先声药业2024中期报告

4 5 7 31 43 44 46 48 51 公司資料 (1) 公司資料 183171712-1716 332 53 20E7703 108 699-18 2096 1333304-3309 http://www.simcere.com 20246 30 •31.14202333.8217.9%•22.0370.7%202324.138.7%•4.57202322.7418.1779.9%25.3820233.941.4436.5% 公司概覽 20246303,900323,00017,000200 GMPGMPFDA 20246301410040NRDL TCEADCAI2024630880160460 (SAB) 管理層討論及分析 202420246202420247 5 ®®®®®®®®®®NDA 60IND1FPI/FIH2LPI3 •12•20244150mg (1ml)B 管理層討論及分析 6016NDA44I/II1240ADC 管理層討論及分析 管理層討論及分析 202463022.0370.7% ® ®2017CSCONSCLC •20241® •20245(ASCO)4112 ® ®PD-(L)1PD-(L)12020330 •202432024(ELCC)®(NSCLC)II •20245(ASCO)®945 管理層討論及分析 ® 46 (CDK4/6)First-in-class20208G1Therapeutics, Inc.G1®2021213®FDA2022712®NMPA20234 28®20231220®NMPA (NCCN)CSCO •20241®100mg •20244CSCO2024(ES-SCLC)®2AI1A®2A1A 管理層討論及分析 ® EGFRFOLFIRIRAS/BRAFmCRC®2024618®NMPAmCRCEGFR®mCRC ® (AIS)®20207202012STROKE®IIITASTE®90mRS0-1® IIaB(ESOC)(AHA)(WCN) •20245TASTETASTE-SL(LAA) 管理層討論及分析 •20245(EXPAND)EXPANDAISAISNIHSS •2024630®22%634,800 ® ®20172012®100 •20246(EULAR)5 ® 3CL20211117 •20241(The NewEngland Journal of Medicine)®COVID-19II/ III351,092(95.9%)874(76.7%)®®3CL •20245714 •20247 8®NMPA 管理層討論及分析 NDA ® ®AIS®® •2024219·JAMA NEUROLOGY29.0®IIITASTE-SL®AIS •20248 29®FDABTDAIS®FDABTDFDA® ® Apexigen, Inc.Pyxis Oncology, IncVEGF •20241 3SCORESPFSOS •20243 15®NMPA •20246 2SCORES2024ASCO(1)BIRCPFS(2)VEGFPARPPFS(3)OS(4) BIRCDCRDOR(5) ® IdorsiaDORAAB®®®12®®(EMA)DORA® •20243 15®III205(LPI) •20247 16® 管理層討論及分析 LNK01001 (JAK1)5 LNK01001JAK1(RA)(AS)(AD)3IIJAK20223 18LNK01001 (PA)6 (PA)24 •20242 21III•20244 1(BA)(LPI) (IL-4R)7 IL-4RIL-4RIL-4IL-13IL-4RIL-4IL-13Th2Th2 •20247 8IIIFPI •20247 23IIIFPI 567Rademikibart I/II SIM0270 (SERD) SERDSIM0270SERDSIM0270 IPP2D200 •20247 7CDESIM0270 III(Pre-III) SIM0235TNFR2 G1IgG12TNFR2PD-1SIM0235TNFR2FcTNFR2 SIM0237PD-L1/IL15v PD-L1IL-15/IL15RsushiPD-L1PD1/PD-L1IL-15SIM0237PD-L1IL-15 •20241 23SIM0237FPI 管理層討論及分析 SIM0501USP1 1USP1SIM0501PARPiHRD •20241 10SIM0501NMPASIM0501 •20243 19(FIH) SIM0500GPRC5D-BCMA-CD3 1(BIC) •20243 9SIM0500INDFDASIM0500•2024312SIM0500INDNMPASIM0500•20244 9SIM0500FDA≥3(PI)(IMiD)CD38•20245 24(FIH) SIM0348TIGIT/PVRIG IgG1TIGIT/PVRIGTIGITPVRIGCD155/TIGITCD112/PVRIGSIM0348 SIM0395 (Paxalisib) PI3K/mTORIIPaxalisibMGMT2018PaxalisibFDAGBM2020FDA(DIPG)20213KaziaSIM0395 •20247 10KaziaPaxalisib(SOC)IIIGAM-AGILE2024FDA SIM0278 (IL2 mu Fc) TTregIL2Fc(IL2 muFc)SIM0278TTregTreg2022928Almirall S.A.AlmirallAlmirallSIM0278 SIM0800 (AQP4) 4 (AQP4)First-in-class201910Aeromics, Inc.SIM0800 IND 40(FIC)BIC 管理層討論及分析 SIM0506SOS1 SOS1SIM0506pan-KRAS •2024426SIM0506INDNMPAKRAS SIM0508Pol PolDNAMMEJDNA •20248 22SIM0508INDNMPA•20248 29SIM0508INDFDA SIM0505 (CDH6-ADC) CDH6-IIK-ADC20242025NMPAFDAIND SIM0686 (FGFR2b-ADC) (FGFR)(FGF)FGFR1FGFR2 FGFR3 FGFR4ADC2025NMPAFDAIND SIM0323 (CD80/IL2) GI InnovationFirst-in-class CD80/IL-2PD-12021FDAI/II SIM0802 (PSD-95) AvilexAIS(SAH)PSD-95 20246301(100mg)12.5mgC20H25ClN2O5 20246301991933320246302639828 2023630202311520236 30 202463031.14202333.827.9%(a)i)®ii)®(b)® 6.1919.9%20237.8320.9%9.0929.2%202310.5513.8%8.5027.3%20236.5929.0%7.3623.6%20238.8516.8% 管理層討論及分析 •20246306.1220239.8938.1%19.7%202329.2%9.5•20246305.6620237.7627.0%18.2%202322.9%4.7•20246300.4620232.1378.4%1.5%20236.3%4.8 20246304.5722.7479.9%(a)3DMedicines Inc.20246300.4811.34(b)7.89 — (i)(ii)(iii) 20236303.9420246305.3836.5% 管理層討論及分析 (1) (2)2024(3)2023 20246308.630.822023®202463027.552023123120.073.02202312310.12202463010.032023123112.219.942023123110.15202463010.031.0%2.35% 20246 30209.9%20231231209.9%41.0%2023123133.5%(a)20249.7(b)20246202312314.01 20246300.680.2420246301.1220246302024630 20246 30 20246 30 20241 142,306,500202413120241 1 管理層討論及分析 20242 2497011.45%20242 24 20243205%20243204.43% 2024630 20246306,412202463010.6220215 202021(1)(2)2021 企業管治及其他資料 2024630571XV(i)XV78(ii)352(iii) (1)20246 302,543,785,618 (2)Simcere Investments Group LimitedSIGP&H Holdings Group Ltd.P&H HoldingsRightWealth Holdings LimitedRight Wealth1,801,828,668(i) Artking Global LimitedArtkingSimcere PharmaceuticalHolding LimitedSPHL606,810,031950,431,689(ii) SIGFortune Fountain Investment Limited FFI116,259,578128,327,370(i)164,000(ii)246,000 (3)(i)1,550,000(ii)20212,100,0002,100,000 (4)(i)1,228,333(ii)20211,241,6671,241,667 (5)(i)164,000(ii)2021246,000246,000(iii)1,801,828,668 2024630XVXV78352 2024630XVXV23336 企業管治及其他資料 (1)20246 302,543,785,618 (2)1,801,828,668(i) ArtkingSPHL606,810,031950,431,689(ii) SIGFFI116,259,578128,327,370 (3)P&H Family TrustP&H Family TrustP&HHoldingsP&H Holdings(4)Right WealthRight Wealth(5)(6)(7)Artking606,810,0311,195,018,637(i)ArtkingSPHL950,431,689(ii) SIGFFI244,586,948ArtkingArtking(8)Simcere Holding1,801,828,668(i)Simcere HoldingSPHL950,431,689(ii)851,396,979(a) Artking606,810,031(b) SIGFFI244,586,948ArtkingSIG FFISimcere HoldingSimcere Holding(9)Excel Investments1,801,828,668(i)Excel Investment