维立志博-B2025 中期报告

南京維立誌博生物科技股份有限公司Nanjing Leads Biolabs Co., Ltd. （於中華人民共和國成立的股份有限公司）股份代號: 9887 24893855565758596070 24840 H 183171712-1716 199 www.leadsbiolabs.com 12205 20257 25 1838 717710 97927 9887 20257 25 •PD-L1/4-1BBLBL-024 •LBL-024LBL-024 •LBL-0244-1BB20258LBL-024 •I/IIa20256 345312833.3%51.1%2.84.12.820256 311.9677.8%85.9%70.8%20256 325.0 mg/kg12 •LBL-024Ib/II(i)20256 552336975.0%523992.3%524815 mg/kg79.2%2419II15 mg/kg83.3%15 mg/kg(ii)II2025655286.5%96.2% •LBL-02420257LBL-024II20259LBL-024Ib/II2025LBL-024II2025LBL-024II2026LBL-024 •LBL-034GPRC5D/CD3 •20255 29LBL-034I/II400-800 μg/kg82.1%LBL-034CAR-T400 μg/kgn=1877.8%≥VGPR61.1%≥CR44.4%800 μg/kgn=1090.0%≥VGPR≥CR60.0%50.0%20255 29EMD2025ASH •20258IILBL-034 II LBL-034 •LBL-007LAG3 20257 24IILBL-007PD-14283.3%397.6%15.814.7 •LBL-033MUC16/CD3 •20246 28LBL-033I/II2051910 mg/kg10 mg/kg12 •LBL-049GDF15 •20258LBL-049DRF•LBL-049 •LBL-054-ADCCDH17 ADC •20257PCC •20257TCE-ADC •LBL-061EGFR/PD-L1 ADC •LBL-047BDCA2/TACI •20259 19FDAIND LBL-047 •LBL-051CD19/BCMA/CD3 •202411 5Oblenio Bio, Inc.Aditum BioLBL-051INDCMC2026FDAIND 20246 30180.414.07.8%20256 30166.4 20246 3084.047.856.9%20256 30131.8(i) CMCLBL-024BLA(ii)LBL-024LBL-034 20246 3058.823.039.0%20256 3035.8(i)2024(ii)2025 20256 302024 T-cell engagerTCEADCPD-1/PD-L1 1.T4-1BBTTPD-1/PD-L1TCAR-T4-1BBTX-body™4-1BB4-1BBPD-L1/4-1BBLBL-024X-body™ 2.TCD3TTT90%PD-1T-cell engagerLeadsBody™CD3T-cell engagerTLeadsBody™CD3 T-cell engagerLBL-034GPRC5D/CD3LBL-033MUC16/CD3 3.TPD-1/PD-L1PD-1/PD-L1PD-1/PD-L1LAG-3TLBL-007LAG-3PD-1 6320256 30(i) 1PD-L1/4-1BBLBL-024(ii) 135LBL-034LBL-033LBL-007 LBL-019 LBL-0158LBL-043LBL-049 LBL-054-TCE LBL-054-ADCLBL-061LBL-058 LBL-051 LBL-047146LBL-024PD-L14-1BBLBL-024LBL-024202474-1BB20258LBL-024202410LBL-024NMPABTD202411FDAODD IO 2.0TCE ADCADCTT4-1BB IO 2.0X-body™LBL-024 TCETCELeadsBodyTMLBL-034LBL-033TCE4-1BBTCETCE-ADCTCE ADCDNAIDXdSN-38ADCADCTOPiKinectics™-ADCFcExatecanMDRITOPiKinectics™-ADCDXd-ADCADC LBL-054-ADCCDH17 ADC 20257PCC2026IND LBL-058DLL3/CD3 ADC 20257TCE-ADC2027IND LBL-061EGFR/PD-L1 ADC IND2026IND •PD-L1/4-1BBLBL-024 LBL-024PD-L14-1BBT4-1BBLBL-024LBL-0242:2PD-L14-1BB4-1BBPD-L11:300LBL-024PD-1/PD-L14-1BBTPD-1/L1LBL-0244-1BB4-1BB4-1BB o ◆LBL-0244-1BB20258LBL-024 ◆LBL-024PD-17.1%30% 20256 341320256 345312833.3%51.1% ◆20256 311.9677.8%85.9%70.8% o 20256 5LBL-024Ib/II52336975.0%523992.3%524815 mg/kg79.2%2419II15 mg/kg83.3%57.7%523050% Ib15 mg/kg266 mg/kg≥10%12 20256 5LBL-024II5286.5%96.2% oLBL-02420257LBL-024II20259LBL-024Ib/II2025LBL-024II2025LBL-024II2026LBL-024 18A.08(3)LBL-024 •LBL-034GPRC5D/CD3 LBL-034GPRC5DCD3T-cell engagerTLBL-034CD3 T-cell engagerLeadsBody™CD3T-cell engagerLBL-0342:1GPRC5DFabCD3scFvLBL-034GPRC5D+TGPRC5DTI/IILBL-034 o 20255 29LBL-034I/II400-800 μg/kg82.1%CAR-T400 μg/kgn=1877.8%≥VGPR61.1%≥CR44.4%800 μg/kgn=1090.0%≥VGPR≥CR60.0%50.0%EMD2025ASH 1,200μg/kg 61,200 μg/kg202541.66VGPRCR BCMA CAR-TBCMALBL-034 20255 291,200 μg/kg 12 •LBL-007LAG3 LBL-007IgG4LAG3TLBL-007LAG3LAG3LAG3MHC-IILSECtin Gal-3 FGL-1LAG3LBL-007LAG3 o 20257 24LBL-007GPII4292.9%, n=39IV22.783.3%97.6%332615.814.7LBL-00742100.0%3788.1%≥3≥31945.2%LBL-007LAG-3≥1%PD-L1≥1% LBL-007GPIIILAG-3+PD-L1+ o20255 18LBL-007LBL-007LBL-007 •LBL-033MUC16/CD3 LBL-033MUC16CD3TMUC16MUC16LBL-033LeadsBody™LBL-0342:1MUC16CD310MUC16CA125LBL-033MUC16+T o 20246 28LBL-033I/II2051910 mg/kg10 mg/kg12 •LBL-019TNFR2 LBL-019TNFR2IgG1LBL-019TNFR2TNFR2CD8+ T200%CD4+ T30%FcCD25PD-1 4-1BBLBL-019TCD4+CD8+ TT •LBL-015PD-1/TGF-R2 LBL-015PD-1/PD-L1-βTGF-βLBL-015PD-1PD-1IgGFcTGF-βR2LBL-015PD-1TGF-β1PD-1/PD-L1PD-1/PD-L2TGF-βPD-1/PD-L1TGF-β •LBL-061EGFR/PD-L1 ADC LBL-061ADCEGFRPD-L1EGFR o20257LBL-061IND •LBL-054-ADCCDH17 ADC LBL-054-ADCCDH17ADC CDH1750%90%CDH17ADCLBL-054-ADCCDH17IgG1FcDAR6ITOP1i o20257PCC •LBL-054-TCECDH17/CD3 LBL-054-TCECDH17T-cell engagerCDH17LBL-054-TCECDH17LeadsBody™T-cell engagerLBL-054-TCECDH17CD3TCDH17 o20257PCC •LBL-058DLL3/CD3 ADC LBL-058Delta3DLL3T cell engagerTECDLL3DLL3LBL-058DLL357%LBL-058TCEADCTECDLL3TCEITOP1iDLL3CD3DLL3TCD3LBL-058DLL3TITOP1iDLL3 20257TCE-ADC •LBL-043LILRB4/CD3 LBL-043B4LILRB4CD3AMLLBL-043LeadsBody™ T-cell Engager2:1 •LBL-049GDF15 LBL-049GDF15GDF15-GFRAL o20258LBL-049DRF •LBL-051CD19/BCMA/CD3 LBL-051CD19/BCMA/CD3B202411 5LBL-051Oblenio Bio, Inc.Aditum Bio INDCMC2026FDAIND •LBL-047BDCA2/TACI LBL-047BDCA2TACIBBDCA2pDCBIgALBL-047Fc o20259 19FDAIND 18A.08(3)LBL-034LBL-033LBL-007LBL-019LBL-015LBL-061LBL-054-ADCLBL-054-TCE LBL-058 LBL-043 LBL-049 LBL-051 LBL-047 T-cell engagerLeadsBodyTMCD3 T-cell engagerX-bodyTM4-1BB engagerTOPiKinectics™ADC •LeadsBody™CD3 T-cell engager LeadsBodyTMCD3(i)(ii)CD3(iii)T(iv) LeadsBodyTM(i)CD3T-cell engager(ii)T(iii)T-cell engagerT LeadsBodyTMCD3 T-cell engagerLBL-034GPRC5D/CD3LBL-033MUC16/CD3 •X-body™4-1BB engager X-bodyTM2:2(i)4-1BB(ii)4-1BB4-1BB(iii) X-bodyTM4-1BB/PD-L1LBL-024LBL-0244-1BB •TOPiKinectics™ADC DNAIDXdSN-38ADCADCTOPiKinectics™-ADCFcExate