君实生物：截至2025年12月31日止年度的全年业绩公告

SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 1877 20251231 2025123120241231 •202512312,498202428%®2,068202438% •1,38420249%•841202444134%•2,2322025620H940•202512313,195 •ADC4®®®®III 20251®NMPA 20251JS212EGFR3HER3INDNMPA20253NMPA202511JS212INDNMPA202512JS212INDFDA 20251®COVID-19NMPA 20251TGA 20252JS213PD-1-2IL-2INDNMPA 20253®sNDANMPA 20253NDAHSA 20254®sNDANMPA12 20255PCSK9®1HeFH2sNDANMPAPCSK9 20256JT118JT118IND20259NMPAJT118A35M1 20256 20258®HER2HER2HER21+2+3+sNDANMPA 202592025102 202510JS207PD-1VEGFII/III(AGA)II/IIIINDFDA 202511 202511JS001sc®III 202512JS005IL-17ANMPA 202512®2®2025 202512 • 20251TopAlliance Biosciences Inc.LEO Pharma A/S(EU)(EEA)1,500 • 20256FDACGMPUnannounced Inspection 20256HH25.354,100H1,026 202592025A2025H first-in-classbest-in-class(ADC) ®LOQTORZI®JS0011240IIIPD-1/VEGF(JS207)EGFR/HER3ADC(JS212)PD-1/IL-2(JS213) 20252,49828%2,30140%®38%20256H1,0263,195 2025 2,06838%®40 ®2025®(HeFH)sNDANMPA 4®®®®®12PD-1®2025PCSK9 20259®® 2,0002401,250145 AI90 III (first-in-human)BTLAtifcemalimab(LS-SCLC)IIIJUSTAR-001NCT06095583BTLA75615200560 ®JS001scPD-1202511JS001sc®III20263JS001sc12NMPA® 20259JS005IL-17AIII202512JS005NDANMPA J S 1 0 7C l a u d i n 1 8 . 2A D CClaudin18.2III PD-1/VEGF(JS207)EGFR/HER3 ADC(JS212)PD-1/IL-2(JS213) JS207IIADCJS207JS212II202510JS207II/III(AGA)II/IIIINDFDA 20251JS212INDNMPA20253202512JS212INDFDAJS212JS212I/IIJS207JS212II 20252JS213INDNMPAJS213I Coherus BioSciences, Inc.CoherusHikma MENA FZEHikmaDr.Reddy’s Laboratories LimitedDr. Reddy’sRxilient Biotech Pte. Ltd.8040 2 4,5009*500GMP 42,00021*2,000NMPAGMP 20256FDACGMP202510CGMP2023FDAFDA FDAQPGMP(MAH) 2,903640 2025 (license-in)4®®®®(ADC) ®LOQTORZI®JS001 • ®2 , 0 6 838%PD-1FDA 12 •201812•20212•1220214•202111•20225•EGFRALK20229•IIIA-IIIB202312•20244•(ES-SCLC)20246•PD-L1CPS≥1(TNBC)20246•20253•20254 (CSCO)(NCCN)(ESMO)PD-12025CSCOI ®12PD-1®®® 40CoherusHikma Dr. Reddy’s80 • 1540 20251®NMPA20253®sNDANMPA20254®sNDANMPA20258®HER2HER2HER21+2+3+sNDANMPA 20251TGA 20253HSA 20256 202592025102 202511 202512 20262 • 2101,100(JAMA)(NEJM)(ASCO)(ESMO) PD-1VEGF(JS207) JS207PD-1VEGFJS207PD-1VEGFAPD-1PD-L1PD-L2VEGFJS207VEGFT JS207PD-1JS207PD-1FabPD-1VEGFPD-1/PD-L1VEGFPD-1/PD-L1VEGFPD-1NFAT • 20256JS207Frontiers in ImmunologyJS207JS207PD-1VEGFA 202512JS207(FIH)JS207-001-I2025(ESMOAsia)#1166PJS20720mg/kg Q3WPD-L1JS207 10mg/kg15mg/kgORR56.3%60.0%PD-1/VEGFPD-L1JS20715mg/kg20mg/kg10mg/kg≥3TRAE≥35.7%2.9%1-2JS207II(RP2D)10 mg/kg Q3W JS207IIADCJS207JS212II202636II420202510JS207II/III(AGA)II/IIIINDFDA EGFR/HER3(JS212) JS212EGFRHER3ADCEGFRHER3EGFRHER3HER3EGFRADCJS212EGFRHER3JS212EGFRHER3JS212 20251JS212INDNMPA20253NMPA202512JS212INDFDA JS212I/IIJS212JS212202511JS207JS212II Tifcemalimab(TAB004/JS004) Tifcemalimab(first-in-human)BT(BTLA)BTLABTLATBBTLAHVEMHerpes virus entry mediator2005HVEMTNFBTLATifcemalimabBTLAHVEM-BTLABTLA TifcemalimabIIIJUSTAR-001IIItifcemalimab(LS-SCLC)BTLA756152005602026 tifcemalimabtifcemalimab • Tifcemalimab(R/R)2025tifcemalimab(JSMO)(WCLC)2025ESMOtifcemalimab ®JT001/VV116 ®RdRpRdRp®® 2 0 2 312 8®N M P ACOVID-1920251NMPA®2023120241 ®®®® ®UBP1211 ®®20223®NMPA20225202211®NMPA ®JS002 ®PCSK9202310®® 202410®NMPA 20255®1(HeFH)2sNDAPCSK9 202512®PCSK9202611 III 20252HeFHIIIJS002-005(EAS)(Atherosclerosis ) 20256IIIJS002-007(Atherosclerosis )150mg2(Q2W)12(LDL-C)66.2%52(TRAE) IL-17AJS005 JS005IL-17AJS005IL-17JS0052023(ACR)JS005Ib/IIJS005JS005(p<0.0001) 20259JS005IIIJS005-005-III-PsO202512JS005NDANMPAJS005II 20253JS005(Acta Dermato-Venereologica )JS005PsOPsOPsO 20256JS005PsOIb/II(CSD 2025)(Late breaking research)JS005PsO (JS001sc) JS001sc®JS001sc0.3mg/kgJS001scJS001sc 20244JS001sc(FIH)2024(AACR)#CT113PD-1JS001scGP(RM-NPC)(IV)JS001sc 360mg Q3W240mg Q3WJS001sc 202511JS001sc®III20263JS001sc12NMPAPD-1JS001sc12® Claudin18.2-MMAE(JS107) JS107Claudin18.2-MMAE(Monomethyl auristatin E)Claudin18.2(ADC)JS107Claudin18.2MMAEJS107(ADCC)(CDC)MMAEJS107JS107JS107IIIJS107Claudin18.2G/GEJAIII 20254AACRJS107I# C T010Claudin18.2ADCG/GEJAClaudin18.2G/GEJAJS107XELOX+Claudin18.2ORR81.0%JS107 202512JS107G/GEJAI#LBA52025(ESMOAsia)Claudin18.2G/GEJAJS107+XELOXORR86.7%DCR100%mPFS11.14JS1072 mg/kg+100%XELOX2mg/kg+75%XELOXORR87.5%mPFS6PFS85.9%JS107XELOXClaudin18.2G/GEJAIII DKK1(JS015) JS015DKK1DKK1DKKJS015DKK1JS015II 20254AACRJS015(Late-BreakingResearchPoster)#LB212DKK1JS015JS015Ib/II(IIT)JS015JS015(CRC)ORR31.6%CRCORR80%ORR100%JS015(GC)ORR66.7% CD20CD3(JS203) JS203CD20CD3CD20BBCD3TCD3TTJS203CD20CD3CD20TCD3TJS203JS203JS203II2026 20254AACRJS203R/RBB-NHLI#CT025JS203step-up dosingSUDJS203CD20BJS20330mgBDLBCLORR80%CRR40%(DoR)JS203CD20B 20251267ASHJS203R/R B-NHLI#1957RP2DJS20330mgCD20R/RB-NHLORR72.4%DLBCLORR69.7%CRR39.4%(CRS)27.3%(ICANS) PD-1/IL-2(JS213) JS213PD-1-2(IL-2)PD-1IL-2PD-1IL-2IL-2PD-(L)1IL-2JS213PD-1IL-2JS213CD8+TT(NK)PD-1 20256JS213ASCO 2025I(FIH)#e14500IFIHJS213(MTD)RP2D(PK) 20251140(SITC)JS213I#595SITC2025619250.30.61 mg/kgJS2130.3 mg/kg •PKJS213