先声药业2023中期报告

4 5 7 32 42 43 44 45 48 51 (1)(2) (1) (2) (3)(2) (1)20231 1820233 31(2)20231182023331(3)20233 31 公司資料 183171712–1716 30 53 18343 108 699–18 1333304–3309 http://www.simcere.com 2096 20236 30 •33.79202227.0025.2%•24.1371.4%202217.6736.6%•10.5531.2%20221.5%7.8323.2%202234.8%6.5919.5%202230.0%8.8226.1%202263.0%•7.7620226.521.2419.1%123.0%202224.1%•22.7520220.64•0.8720220.02 公司概覽 2,80017,000200 GMPGMPFDA 20236301410040NRDL (SAB)X TCENKCEAI20236301,000160500 20236304,70032 管理層討論及分析 20232023DRG/DIP 2023630202225.2%71.4%24.13202236.6%®®®®®®®NDA •®20231 13®20232 17®ES-SCLCNMPA20238 14®NMPA®ES-SCLC •®20236 28®AISNDANMPA20237 3®IIFPI20236 30®564,20022% •2023128®COVID-1920232®323062,5002023711®Ib20237 31®NMPA 60NDA2PCC3IND4FPI/FIH5LPI6640 •2023427®ICHNMPAIIICH 管理層討論及分析 •720237 20NMPAI+III20237 28 •20237 27IL-2FcSIM0278NMPA •2023630®®®•20236 7GMPGMP20236 302023 ®NMPAH20230001 20231 28 ®NMPAIIICH 20234 27 ®NDANMPA 60195NDA3I/II1140ADC 管理層討論及分析 202363024.1371.4%33.79202227.0025.2% ® ®20207202012STROKE®IIITASTE®90mRS0-1® (ESOC)(AHA)(WCN) •20234 27®NMPAII20237 3IIFPI 管理層討論及分析 •2023519100®TASTE II®AIS1,30024AIS •202362422019TASTE(AIS)®IIaIIaB •20237 4RWSEXPAND4,750AIS •20236 30®564,20022% ® ®2017CSCONSCLC •20236ASCO®(1)PD-1EGFR/ALKNSCLC(2)ICIsNSCLCNSCLC •20237 42023NSCLC2022 •20237 182023PS0~112A 管理層討論及分析 ® PD-L1Fc20211125NMPA®PD-(L)1PD-(L)12020330 •20231ASCO®(1)CAPEOXMSS(2)TACEIICISLD-12 •20234®CSCOCSCO2023I2ACSCO2023II2ACSCO2023I2ACSCO2023IICSCO2023IICSCO2023III2B •20234 132023CN006MSI-H/dMMR2B •20236ASCO®SOXPD-L1 •20237 3172023®MSI-H/dMMR2B ® 46 (CDK4/6)First-in-classG120208G1Therapeutics, Inc.G1®2021213FDA2022712 ®NMPA(NCCN)CSCO •20231 13®•20232 17®ES-SCLCNMPA•2023510G1IITNBC®ADC50%•20235British Journal of Clinical Pharmacology(IF 3.7)(240mg/m2) 管理層討論及分析 •2023511(ESMO BC)SGmTNBCIISGmTNBC(AEs) •2023525306Frontiersin Pharmacology (IF5.6)Meta(SN)(FN)CIM(G-CSF) •202362~659ASCOTNBCES-SCLCTNBCAC/T+PEA(PEAT)PEAES-SCLCPEAPEAES-SCLC •20237 12023®1 •2023814®NMPA®ES-SCLC ® 1.1®20172012®100 •20233Frontiers in Immunology(add on)(UPCR)1.0(IGU)(LN) •20235 312023EULARRA(OA)RA(ILD)EULAR ® 3CLSARS-CoV-23CL 管理層討論及分析 II/III®11COVID-191.52.4®®596%1.43log10mL2.2®COVID-19 •20231 28®NMPAH20230001(COVID-19) •20232 8•20233 220234 28®COVID-19•2023321105FPI202351637SIM0417I•2023411108FPI202361514SIM0417I •20236 93040,000RWS2,200 •20237 11The Lancet Regional Health – Western PacificCOVID-19Ib750 mg+100 mg •20237 31®NMPA NDA ® ®® •2022121®III(DBL)®AIS®AISAIS 管理層討論及分析 •20236 28®NDANMPA® •20239 6®I6 VEGFIb •2023627IIISCORESLPI53421 DORAABIII12(EMA)DORA20221116Idorsia •2023720NMPA •2023728 I/II SIM0278 (IL2 mu Fc) TTregIL2Fc(IL2 muFc)SIM0278TTregTregSIM0278PKTregTNK20229 28AlmirallAlmirallSIM0278 •2023727SIM0278NMPA •20238 26SIM0278 IFPISIM0278 SIM0395 (Paxalisib) PI3K/mTORIIPaxalisibMGMT2018PaxalisibFDAGBM2020FDA(DIPG)20213KaziaSIM0395KaziaIIIGBM AGILE SIM0270 (SERD) SERDSIM0270SERD 管理層討論及分析 •202323SIM0270NMPA20237 10 •20236 30SIM0270SERD ERHER-2IRP2D(RP2D) SIM0235 (TNFR2) G1IgG12TNFR2PD-1SIM0235TNFR2(ADCC)(ADCP)FcTNFR2TregMDSC(TNF)TNFR2TNFR2TNFR2+TregMDSCSIM0235TNFR2FcTNFR2 •2023313SIM0235PD-1KEYTRUDAR•SIM0235T(CTCL) I296(RD)2023 SIM0272 (PRMT5) PRMT5PRMT5PRMT5SIM0272PRMT510 •SIM0272I25(RD) SIM0237PD-L1/IL15v PD-L1IL-15/IL15RsushiPD-L1PD1/PD-L1IL-15SIM0237PD-L1IL-15 •20233 8SIM0237IFPISIM0237MRCT•20237 24SIM0237INDNMPA SIM0348TIGIT/PVRIG IgG1TIGIT/PVRIGTIGITPVRIGCD155/TIGITCD112/PVRIGSIM0348FcTIGITTIGITPVRIGTregNK •2023329SIM0348IFPI SIM0801 (QPCT) QPCTQPCTN3pESIM080120216VivoryonTherapeutics N.V.SIM0801202112FDA(Fast Track) 管理層討論及分析 •SIM0801NMPA(AD)(MCI)III SIM0800 (AQP4) 4(AQP4)First-in-class201910Aeromics,Inc.SIM0800 •20232 25SIM0800II SIM0335IL-17A IL-17ASIM0335(CKBA)I •2023112SIM0335IIaSIM0335 •20233 250% IND enablingFICBIC SIM0323 (CD80/IL2) GI InnovationFirst-in-class CD80/IL-2PD-12021FDAI/II SIM0419 (PSD-95) AvilexAIS(SAH)(AVLX-144)PSD-95PSD-95N--D-NMDAnNOSSIM0419PSD-95PSD-95PDZPSD-95NMDAnNOS SIM0500 (GPRC5D-BCMA-CD3) 1GPRC5D/BCMA/CD3best-in-classSIM0500TCD3TSIM05002023NMPAFDAIND SIM0501USP1 USP1USP1PARPDNADDRUSP1HRDPARPUSP1iPARPiDNAHRDBRCAPARPiPARPi2023NMPAFDAIND 管理層討論及分析 SIM0506SOS1 SOS1SOS1KRASGTPRASGDPKRASSIM0506pan-KRASKRASMEKKRASERKMEKKRAS2023NMPAIND SIM0508Pol PolDNAMMEJDNA(HRD)MMEJDNAPARPHRDPolPARPHRDDNADDRPolPolPARPHRD2024NMPAFDAIND 202363030.1gC32H31BrN2O2(0.8g)16.7ml0.3g15ml:0.25mgC19H24N2O5mgC16H20N6O 2023630158153520236302348221 COVID-19 20231 8COVID-193CL®2023128 COVID-19COVID-19®COVID-19COVID-19 管理層討論及分析 202363022.7520220.64(a)3D Medicines Inc.202212312023630202363011.4920223.31(b) 20237.89(c)2023 202363024.462022123116.580.11202212319.7520236309.10202212 3112.924.602022123112.924.502022123120236301.0%2.70%202363028.7%202212 3133.7% 20236301.690.1820236 30 20226200 20236 30 20236 305% 1244202363040.023,047,4689.00%202363020.5520236 3016.2% 202363011.342023330