宜明昂科-B2025中期报告

1541 24782538394041424356 2025528 H 183171712–1716 2025528 Kendall Arthur Smith Kendall Arthur Smith 100015 2025630Kendall Arthur Smith2025630 33191918 8835 1541 www.immuneonco.com 20239 5 20239 5 •IMM01SIRP-Fc 20236IMM01(MDS)II202412 31202412 3126.0(95%CI23.5–28.3)51(ORR)64.7%33.3%(CR)15.7%(mCR+HI)3.9%HI 11.8%mCR(IMM01)(AZA)MDS 20235IMM01-(CMML)II202412 31202412 3121.0(95%CI19.3–23.3)22ORR72.7%27.3% CR13.6%(mCR+HI)4.5% HI27.3% mCR(PFS)17.8(95% CI5.3–NR)12PFS59.0% (95% CI33.4–77.6)(IMM01)AZACMMLAZACMML-1-2 202312IMM01PD-1(R/R)(cHL)II20253 31202533116.8(95%CI15.4–21.8)338CR15PR(ORR)69.7%(CR)24.2%(mTTR)1.6(mDoR)21.2(95% CI7.5–NA)(mPFS)14.7(95% CI7.0–NA)(OS)18OS91.6% 20244IMM01PD-(L)1cHLIII2024720256 30 20246IMM01CMMLIIIIND20241120256 30 20253IMM01IMM2510IND •IMM2510(VEGFPD-L1) 202311IMM2510Ib/II20256 3015034(NSCLC)(NSCLC)2025(WCLC)ORR35.3%(6/17)DCR 76.5%(13/17)PFS9.4(95%CI1.87–NA)IMM2510 202412IMM2510NSCLCII20257133NSCLC (10mg/kg)21ORR61.9% (13/21)NSCLCORR80.0% (8/10)IMM2510-003(TNBC)20256 1020258 154TNBC32PR 1 SDPD-L1 CPS1 202310IMM2510IMM27MINDIMM2510–002IMM2510IMM27MR/RIb/II202472024720256 30 •IMM0306(CD47CD20) IMM0306R/R(FL)(MZL)Ib1.6mg/kgIIRP2DIMM030620R/RFL MZL 20243IIaCD202025ASCO20253 143418CR12PRORR CRR88.2%52.9%2025 •IMM2520 (CD47PD-L1) IMM2520I20257 226 •IMM0306(CD47CD20) 202410(SLE) Ib192025820257 11570.8 mg/kg81.2mg/kg20257 1SLEDAI-2000≥40.8 mg/kg85.7% (6/7)1.2 mg/kg87.5% (7/8)(PGA)100% (15/15)(CRS)2025(ACR) 202412(NMOSD)Ib2025813 202412(LN) IIIND 2025IND •IMM01SIRP-Fc IMM01IND •IMM72/IMC-003 (ActRIIA 20256IND8 •IMM7220/IMC-010 (GLP-1 x ActRIIA  •IMM91/IMC-0118 (GDF8) IND 20255 720257 30InstilBio,Inc.Instil(NasdaqTIL)AxionBio,Inc.Axion BioSynBioTx Inc.510Axion Bio30Instil20248 12024822202491120255720257220257 30 •20256 3038.020246 300.137.9Axion Bio, Inc. •20246 30119.141.0%20256 30168.0(i)CMC43.4IMM01IMM2510IMM0306CDMO(ii)8.3IMM01IMM2510(iii)4.96.720256 30 2015Drug-by-Design12 (1)IND11 (3)IMM01PD-(L)1(cHL) •IMM01SIRP-Fc IMM01CD47SIRP-FcIMM01IgG1 Fc—CD47/SIRPFcIMM01CD47(RBC)IMM01IMM01 o 20236IMM01MDSII57202412 3126.0(95% CI23.5-28.3)51ORR64.7%33.3% CR15.7% mCR(HI)3.9% HI 11.8% mCR≥6ORR89.7% (26/29)CR58.6% (17/29)≥3(TRAE)≥10%)(78.9%)(66.7%)(66.7%)(57.9%)(45.6%)(17.5%)(12.3%)1(1.8%)3(IMM01) ◆20245IMM01MDSIII(IMM01-009) ◆20235IMM01CMMLII24202412 3121.0(95% CI19.3–23.3)22ORR72.7%27.3%CR13.6%mCRHI4.5%HI27.3%mCR≥6ORR84.6%(11/13)CR46.2%(6/13)PFS17.8(95% CI5.3–NR)12PFS59.0% (95% CI33.4–77.6)≥3TRAE≥10%)(66.7%)(62.5%)(58.3%)(50.0%)(29.2%)(16.7%)IMM01CMMLIMM01CMML ◆202311IMM01CMML ◆20246IMM01CMMLIII(IMM01-010)2024112025630 o 20231 19IMM01PD-1(R/RcHL)IIII20231220253 3120253 3116.8(95% CI15.4–21.8)338CR15PRORR69.7%CRR 24.2%(mTTR)1.6(mDoR)21.2(95% CI7.5–NA)mPFS 14.7(95% CI7.0–NA)OS18OS91.6%TRAE(3.0%)IMM01TRAE 20253 31 IMM01 ◆ ◆20244IMM01PD-(L)1cHLIII20247(TRAE) oIMM2510 ◆20253IMM01IMM2510IND o ◆IMM01CD47/SIRPIMM01IND 18A.08(3)IMM01 •IMM2510(VEGFPD-L1) IMM2510—VEGFPD-L1VEGFPD-L1IMM2510TIMM2510FcADCC/ADCP o ◆20256 3015034NSCLCNSCLC2025(WCLC)ORR35.3%(6/17)DCR 76.5%(13/17)PFS9.4(95%CI1.87–NA)IMM2510 o ◆202311IMM2510NSCLCTNBC IIIND202412NSCLC20257 133NSCLC (10mg/kg)21ORR61.9% (13/21)NSCLCORR80% (8/10) ◆IMM2510-003TNBC20256 1020258154TNBC32PR 1 SDPD-L1 CPS1 oIMM27M ◆202310IMM2510IMM27MINDIMM2510–002R/RIMM2510+IMM27MIb/II2024720247 2320256 30 •IMM27M(CTLA-4 ADCC IMM27MCTLA-4ADCCCTLA-4TCD80/CD86TCTLA-4CTLA-4CD80/CD86T IMM27MIIMM27MRP2D20241231I2PR 20249(HR+)HER220256 30 •IMM0306(CD47CD20) IMM0306CD47CD20CD47CD20-IMM0306CD47ADCCIgG1 Fc(ADCP)(ADCC) o ◆20236IMM0306R/R CD20B-NHLIb/IIa ◆IMM0306R/R(FL)(MZL)Ib1.6mg/kg(RP2D)IMM030620R/RFLMZL ◆20243IIaR/R CD202025ASCO20253 143418CR12PRORR 88.2%CRR 52.9%TRAE(TRAE)2025 ◆IMM0306IIa •IMM2520 (CD47PD-L1) IMM2520CD47PD-L1IMM2520ADCCIgG1FcPD-L1NIMM01CD47CD47ADCCIgG1 FcADCPADCC 20233 23IMM2520I0.1mg/kg20257226 •IMM0306(CD47CD20) IMM0306B 202410SLE Ib1920258SLE2025711570.8 mg/kg81.2mg/kg20257 1SLEDAI-2000≥40.8mg/kg85.7%(6/7)1.2 mg/kg87.5%(7/8)PGA100%(15/15)CRS2025(ACR) 202412(NMOSD)Ib2025813 202412(LN) IIIND 2025IND •IMM72/IMC-003 (ActRIIA IMM72/IMC-003ActRIIAsotatercept20256IND8 •IMM7220/IMC-010 (GLP-1ActRIIA IMM7220/IMC-010ActRIIAGLP-1RFc •IMM91/IMC-0118 (GDF8) IMM91IND •IMM67 IMM67IMM67IMM67 18A.08(3)IMM2510IMM27M IMM0306 IMM2520 IMM72/IMC-003IMM7220/IMC-010IMM91/IMC-011 IMM67 20255 720257 30InstilAxion Bio510Axion Bio30Instil20248 12024822202491120255720257220257 30 2025 18A.08(3) 202520246 3038.077,000Axion Bio 20246 304.320256 309.75.3 20246 3019.520256 302.73627.46.9 CMC (i)CMCCROCDMOCMC(ii)(iii)(iv)(v)(vi)(vii) 20246 30119.141.0%20256 30168.0(i)CMC43.4IMM01IMM2510 IMM0306CDMO(ii)8.3IMM01IMM2510(iii)4.96.720256 30 20246 3030.19.3%20256 3027.320256 30 20246 301.420256 302.4 202420256 30 20246 30165.820256 30152.7 202412 30100%98,188,983.5520252 2166,178,983.55202412 3020252 21 20256 30703.7202412 31752.1 20256 30725.7298.3405.422.020256 30218.052.