君实生物2023中期报告

(於中華人民共和國註冊成立的股份有限公司)股份代號:1877 2023中期報告 2484057586062636597 Roy Steven Herbst23 1 Roy Steven Herbst23 36582101003 163485 985,689,871219,295,700H766,394,171A H200H H 1617 • H01877A688180 www.junshipharma.com 120238302202363032023630 •2023630670202229%®447202250%®110•949202211%•996202285 •(ADCs)3®®®3020 20231(SARS-CoV-2)1®JT001/VV116NMPACOVID-19 20232MHRA20233JS010CGRPINDNMPA20234®IIIsNDANMPA20234PCSK9JS002NDANMPA20234JS401ANGPTL3 mRNAsiRNAINDNMPA20235®PD-L1CPS≥1sNDANMPA2023620238tifcemalimabBTLATAB004/JS004IIIINDFDANMPA20236JS207PD-1VEGFINDNMPA20237®sNDANMPA20237®sNDANMPA® 20233ExcellmabExcellmab40%ExcellmabExcellmab452 20235Dr. Reddy’sDr. Reddy’sDr.Reddy’s9 • 202362022GDR(SIX Swiss Exchange)34 2023620072008 first-in-classbest-in-classJS001®NMPAPD-16tifcemalimab(first-in-human)BTLAFDANMPAIII2020COVID-19(JS016)VV116/JT001® (ADCs) 6.25103%®4.4750%®1.10®6,800 ®®®2022 ®®20231NMPA202341®2,200®2023®® ®®6,80025202367172955 ® NMPA®®sNDANMPA 20234®IIIsNDANMPA20235®PD-L1CPS≥1sNDANMPA20237®sNDANMPA20237®sNDANMPA® FDAEMAMHRA 20234NDANMPAIIIIIIII 2023620238FDANMPABTLAtifcemalimabTAB004/JS004III756IIItifcemalimabIb/II2023642023ASCO#8579tifcemalimabI/II202331426.420(I-O)tifcemalimabORR40.0%95%CI 19.1-63.9DCR70.0%95%CI45.7-88.1DoR6.995%CI1.4-6.93(15.0%)DoR6PFS5.595%CI1.4-6.4 IL-17AJS005IIIII CoherusHikma Dr.Reddy’s50 20233ExcellmabExcellmab40%ExcellmabExcellmab452 20235Dr. Reddy’sDr. Reddy’sDr. Reddy’s9 2GMP4,5009*500CGMP42,00021*2,000NMPA 2,772854 (license-in)(ADCs)3®®®3020 ®TAB001/JS001 • ®PD-12®620181220212122021420211120225EGFRALK20229sNDANMPA®CSCOCSCOCSCOCSCOCSCOCSCOCSCO ®4.47®®2022 1540 20231®IIINeotorchNCT04158440IDMCEFS20234®IIIsNDANMPA 20232®IVIIITORCHLIGHTNCT04085276IDMC20235®PD-L1CPS≥1sNDANMPA 20234®IIIRENOTORCHNCT04394975IDMCPFS20237®sNDANMPA 20235®IIIEXTENTORCHNCT0401260620237®sNDANMPA 20236®GEMOXGEMOX(ICC)III(NCT05342194) 20232(MAA)MHRA 20235FDAPre-License InspectionPLI 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)ASCO NeotorchEFS60%Neotorch(NCT04158440)III404IIIPD-1EFSIII C H O I C E - 0 1O SO S2 7 . 8CHOICE-01(NCT03856411)PD-1III465EGFR/ALKJournalofClinical OncologyIF45.3 JUPITER-02OS3OS64.5%JUPITER-02(NCT03581786)III289 PD-1(TRG0/1)44.4%PD-1(TRG 0/1) ®JT001/VV116 ®RdRpRdRp®® 2023128®NMPACOVID-19III(NCT05582629)®COVID-1928SARS-CoV-21,277®11COVID-19=022COVID-19 ®1.10®20231202341®2,200®2023®® TifcemalimabTAB004/JS004 Tifcemalimab(first-in-human)BT(BTLA)BTLATifcemalimabIIIIb/II2023642023ASCO#8579tifcemalimabI/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 2023620238FDANMPAtifcemalimabIIIBTLA756 ®UBP1211 ®®20223®NMPA20225202211®NMPA®6,80025202367172955 JS002 PCSK9IIIIIIII 20234NMPANDA(1)(2)12 IL-17AJS005 JS005IL-17AJS005IL-17JS005JS005IIIII PD-1JS207 JS207PD-1VEGFVEGFPD-1JS207PD-1VEGFAPD-1PD-L1PD-L2VEGFVEGFPD-1VEGFJS207JS207JS20720236JS207INDNMPA ANGPTL3 mRNAsiRNAJS401 JS401ANGPTL3mRNAsiRNAANGPTL3(LPL)(EL)ANGPTL3JS401N(GalNac)ANGPTL3mRNAANGPTL3ANGPTL3Evkeeza®(Evinacumab-dgnb)siRNA20234JS401INDNMPA CGRPJS010 JS010PD-1CGRPJS010CGRPCGRP37α-CGRPβ-CGRP CGRPCGRPJS010α-CGRPβ-CGRPJS010α-CGRPβ-CGRPcAMPJS010JS0108CGRP20233JS010INDNMPA 1. 2023630670202229%6412022108%®®®®447202250%®68®110 2. 949202211311%62023164925202217%69%20226%25%22% 3. 37320226621%204149119202210%43%41%202276% ®® 4. 24220225318%1065649526202221%13%70%30%20229% (i)(ii) 5. 2023630202212315,9974,8541,228160220 6. 20232A2,818,2312023222023630 20226302022624 2023630 451502022123160 (a)(b)2022123130(c) 09020221231090 202320226301231 20236305502.0% 202363020236307843.5%3.9% iiiiii 2023630 20236301,5552022123193566% GDR3,40020237,700 100%2023630 2023630 2020A 20209292020A2020A2020111620202020A2020H 2020A2020A (a)2020A (b)202011162020A1,93328,519,000 (c)2020A2020111620202020A2020H1212 (d)2020A35,648,000AA4.65%3.62%2020A7,129,000A20%A (e)1% (f)2020A2020111648 (g) (1)40%1224(2)30%2436(3)30%3648 (1)50%1224(2)50%2436 (h)A55.50AA55.50 (i)2020AA2020929A50%A85.46(ii)2060120A50%20A90.25 A2020715A55.50 (i)2020A (j) 20231120236302020A2020A20236302,818,231202322 2020A (1)20201116 (2)(1)40%1224(2)30%2436(3)30%3648 2023830 2020A (1)20211115(2)(1)50%1224(2)50%2436(3)A55.50(4) 24 2020A20201022202011162020111720211115202211320221116202323 A17,127,980AA2.24% 20236306596 14725 2023830 Roy Steven Herbst20236302023630 3 13.51B(1) 202213.51B(1) 2023630XVXV78352 1.LSP2 0 2 363 0985,689,871766,394,171A219,295,700H 2.202363087,854,018A2,600H2020A492,000 (i)201712252017202112312017108,297,768A41,060,000A(ii)201972620192023630201921,680,800A 2023630( i )20%4,372,144A2017(ii)40%4,600,00043,584,000A201786.28%52,556,144A 3.2