君实生物2023年度报告

股份代號:1877 2023年 度 報 告 241012486178131153157159161163166270 1234 56 Roy Steven Herbst78 Roy Steven Herbst78 36582101003 985,689,871219,295,700H766,394,171A H200H 163485 www.junshipharma.com H 1617 • H01877A688180 1202411222024112320231020420231020202422852023831620238307202363082023630 •202312311,50320223%202258%®919202225% •1,937202219%•2,2822022104 •(ADCs)3®®®3020 20231(SARS-CoV-2)1®JT001/VV116NMPACOVID-19 20232MHRA 20233JS010CGRPINDNMPA 20234®IIIA-IIIBsNDANMPA202312 20234PCSK9JS002NDANMPA 20234JS401ANGPTL3 mRNAsiRNAINDNMPA 20235®PD-L1CPS≥1sNDANMPA 202368tifcemalimabBTLATAB004/JS004IIIINDFDANMPA 20237®sNDANMPA 20237®sNDANMPA® 20238JS207PD-1VEGFINDNMPA 20239III(NCT03430297)PFS 202310LOQTORZI™BLAFDAFDA 202312TGATGA 202312®®®36PD-1®COVID-19 • 20233ExcellmabExcellmab40%ExcellmabExcellmab452 20235Dr. Reddy’sDr. Reddy’sDr.Reddy’s9 202350first-in-class 2023LOQTORZI™FDACoherusHikma Dr Reddy’s50 20233®®®®7610®®8 first-in-classtifcemalimabBTLA2III1PCSK9JS005IL-17AIII 3COVID-1920231® FDAEMAGMP2023 2024328 first-in-classbest-in-classJS001®LOQTORZI™NMPAPD-17FDAtifcemalimab(first-in-human)BTLAFDANMPAINDIII2020COVID-19(JS016)® (ADCs) PD-1FDA 202310LOQTORZI™BLAFDAFDA 202312National Comprehensive Cancer NetworkNCCN2024.v2NCCN 20241Coherus (Project Orbis)TGAHSATGAHSA EMAMHRA HikmaDr.Reddy’s50 ®®2024®36PD-1®® ®®2023120241®2,300®®® ®®261731,316 NMPA®®sNDANMPA 20234®IIIA-IIIBsNDANMPA202312 20235®PD-L1CPS≥1sNDANMPA20237®sNDANMPA20237®sNDANMPA®20239®III(NCT03430297)PFS 2023620238FDANMPABTLAtifcemalimabIII756III cHLtifcemalimabcHLIII(NCT06170489)tifcemalimabBTLAIIItifcemalimabPD-(L)1cHL50185 tifcemalimabIb/II 20234NDANMPA2III1II1IIIIII IL-17AJS005III Claudin18.2ADCJS107PI3K-αJS105ANGPTL3siRNAJS401CGRPJS010CD20/CD3JS203PD-1/VEGFJS207PD-1JS001sc 2NMPAGMP4,5009*50020235FDAPre-LicenseInspection PLI42,00021*2,000NMPA 1212FDAPLIMAH 2,568736 (license-in)(ADCs)3®®®3020 ®TAB001/JS001 • ®PD-1FDA2®720181220212122021420211120225EGFRALK20229 IIIA-IIIB202312®sNDANMPA®CSCOCSCOCSCOCSCOCSCOCSCOCSCO ®919202225%®2024®36PD-1®® 1540 20231®IIINEOTORCHNCT04158440IDMCEFS20234®IIIsNDANMPA202312IIIA-IIIBNMPA 20232®IVIIITORCHLIGHTNCT04085276IDMC20235®PD-L1CPS≥1sNDANMPA 20234®IIIRENOTORCHNCT04394975IDMCPFS20237®sNDANMPA 20235®IIIEXTENTORCHNCT0401260620237®sNDANMPA 20236®GEMOXGEMOXIII(NCT05342194) 20239IIIMELATORCHNCT03430297)PFS 20232(MAA)MHRA 202310BLAFDAFDA 202312NCCN2024.v2 202312TGATGA 20241HSA • 20233GEMOXIINatureSignalTransductionand Targeted Therapy, STTT , IF39.3 20234II(EC-CRT-001)•TheLancet Oncology ,IF 51.1PD-1 20234Cancer CellIF50.3JUPITER-06Esophagealcancer Genome-based Immuno-oncology Classification (EGIC)PD-1+ 20236262023ASCO515610 TORCHLIGHT35%IVIIITORCHLIGHT(LBA)ASCO20241Nature Medicine , IF82.9 NEOTORCHEFS60%NEOTORCH(NCT04158440)III404IIIPD-1EFSIII20241(Journal of the American Medical Association , JAMA , IF 120.7) C H O I C E - 0 1O SO S2 7 . 8CHOICE-01(NCT03856411)PD-1III465EGFR/ALKJournalofClinical OncologyIF45.3 J U P I T E R -02O S3O S64.5%J U P I T E R -02(NCT03581786)III289202311Journal of the American Medical Association, JAMA , IF120.7 NEOSUMMIT-01PD-1(TRG 0/1)44.4%PD-1(TRG0/1)20241Nature Medicine , IF82.9 20239Signal Transduction and Targeted Therapy, STTT , IF39.3GEMOXII(NCT03951597) 202310112023(ESMO)1Late-breaking AbstractsLBA2(Proffered Paper Session)8 RENOTORCH2023331RENOTORCH(NCT04394975)(RCC)PFS(BICR)PFS18.0 vs. 9.835%(HR=0.65;95%C1:0.49-0.86)P=0.0028PFSORRESMOAnnals of Oncology , IF50.5 EXTENTORCH20235EXTENTORCH(ES-SCLC)IIIOSPFSPD-1ES-SCLCPFSOS 20231272023(ESMO-IO)2023(ESMOASIA)115 ®JT001/VV116 ®RdRpRdRp®® 2023128®NMPACOVID-19III(NCT05582629)®COVID-1928SARS-CoV-21,277®11COVID-19=022COVID-19 ®2023120241®2,300®®® TifcemalimabTAB004/JS004 Tifcemalimab(first-in-human)BT(BTLA)BTLATifcemalimabIIIIb/II • 2 0 2 3642 0 2 3A S C O# 8 5 7 9tifcemalimabI/II202331426.420I-OtifcemalimabORR40.0%95%CI:19.1-63.9DCR70.0%95%CI:45.7-88.1DoR6.995%CI1.4-6.93(15.0%)DoR6PFS5.595%CI1.4-6.4 20231265American Society of HematologyASHtifcemalimabR/RI#4458R/RtifcemalimabPD-1ORR37.0%DCR80.4%PD-1/L1(cHL)ORR35.3%DCR85.3%PFS16.2 • tifcemalimabIII 2023620238FDANMPAtifcemalimab(LS-SCLC)IIINCT06095583JUSTAR-001BTLAtifcemalimabLS-SCLC15180756(FPI) 202312tifcemalimabcHLIII(NCT06170489)tifcemalimabBTLAIIItifcemalimabPD-(L)1cHL50185 tifcemalimabIb/IItifcemalimab ®UBP1211 ®®20223®NMPA20225202211®NMPA®261731,316 JS002 PCSK92III1II1IIIIII 20234NMPANDA(1)(2)12 202311III2023(AHA)#3207150mg2300mg4LDL-CLDL-C52(TEAE) IL-17AJS005 JS005IL-17AJS005IL-17JS005JS005III 2023(ACR)JS005Ib/IIJS005JS005(p<0.0001)II12JS005PASI7575%JS005 150mg vs. JS005 300mg vs.95.8% vs 89.4% vs. 8.3%p<0.000112JS005PASI 9077.1% vs 74.5% vs. 4.2%p<0.0001 PD-1VEGFJS207 JS207PD-1VEGFVEGFPD-1JS207PD-1VEGFAPD-1PD-L1PD-L2VEGFVEGFPD-1VEGFJS207JS207JS20720238JS207INDNMPA20239JS207 ANGPTL3 mRNAsiRNAJS401 JS401ANGPTL3mRNAsiRNAANGPTL3(LPL)(EL)ANGPTL3JS401N(GalNac)ANGPTL3mRNAAN