君实生物2024年度报告

(於中華人民共和國註冊成立的股份有限公司)股份代號:1877 2024年度報告 24111459718891113117119121123126228 12143 15511 2155111 4 1556789Roy Steven Herbst1011 2141589Roy Steven Herbst101 1213 1617 6911 1617 9874 985,689,871219,295,700H766,394,171A H200H 16 33191918 www.junshipharma.com H 1617 • H01877A688180 120241122024621220241122024621320242284202462152024621620241220720241220820241220920246212024102310202462111202462112202462113202462114202412201520241220162024424172024424 •202412311,948202330%®1,501202366%•1,275202334%®•1,282202399944%•202412312,917 •(ADCs)4®®®®3020 20241CoherusLOQTORZI®202310FDANCCN2025.V1 20241HSA20253LOQTORZI®HSA 20244PMDAtifcemalimabBTLATAB004/JS004(LS-SCLC)III 20244®sNDANMPA 20244DO202410PPB 20246®IIIHEPATORCHNCT04723004PFSOSsNDA20247NMPA20253NMPA 20246®(ES-SCLC)sNDANMPA 20246®P D - L1CPS≥1(TNBC)sNDANMPA 20247JS125HDACsINDNMPA20249NMPA 20247LOQTORZI®EMACHMP20249EC27PD-L1 20248®sNDANMPA 202492024112024 202410PCSK9®NMPA 202411LOQTORZI®MHRAPD-L1 202411®4®10PD-1 • 2024620232024A2024H 20247HPRAEMACERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURERGMPGMPGMPGMPGMP 20248A30 20249A815,871A0.0828% 202412AA500500 20251®NMPA20251JS212EGFRHER3ADCINDNMPA20253NMPA20251®COVID-19NMPA20251TGA20251TopAllianceTopAllianceTopAlliance1,50020252JS213PD-1IL-2INDNMPA 2024 202419.4830%®15.0166% 202432023202435PD-1(CSCO)(NCCN)(ESMO)PD-1 2024®NMPA T i f c e m a l i m a bJ S 2 0 7f i r s t - i n - c l a s stifcemalimabBTLAIIIJS005IL-17AIIIPD-1/VEGFJS207II/IIIClaudin18.2ADCJS107PI3K-αJS105CD20/CD3JS203DKK1JS0152025 GMP42,000 2025ESG 2025327 first-in-classbest-in-class®LOQTORZI®JS001NMPAPD-111sNDAFDAtifcemalimab(first-in-human)BTLAIIIIb/II2025 2024®NMPA36922,1001451,20010015 (ADCs)20241,94830%®66%2,917 2024®1,50166%® ®1120241®32023202411®4202410PD-1202511 ®NMPANMPA®11sNDANMPA 20244®NMPA 20244DO202410PPB 20246®IIIHEPATORCHNCT04723004PFSOS20247®sNDANMPANMPA3620253sNDANMPA 20246®(ES-SCLC)sNDANMPA 20246®PD-L1CPS≥1(TNBC)sNDANMPA 20248®sNDANMPA 20251®NMPA LOQTORZI®202310FDA20241NCCN2025.V1 20241HSAHSA20253LOQTORZI®HSA(Project Orbis)FDA(OCE)FDA 20247LOQTORZI®CHMP20249EC27PD-L1 202411LOQTORZI®MHRAPD-L1 202492024112024 20251TGA(Project Orbis)TGA 20251TopAllianceTopAllianceTopAlliance1,500 27HikmaDr.Reddy’s80 20244sNDANMPA202410NMPA BTLAtifcemalimabTAB004/JS004IL-17AJS005PD-1/VEGFJS207 BTLAtifcemalimabIII Tifcemalimab(LS-SCLC)IIIJUSTAR-001NCT06095583BTLA1719075615150 T i f c e m a l i m a bc H LI I I(NCT06170489)BTLAIIItifcemalimabPD-(L)1cHL60185 JS005III JS207II/IIIJS207-003-II/III-SCLC20253NMPA INDNMPA 20247JS125HDACINDNMPA20249NMPA20251JS125JS20720251JS212EGFRHER3ADCINDNMPA2025320252JS213PD-1IL-2INDNMPA IClaudin18.2ADCJS107PI3K-αJS105CD20/CD3JS203DKK1JS0152025 24,5009*5002023520243FDAPre-License InspectionPLIEMA20247HPRAEMACERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURERGMPGMPGMPGMPGMP42,00021*2,000NMPAGMP EMAGMPMAH 2,578620 202452% (license-in)(ADCs)4®®®®3020 ®TAB001/JS001 • ®1,50166%PD-1FDA 11 •201812•20212•1220214•202111•20225•EGFRALK20229•IIIA-IIIB202312•20244 •(ES-SCLC)20246 •PD-L1CPS≥1(TNBC)20246 •20253 202410®sNDANMPA(CSCO)(NCCN)(ESMO)PD-1 202511®410PD-1®® ® 2023102024127HikmaDr.Reddy’s80 • 1540 20244®sNDANMPA 20244DO202410PPB 20246®IIIHEPATORCHNCT04723004PFSOS20247®sNDANMPA20253NMPA 20246®(ES-SCLC)sNDANMPA20246®P D - L1CPS≥1(TNBC)sNDANMPA20248®sNDANMPA20251®NMPA 20241HSA20253LOQTORZI®HSA 20247LOQTORZI®CHMP20249EC27PD-L1 202411LOQTORZI®MHRAPD-L1 202492024112024 20251TGA 1451200JAMANatureMedicine 202452024119(AUA)2024(ESTRO) 20246302024ASCO(I-O)I-O 202492024(WCLC) 20249182024(ESMO) 20249272024CSCO7 2024106202466(ASTRO) 202410(SCRT)IITORCH-E202443(ESSO) 202412(ESMOASIA)(ESMOI-O) 20251I/II2025(ASCOGI)#4232024ASCO GI 202522025(ASCOGU) 20252(OCCC)II202526(ESGO)#381 20241(nab-P)IV(TNBC)IIITORCHLIGHTNatureMedicineIF:58.7TORCHLIGHT2023(ASCO)(LBA)nab-PPFSPD-L1IV 20241(NSCLC)IIINEOTORCHJournalof the American MedicalAssociationJAMAIF:63.1JAMANEOTORCH2023ASCO(ASCOPlenarySeries)4ASCOEFS 20247T O R C HC A P O XIIJournalof ClinicalOncologyJCOIF:42.1TORCH(iTNT)(W&W)pMMR/MSS(LARC)iTNTAB50%(CR)80% 20247HER2II(NCT04389073)NatureMedicineIF:58.7HER2VEX++DCRPFS 20248IIIHCHTOG1909(NCT04280822)CancerCommunicationsIF:20.1(ESCC)+OSpCRR0MPRESCC 20249(NSCLC)IIICHOICE-01CancerCellIF:48.8CHOICE-01ctDNAblood-based genomic immune subtypesbGISNSCLC 20249+EP(SCLC)Ib/IISignalTransductionand Targeted TherapySTTTIF:40.8EP(ES-SCLC)ORR97.1%DCR100%(mPFS)6.9(mOS)21.1SCLC2022(ESMO-IO)2023ESMO-IO 202410IINEOTAXSignalTransduction and Targeted Therapy STTTIF:40.8NEOTAX(RCC)44.0%2024ESMO 202411(ES-SCLC)IIIEXTENTORCH•(JAMA OncologyIF:22.5ES-SCLCPD-1IIIEXTENTORCHSCLC2023(ESMO)LBA 202412IILancetOncologyIF:41.660%≥3 TifcemalimabTAB004/JS004 Tifcemalimab(first-in-human)BT(BTLA)BTLABTLATBBTLAHVEMHerpes virus entry mediator2005HVEMTNFBTLATifcemalimabBTLAHVEM-BTLABTLA TifcemalimabIIIIb/II • JUSTAR-001IIItifcemalimab(LS-SCLC)BTLA1719075615150 JS004-009-III-cHL(