宜明昂科-B2023年报

1541 2357101132416281122126127128129130178179 2015Drug-by-Design 202432 202432 H 183171712-1716 Kendall Arthur Smith 100015 Kendall Arthur Smith 717710 3485 8835 1541 www.immuneonco.com 20239 5 202318A 2023IMM01 20236IMM01(MDS)II2023123151(ORR)64.7%(33/51)(CRR)29.4% (15/51)≥4ORR85.3% (29/34)CRR 44.1% (15/34)≥6ORR89.3% (25/28)CRR 53.6% (15/28) 20233IMM01-(CMML)II2023123122ORR72.7%(16/22)CRR 27.3%(6/22)≥4ORR87.5%(14/16)CRR 37.5%(6/16)≥6ORR84.6%(11/13)CRR46.2%(6/13)202311FDAIMM01CMML(ODD) 202312IMM01PD-1(R/R)(cHL)II20243 1338(CR)14(PR)ORR 66.7%CRR 24.2% •20244IMM01PD-1R/R cHLIII 20236IMM0306R/RCD20B(B-NHL)Ib/IIa20241 5Ib71CR 4 PR 1 SD ORR(DCR)71.4%85.7%20233IMM2520I20239IMM47IIMM2510IMM27M IIMM2510(r/r STS)II(NSCLC)(TNBC) IMM0306(SLE)(LN)(NMOSD)INDIMM72ACTRIIA(PAH)IMM72INDIMM72IMM7211bIMM7211b 20242024IMM01IIIIMM0306B-NHLIMM2510IIIMM2902IMM2520IMM72IMM7211b 20239 5 IMM01SIRP-Fc 20231Ib/IIaINDIMM01(MM) 20236IMM01(MDS)II202312 3151(ORR)64.7% (33/51)(CRR)29.4% (15/51)≥4ORR85.3% (29/34)CRR 44.1% (15/34)≥6ORR89.3% (25/28)CRR 53.6% (15/28) 20233IMM01-(CMML)II2023123122ORR72.7% (16/22)CRR 27.3% (6/22)≥4ORR87.5% (14/16)CRR 37.5% (6/16)≥6ORR84.6% (11/13)CRR46.2% (6/13) 20231 19IMM01PD-1(R/R)(cHL)II202312II20243 1338(CR)14(PR)ORR 66.7%CRR24.2% 202311FDAIMM01CMML 20244IMM01PD-1R/R cHLIII IMM0306 (CD47CD20) 20236IMM0306R/R CD20B(B-NHL)Ib/IIaIb1.6 mg/kg2 mg/kg820241 5R/R(FL)(MZL)1.6 mg/kgIMM030620Ib71CR (FL)4 PR 2 FL 2 MZL1SD ORR(DCR)71.4%85.7% IMM2510 (VEGFPD-L1) 202311IMM2510 IIR/R(STS) 20239IMM2510 I33II(RP2D)20 mg/kg(Q2W)IMM2510 IR/R(NSCLC)202312313PR23 mg/kg10 mg/kg 120 mg/kg7SD415%13 mg/kg2NSCLC10 mg/kg20 mg/kg 120 mg/kg 202311IMM2510NSCLC(TNBC)II(IND) 202310IMM2510IMM27MIIND IMM27M (CTLA-4 ADCC+) IMM27M IIMM27M7.5 mg/kgRP2D5 mg/kg(Q3W)(BC)3 mg/kg5 mg/kgPR IMM2520 (CD47PD-L1) 20233IMM2520I202312IMM25202.0mg/kg0.1mg/kg(SCLC)2.0 mg/kgSD10%20241PD-1SCLC26.3% IMM2902 (CD47HER2) 4.0mg/kg IMM47 (CD24) 20239IMM47 I 20231012IMM47INDIMM47R/R B-NHLIND INDIND IMC-002 (IMM0306) IMC-002 (IMM0306)IND20243IND IMC-001 (IMM01) IMC-001 (IMM01)IND IMM72ACTRIIA (PAH)3L IMM7211bACTRIIA  202212 31277.35.3%202312 31291.9(i)24.9(ii)202212.2CMC13.7(i)IND(ii)9.6202312 31 202312 31379.5202212 31402.923.455.520221 31 •1202212 31225.856.0202312 31281.8 2015Drug-by-Design (1)IND11 (2)-2023118FDAIMM01CMML (3)IMM01(cHL) MDSAMLCMML-B-NHLBSTScHLFLMZLINDCMCADCCTNBCNSCLCHCCSLELNMNNMOSDMGPAH IMM01SIRP-Fc IMM01CD47SIRP-FcIgG1 FcIMM01—CD47/SIRPFcIMM01CD47(RBC)IMM01IMM01  o 202311FDAIMM01CMML 20236IMM01II57202312 3151ORR64.7% (33/51)29.4% (15/51)CR15.7%(mCR+HI)5.9%(HI)13.7%(mCR)≥4ORR85.3% (29/34)CRR 44.1% (15/34)≥6ORR89.3% (25/28)CRR53.6% (15/28)≥31.8%IMM01 20233IMM01CMMLII24202312 3122ORR72.7% (16/2227.3% (6/22)CR13.6%(mCR+HI)4.5%(HI)27.3%(mCR)≥4ORR87.5% (14/16)CRR 37.5% (6/16)≥6ORR84.6% (11/13)CRR 46.2% (6/13)IMM01CMMLIMM01CMML o 20231 19IMM01PD-1R/R cHLII202312II20243 133cHL338CR14PRORR66.7%CRR24.2%(TRAE) 2024IIPD-1cHL20244IMM01PD-1R/R cHLIII 20243 1 IMM01 o 20231Ib/IIaINDIMM01MM o IMM01CD47/SIRPIMC-001(IMM01)IND 18A.08(3)IMM01 IMM0306 (CD47CD20) MM0306CD47CD20CD47CD20-IMM0306IMM01CD47ADCCIgG1 FcADCPADCC o 202312 3148CD20RP2D2.0 mg/kg0.8 mg/kg2 mg/kg5CR5 PR 11 SDIMM0306 I2023IIII o 20236IMM0306R/R CD20B-BHLIb/IIaIb1.6 mg/kg2 mg/kg820241 5R/R(FL)(MZL)1.6 mg/kgIMM030620Ib1CR (FL)4 PR 2 FL 2MZL1SD ORR DCR71.4%85.7%IMM0306 o IMM0306BIMC-002 (IMM0306)IND20243IND IMM2510 (VEGFPD-L1) IMM2510—VEGFPD-L1VEGFPD-L1 IMM2510TIMM2510FcADCC/ADCP o 20239IMM2510I33RP2D20mg/kg20231231IMM2510 IR/R NSCLC202312 313PR13mg/kg46%20110mg/kg32%9.41(PD-L1 CPS80)20mg/kg53%8.1SD15%3mg/kg17.9%1020mg/kg24.8%18.1%20mg/kg25.3%IMM2510 202311IMM2510R/R STS II oIMM27M ◆202310IMM2510IMM27MIIND2024 o 202311IMM2510NSCLCTNBC IIIND IMM27M (CTLA-4 ADCC) IMM27MCTLA-4ADCCCTLA-4TCD80/CD86TCTLA-4CTLA-4CD80/CD86T IMM27MIIMM27M7.5mg/kgII5mg/kgI2PR13mg/kg62.5%20231231915mg/kg41.0%2023123143SD12mg/kg22.9%27.5mg/kg5mg/kg18.5%10.3%IMM27M IMM2520 (CD47PD-L1) IMM2520CD47PD-L1IMM2520ADCCIgG1FcPD-L1NIMM01CD47CD47ADCCIgG1 FcADCPADCC 20233 23IMM2520I0.1 mg/kg202312IMM25202.0 mg/kg(DLT)202312 3110SD10%0.1mg/kg21.1%PD-1SCLC2.0 mg/kg202319.0%2024126.3%2.0 mg/kg11.4%2024I IMM2902 (CD47HER2) IMM2902CD47HER2NCD47IMM2902ADCCIgG1FcADCPADCC 20222IMM2902HER2HER2Ia/Ib74.0 mg/kg2024 HER2HER22022620227 IMM47 (CD24) IMM47CD24CD24CD24IMM47CD24/Siglec-10TADCCIgG1FcIMM47ADCPADCCM1IMM47TCD24/Siglec-10T20231012IMM47INDIMM47R/R B-NHLIND 20239IMM47 I IMM72 (ACTRIIA) IMM72ACTRIIAsotaterceptPAH3L2024IND IMM7211b (ACTRIIA) IMM7211bACTRIIA IMM67 IMM67IMM67IMM672024 18A.08(3)IMM0306IMM2520 IMM2510 IMM27M IMM2902 IMM47IMM72IMM7211b IMM67 2024 18A.08(3) 2023202212 310.40.5 202212 3114.7202312 3118.22.21.3 202212 3129.4202312 311.8(i)55.520221 31(ii)26.01.8 CMC (i)CMCCROCDMOCMC(ii)(iii)(iv)(v)(vi)(vii) 202212 31277.35.3%202312 31291.9(i)24.9(ii)202212.2CMC13.7(i)IND(ii)9.6202312 31 202212 31