD3TCD3GC5D(GPRC5D)B(BCMA)SIM0500MMT •20256SIM0500IFIH 20251AbbVieAbbVieSIM0500AbbVie10.55AbbVie SIM0395 (Paxalisib) PI3K/mTORIIPaxalisibMGMT2018PaxalisibFDAGBM2020FDA(DIPG)20213KaziaSIM0395 管理層討論及分析 SIM0508Pol PolDNAMMEJDNA •SIM0508I•20258SIM0508INDNMPA SIM0505 (CDH6-ADC) CDH6IISIM0505CDH6ADCCDH6SIM0505ADC •20252SIM0505IFIH •20256NextCure, Inc.NextCure(i) NextCureSIM0505(ii) NextCureITOPOiADC(iii)ADC SIM0686 (FGFR2b-ADC) FGFR2bADC(FGFR)(FGF)FGFR1FGFR2FGFR3 FGFR4ADC •20254SIM0686INDNMPA•20255FIH•20257SIM0686IND FDA SIM0609 (CDH17-ADC) SIM0609CDH17I (TOP-I)CDH17 •20259SIM0609INDNMPA 管理層討論及分析 SIM0278 (IL2muFc) TTregIL2Fc(IL2muFc)SIM0278TTregTreg20229Almirall S.A.AlmirallAlmirallSIM0278 SIM0800 (AQP4) 4 (AQP4)First-in-class201910Aeromics, Inc.SIM0800 202563014914820256303179932 202563035.85202431.1415.1% 12.4934.8%20249.0937.3%8.7424.4%20246.1941.1%8.7824.5%20248.503.3%5.8416.3%20247.3620.5% •202563010.2820246.1268.0%28.7%202419.7%9•20256306.3220245.6611.7%17.6%202418.2%0.6•20256303.9620240.4611.0%20241.5%9.5 20256306.0420244.5732.2% 管理層討論及分析 (i)(ii)(iii)(iv) 20256306.515.3821.1% (1) (2) 管理層討論及分析 20256308.678.63202563026.712024123119.435.19202412314.98202563010.592024123110.5910.512024123110.51202563010.590.95%1.15% 20256 30173.3%20241231200.4%42.6%2024123138.6%(1)20251AbbVie Inc.SIM05003.58(2)20256Idorsia3.59(3)20256®0.210.70 20256300.410.2220256301.0920256302025630 20256 30 202552,0932,093 20256 30 20256 30 20256 30 管理層討論及分析 20256 306,815202563011.0120215202021(1)(2) 20253 252021451,777,0001,777,00020253 25 2025630571XV(i)XV78(ii)352(iii) (1)20256 302,474,697,618 (2)Simcere Investments Group LimitedSIGP&H Holdings Group Ltd.P&H HoldingsRightWealth Holdings LimitedRight Wealth1,787,828,668(i)Artking Global LimitedArtkingSimcere PharmaceuticalHolding LimitedSPHL592,810,031950,431,689(ii) SIGFortune Fountain Investment Limited FFI116,259,578128,327,370(i)229,600(ii)56,000202563056,000 企業管治及其他資料 (3)(i)1,228,333(ii)2021554,734554,7342025630554,734 (4)(i)229,600(ii)202156,00056,000202563056,000(iii)1,787,828,668 2025630XVXV78352 2025630XVXV23336 (2)1,787,828,668(i)ArtkingSPHL592,810,031950,431,689(ii)SIGFFI116,259,578128,327,370 企業管治及其他資料 (3)P&H Family TrustP&H HoldingsP&H Holdings(4)Right WealthRight Wealth(5)(6)(7)Artking592,810,0311,195,018,637(i)ArtkingSPHL950,431,689(ii) SIGFFI244,586,948Artking(8)1,787,828,668(i)Simcere HoldingSPHL950,431,689(ii)837,396,979(a)Artking592,810,031(b)SIGFFI244,586,948ArtkingSIG FFISimcere HoldingSimcere Holding(9)1,787,828,668(i)Excel InvestmentsSPHL950,431,689(ii)837,396,979(a)Artking592,810,031(b)SIGFFI244,586,948ArtkingSIG FFIExcel InvestmentsExcel Investments(10)SPHL950,431,689837,396,979(i)Artking592,810,031(ii