君实生物2024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 2474258596163646692 123 2618 25Roy Steven Herbst71 4 56Roy Steven Herbst78 1112 910 1112 36582101003 58 163485 985,689,871219,295,700H766,394,171A 68 H200H H 1617 • H01877A688180 www.junshipharma.com 12024112202462122024112202462132024228420246215202462162024621720246218202462192024621102024621112024424122024424 •2024630786202317%202311%®671202350% •546202342%®•646202335135%•20246303,31120231231467 •(ADCs)3®®®3020 202412023®36®COVID-19®8 20241CoherusLOQTORZI®202310FDA202312NCCN 20241HSA 20244PMDAtifcemalimabBTLATAB004/JS004(LS-SCLC)III 20244PCSK9JS002sNDANMPA 20244®sNDANMPA 20244DO 20246®IIIHEPATORCHNCT04723004PFSOSsNDA20247NMPA 20246®(ES-SCLC)sNDANMPA 20246®P D - L1CPS≥1TNBCsNDANMPA • GMPEC 2024620232024A2024H first-in-classbest-in-class®LOQTORZI®JS001NMPAPD-110sNDAFDAtifcemalimab(first-in-human)BTLAFDANMPAIND2IIIIb/II (ADCs)202478617%®50% ®67150%® 2024®36PD-1®10 NMPA36 ®NMPANMPA®sNDANMPA 20244®NMPA 20244DO 20246®IIIHEPATORCHNCT04723004PFSOS20247®sNDANMPANMPA36 20246®(ES-SCLC)sNDANNPA 20246®PD-L1CPS≥1(TNBC)sNDANMPA 20248®sNDANMPA 202310FDA20241Coherus33NCCN (Project Orbis)TGAHSATGAHSA 20247EMACHMPECCHMP MHRA HikmaDr.Reddy’s50 20244PMDAtifcemalimab(LS-SCLC)I I IJ U S T A R -001NCT06095583BTLA17190756(FPI) cHLtifcemalimabcHLIII(NCT06170489)tifcemalimabBTLAIIItifcemalimabPD-(L)1cHL50185 tifcemalimabIb/II 20244sNDANMPANMPA IL-17AJS005III Claudin18.2ADCJS107PI3K-αJS105CD20/CD3JS203PD-1/VEGFJS207DKK1JS015 2NMPAGMP4,5009*50020235FDAPre-LicenseInspectionPLIEMA20247(TheIrelandHealthProducts Regulatory Authority)EMACERTIFICATE OF GMP COMPLIANCE OF AMANUFACTURERGMPGMPGMPGMP 42,00021*2,000NMPA EMAGMPMAH 2,532652 (license-in)(ADCs)3®®®3020 ®TAB001/JS001 • ®67150%PD-1FDA2 10 •201812•20212•1220214•202111•20225 •EGFRALK20229•IIIA-IIIB202312•20244•(ES-SCLC)20246•PD-L1CPS≥1(TNBC)20246 ®sNDANMPA20244(DO)®CSCOCSCOCSCOCSCOCSCOCSCOCSCOCSCO 20241®36PD-1®® ® 2023102024120247(CHMP)(EC)CHMP(MHRA)(TGA)(HSA) • 1540 20244®sNDANMPA 20244DO 20246®IIIHEPATORCHNCT04723004PFSOS20247®sNDANMPA 20246®(ES-SCLC)sNDANMPA 20246®P D - L1CPS≥1(TNBC)sNDANMPA 20248®sNDANMPA 20241HSAHSA 20247CHMPECCHMP 20241(nab-P)IV(TNBC)IIITORCHLIGHT(NatureMedicine ,IF=58.7)TORCHLIGHT2023ASCO(LBA)nab-PPFSPD-L1IVTNBC 20241(GC/GEJC)II(NEOSUMMIT-01)(Nature MedicineIF=58.7)2023ASCO 20241(NSCLC)IIINEOTORCH(Journal of the American MedicalAssociationJAMAIF=63.1)JAMANEOTORCH2023ASCO(ASCOPlenarySeries)4ASCOEFS 20241S C A L E -1(ChiCTR2100045104)(Journal forImmunoTherapy of Cancer , JITC, IF=10.3) 20241II(Nature )(Nature Communication ,IF=14.7)(ORR)95.7%56.6%(CR)12PFS95.7%82.4%4-5(TRAE)0 20241IIINSIGHTClinical Cancer ResearchIF=10.0 20242II(ESMO)AnnalsofOncologyIF=56.733.3%(RFS)11.7 20243IIDNA(ctDNA)(bTMB)NatureCommunicationIF=14.7•(The Lancet Oncology , IF=41.6) 20243(nCRT)(ESCC)Journal For Immunotherapy Of CancerJITCIF=10.3PD-1ESCCnCRTESCC(MPR)78.9%(pCR)47.4%nCRTESCC 20244POLARIS-015TheOncologistIF=4.8POLARIS-01PD-1Clinical Cancer ResearchIF=10.0POLARIS-01(DOR)15.6(OS)2060OS28.5% 20246(HCC)II(Clinical Cancer Research ,IF=10.0)HCCRECISTv1.1ORR31.5%PFS8.5IRCmRECISTORR46.3%PFS9.8HCC2022ASCO GI 20246(RCC)IIJournal For Immunotherapy Of CancerJITCIF=10.32024(AUA)PD33-07 20246302024ASCO(I-O)I-O TifcemalimabTAB004/JS004 Tifcemalimab(first-in-human)BT(BTLA)BTLABTLATBBTLAHVEMHerpes virus entry mediator2005HVEMTNFBTLATifcemalimabBTLAHVEM-BTLABTLA TifcemalimabIIIIb/II • tifcemalimabIII J U S T A R - 0 0 1I I Itifcemalimab(LS-SCLC)BTLA17190756(FPI) JS004-009-III-cHL(NCT06170489)IIItifcemalimabPD-(L)1(cHL)BTLAIII50185 tifcemalimabIb/IItifcemalimab Tifcemalimab(R/R) 2024ASCOtifcemalimab(ES-SCLC)I/II#8089Ib/II(NCT05664971)tifcemalimabES-SCLCtifcemalimab(200mgQ3W)(240mg,Q3W)+4tifcemalimab143tifcemalimabORR86.0%DCR100%(DoR)4.3PFS5.4(OS)297.7%(TEAE)≥3TEAE88.6%(irAE)29.5%tifcemalimabES-SCLC 2024ASCOtifcemalimabI#259616tifcemalimab(20mg70mg 200mg500mgQ3W)(240mgQ3W)75(RCC)(NSCLC)(UC)5tifcemalimab(200mgQ3W)(240mgQ3W)475.8%PD-(L)118ORR17%DCR39%RCC11ORR18%, DCR73%NSCLC17ORR6%, DCR42%UC9ORR11%DCR22%tifcemalimab(IO)tifcemalimab2022ASCOtifcemalimab ®JT001/VV116 ®RdRpRdRp®® 2023128®NMPACOVID-19®2023120241 ®®®®®®2,300 ®UBP1211 ®®20223®NMPA20225202211®NMPA®55®262431,303 JS002 PCSK92III1II1IIIIII 20244sNDANMPANMPA 2 0 2 45I I IJS002-006(Nutrition Metabolism AndCardiovascularDiseases )20246IIIJS002-003(Journal of the American Heart Association ) IL-17AJS005 JS005IL-17AJS005IL-17JS0052023(ACR)JS005Ib/IIJS005JS005(p<0.0001)JS005III PD-1VEGFJS207 JS207PD-1VEGFVEGFPD-1JS207PD-1VEGFAPD-1PD-L1PD-L2VEGFVEGFPD-1VEGFJS207JS207JS207JS207I CD20CD3JS203 JS203CD20CD3CD20BBCD3TCD3TTJS203CD20CD3TCD3CD20TJS203JS203JS203I PI3K-αJS105 JS105PI3K-α(HR)-2(HER-2)PIK3CAJS105JS105JS105I/II Claudin18.2-MMAEJS107 JS107Claudin18.2-MMAE(Monomethy lauristatin E)Claudin18.2(ADCs)JS107Claudin18.2MMAEJS107(ADCC)(CDC)MMAEJS107JS107JS107I/II 1. 2024630786202317%(i)709202311%®(ii)5