先声药业2024年度报告

245674077103112119120121123125127230 (1) 公司資料 332 101 183171712-1716 53 20E7703 108 699-18 http://www.simcere.com 2096 202412 31 •66.35202366.080.4%•49.2874.3%202347.563.6%•21.7432.8%202319.6910.4%18.1127.3%202314.1528.0%12.9819.6%202315.7617.6%13.5220.3%202316.4818.0%•7.3320237.150.182.6%•110.1820237.192.9941.6%(i)(ii)(iii)(iv) 公司概覽 20246016 •202412 311410045NRDL •TCEADC(mRNA)AI20241231974174525 •2024123138036420241231294 •202412314,050323,00017,000200 •GMPGMPFDA •(SAB) 2024 2025®®2024®® 202482024FDA®EGFR®74.3%SIM0500BCMA-GPRC5D-CD3 TCE 2025 管理層討論及分析 2024920%202415045% 202412 31 •®FOLFIRIRAS/BRAFmCRC•®AIS® NDANMPA •®VEGF•®DORA•1(PA) NRDL •2024®®NRDL®NRDL III •SIM0270SERDCDK4/6ER+/HER2-•TGRX-3261ALK/ROS1NSCLC1•IL-4RTh2 ®®NSCLC POCPCC2IND3FPIFIH4LPI5 4FIHSIM050120243SIM050020245SIM0508202412FPISIM0237NMIBCI20241®II20244III20247III20247III20248SIM0270ER+/HER2-III202411SIM0505I20252 5LPI®IIa20243®III20243®III202411SIM0278I202412III20251 IIIIII •20241 3®IIISCORES2024311NMPANDA20243 15•20241 18(The New England Journal of Medicine)®II/IIICOVID-19®•20242 19(JAMA NEUROLOGY)®AIS IIITASTE-SL®90mRS0~164.4% vs. 54.7% BD •20249 2NSCLCTGRX-326•20251 13AbbVie Inc.ABBVAbbVieAbbVieSIM0500•20251 17SSTR4FZ002-037•2025119® 2.0 •12•20244150mg (1ml)B (ESG)(MSCI)2024ESGA 20252.0 •(BD) • • • 60NDA1III112TCEADC ®®®®®®®® ® AIS®20207202012NRDL20241231®28%1315,500 NRDL •202411®2024NRDLNRDL 2024202511 •20245TASTETASTE-SL(LAA) •20245(EXPAND)EXPANDAISAISNIHSS ® ®AIS®® •20248®FDA •202412®NMPAAIS •20242•JAMA NEUROLOGY®AISIIITASTE-SL®AIS ® ®2017NRDLCSCONSCLC •202411IIILPI •20241®•20245ASCO®•202472024®IVNSCLC12A•20249(ERS)®NSCLC 管理層討論及分析 •20249272024CSCO® •202412ESMO Asia®II •2024122024® ® ®PD-(L)1PD-(L)120203 •202432024(ELCC)®NSCLCII •20245®CSCO2024 CSCOI2A2024 CSCOII2ACSCO2024I2A2024 CSCOII32024 CSCOIII32024 CSCOIII2B •20245ASCO®•202492024(WCLC)®•202492024(ESMO)®•202412MDT2024®dMMR/MSI-H•202512024®mCRC(MSI-H)(dMMR) ® 46 (CDK4/6)First-in-class (FIC)20208G1 Therapeutics,Inc.®20212FDA20227®NMPA 20234®202312®NMPA(NCCN)CSCO NRDL •202411®2024NRDL NRDL 202420251 1 •202412®100mg •20244CSCO2024(ES-SCLC)®II2AI1A®2A1A•202492024(WCLC)•20249(ESMO)®II•20249CSCO(ES-SCLC)NSCLCII•202412(ESMO Asia)•20251Cancer Treatment and Research Communications3253/44 ® 2.4EGFRFOLFIRIRAS/BRAFmCRC® •20246®NMPAmCRCEGFR®mCRC NRDL •202411®mCRC2024NRDLNRDL 2024202511 ® ®2017NRDL2012®100DMARDs •20246(EULAR)•20247SMILEChinese Medical Journal•2024112024(csDMARDs) ® 3CL20211117®313173,72187 •20247®NMPA •20241(The New England Journal of Medicine)®COVID-19II/III351,092(95.9%)874(76.7%)®®3CL •2024514 •20249Infection and Drug ResistanceCOVID-19COVID-19 NDA ® IdorsiaDORAAB®®®12®®(EMA)DORA®9 •20243®III205(LPI) •20247®NDANMPA ® Apexigen, IncPyxis Oncology, IncVEGF •20243®NDANMPA •20246SCORES2024 ASCO(1)BIRCPFS(2)VEGFPARPPFS(3)OS(4)BIRC(DCR)(DOR)(5) (PA)1 (PA)24 •20242III•20251IIILPI•20252NMPAIND2 NDANMPA •20244II/III26.543% III SIM0270 (SERD) SERDSIM0270SERD •20249CDESIM0270 III•202411SIM0270 III TGRX-326ALK/ROS11 ALK/ROS1NSCLC1TGRX-326NSCLC •TGRX-326ALK/ROS1NSCLCIII (IL-4R)2 IL-4RIL-4RIL-4IL-13IL-4RIL-4IL-13Th2Th2 •20247IIIFPI LNK01001 (JAK1)3 LNK01001JAK1RA(AS)(AD)3IIJAK20223LNK01001RAAS •LNK01001RAIII I SIM0348TIGIT/PVRIG IgG1TIGIT/PVRIGTIGITPVRIGCD155/TIGITCD112/PVRIGSIM0348 SIM0237PD-L1/IL15v PD-L1IL-15/IL-15RsushiPD-L1PD1/PD-L1IL-15SIM0237PD-L1IL-15 •20241SIM0237NMIBCIFPI SIM0501USP1 1 (USP1)SIM0501PARPiHRD •20241SIM0501NMPAINDSIM0501•20243FIH SIM0500GPRC5D-BCMA-CD3 GPRC5D-BCMA-CD3TCD3GC5D(GPRC5D)B(BCMA)SIM0500MMT •20243SIM0500INDFDANMPA•20244SIM0500FDA≥3(PI)(IMiD)CD38•20245FIH •20251AbbVieAbbVieSIM0500AbbVie10.55AbbVie SIM0395 (Paxalisib) PI3K/mTORIIPaxalisibMGMT2018PaxalisibFDAGBM2020FDA(DIPG)20213KaziaSIM0395 •20247KaziaPaxalisib(SOC)IIIGAM-AGILE SIM0508Pol PolDNAMMEJDNA •20248SIM0508INDNMPAFDA•202412 SIM0505 (CDH6-ADC) CDHIISIM0505CDH6ADCCDH6SIM0505ADC 20251SIM0505INDFDANMPA •20252 SIM0686 (FGFR2b-ADC) FGFR2bADC(FGFR)(FGF)FGFR1FGFR2FGFR3 FGFR4ADC •20254SIM0686INDNMPA SIM0278 (IL2 mu Fc) T(Treg)IL-2Fc(IL2 muFc)SIM0278TTregTreg20229Almirall, S.A.AlmirallAlmirallSIM0278 •202412SIM0278ILPI SIM0800 (AQP4) 4 (AQP4)First-in-class201910Aeromics, Inc.SIM0800 IND 40FICBest-in-class (BIC) SIM0506SOS1 SOS1SIM0506pan-KRAS SIM0506INDNMPAKRAS 202412 3166.35202366.080.4% 21.7432.8%202319.6910.4%18.1127.3%202314.1528.0%12.9819.6%202315.7617.6%13.5220.3%202316.4818.0% •2024123115.23202319.6022.3%23.0%202329.7%6.7•2024123114.10202315.639.8%21.3%202323.7%2.4•202412311.1320233.9771.5%1.7%20236.0%4.3 202412317.3320237.150.182.6% (i)(ii)(iii)(iv) 2024123110.1820237.192.9941.6% (1) (2)2024 2024123113.911.512023®®2024123119.43202312 3120.074.98202312310.12202412 3110.592023123112.2110.512023123110.152024123110.590.86%1.07% 20241231200.4%20231231209.9%38.6%202312 3133.5%20249.70202412 3132.6% 202412 310.440.24202412311.1120241231 20