宜明昂科-B2025年报

(於中華人民共和國註冊成立的股份有限公司)股份代號：1541 年 報2025 2358121333416383132136137138139140185186 ()2015Drug-by-Design12 2025528 H 183171712–1716 2025528 Kendall Arthur Smith 2 315 Kendall Arthur Smith 883 Kendall Arthur Smith20256302025630 271 100015 33191918 8835 1541 www.immuneonco.com 20239 5 2025III 2025IMM01 202512 31-(CMML)III10420263 23132FDA(MDS)III 202512 31PD-(L)1(cHL)III2024720253 3116.8(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%CI 7.0–NA)(OS)18OS91.6% 20253IMM2510IND202510 CD47/SIRP202511IND20261IIIND 202512 31IMM2510Ib/II18332(IO)(SQ-NSCLC)2025(WCLC)SQ-NSCLC17SQ-NSCLCORR35.3%(6/17)DCR 76.5%(13/17)DoR7.59(95%CI 4.07–NA)PFS9.4(95% CI1.87–NA)2026ASCO IMM2510(NSCLC)II202412202512 3169NSCLCORR61.9%ORR80.0% IMM2510IMM27MIb/II2024733241(ESCC)4 20257IMM2510INDIb/II 202512 31IMM0306(R/R FL)IIa2025ASCO ASH34ORR91.2%(CRR)67.6%PFS9.02(95% CI75.1–97.1)2025 11R/R FLIIIIND2026EHA 2025(SLE)Ib2025820259 101870.8 mg/kg111.2mg/kg0.8mg/kg1.2 mg/kg24SRI-471.4% (5/7)80% (4/5)24DNAC3/C4(CRS)2026(EULAR) (NMOSD)Ib2025820261(LN)IIIgG4(IgG4-RD)II/III(PMN)IIIND IMM72/IMC-003ActRIIA-Fc(PAH)20256IND8202512(SAD)520263(MAD)2IMM72IMM7220/IMC-010GLP-1 x ActRIIAIMM91/IMC-011GDF8IMM9101/IMC-015GDF8 ActRIIIND 20262026-(CMML)III(R/RFL)IIIIb/IINSCLCIb/II2026Ib/IIIMM72/IMC-003ActRIIA-FcIMM91/IMC-011GDF8IMM9101/IMC-015GDF8 ActRII •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 •20246IMM01CMMLIIIIND202411202512 311042026323132 •202312IMM01PD-1(R/R)(cHL)II20253 3120253 3116.8(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)1cHLIII20247202512 31 •20253IMM01IMM2510IND202510 •IMM2510(VEGFPD-L1) •202311IMM2510Ib/II202512 3118332IO(SQ-NSCLC)2025(WCLC)SQ-NSCLC17SQ-NSCLCORR35.3% (6/17)DCR 76.5% (13/17)DoR7.59(95% CI4.07–NA)PFS9.4(95% CI1.87–NA)2026ASCO •202412IMM2510NSCLCII2025123169NSCLC •202310IMM2510IMM27MIb/IIIMM2510-002IND33241(ESCC)4 20257IMM2510INDIb/II IND oSQ-NSCLCII202512 •IMM0306(CD47CD20) •IMM0306R/R(FL)(MZL)Ib1.6mg/kgIIRP2DIMM030620R/RFL MZL•20243IIaCD202025ASCO 2025 ASHORR91.2% (31/34)CR 67.6% (23/34)PFS9.02(95% CI75.1–97.1)202512312026EHA•202511IMM0306R/RIIIIND202512 31 •IMM2520 (CD47PD-L1) •IMM2520I 202512 3126 •IMM0306(CD47CD20) •202410(SLE) Ib192025820259 101870.8 mg/kg111.2mg/kg0.8 mg/kg1.2 mg/kg24SRI-471.4%(5/7)80%(4/5)24DNAC3/C4(CRS)2026EULAR •202412(NMOSD)Ib20261 •IND (LN) II202412IgG4(IgG4-RD) II/III20262(SLE)II20263(PMN) II20263 •IMM01SIRP-Fc o20261IIIND •IMM72/IMC-003 (ActRIIA •20256IND8o202512(SAD)5o20263(MAD)23 •IMM7220/IMC-010 (GLP-1 x ActRIIAoo •IMM91/IMC-0118 (GDF8) ••IND •IMM9101/IMC-015GDF8 x ActRII ooIND •202512 31154.3202412 3174.180.22024Axion Bio, Inc. •202412 31202512 31322.8322.3 2015Drug-by-Design12 (1)IND11 (3)IMM01PD-(L)1(cHL) •IMM01SIRP-Fc IMM01CD47SIRP-FcIMM01IgG1 Fc—CD47/SIRPFcIMM01CD47(RBC)IMM01IMM01 o 20236IMM01MDSII57202412 3126.0(95%CI 23.5-28.3)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) ◆20235IMM01CMMLII242024123121.0(95% CI19.3–23.3)22ORR72.7%27.3% CR13.6%mCRHI 4.5% 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)202411202512 31 ◆202512 31IMM01-(CMML)III10420263 23132 o ◆20231 19IMM01PD-1(R/R cHL)IIII20231220253 3120253 3116.8(95%CI15.4–21.8)338CR15PRORR69.7%CRR24.2%(mTTR)1.6(mDoR)21.2(95% CI7.5–NA)mPFS14.7(95% CI7.0–NA)OS18OS91.6%TRAE(3.0%)IMM01TRAE ◆20253 31 IMM01 ◆20244IMM01PD-(L) 1cHLIII20247(TRAE) oIMM2510 20253IMM01IMM2510IND202510 o ◆IMM01CD47/SIRP202511IND20261IND 18A.08(3)IMM01 •IMM2510(VEGFPD-L1) IMM2510—VEGFPD-L1VEGFPD-L1,IMM2510TIMM2510FcADCC/ADCP o ◆202311IMM2510Ib/II2025123118332(IO)(SQ-NSCLC)2025(WCLC)SQ-NSCLC17SQ-NSCLCORR35.3% (6/17)DCR 76.5% (13/17)DoR7.59(95% CI4.07–NA)PFS9.4(95% CI1.87–NA)2026ASCO o ◆202311IMM2510NSCLCIIIND202412NSCLC202512 3169NSCLC oIMM27M ◆202310IMM2510IMM27MIND33241ESCC4 20257IMM2510INDIb/II IND oESCCII202512oSQ-NSCLCII202512oII/III20261 20261Instil Bio, Inc.Axion Bio, Inc.AxionIMM2510IMM27MAxionAxionIMM2510IMM27MAxion35 •IMM27M(CTLA-4 ADCC IMM27MCTLA-4ADCCCTLA-4TCD80/CD86TCTLA-4CTLA-4CD80/CD86T IMM27MIMM2510R/RIb/II2024733241ESCC4 •IND oESCCII202512oSQ-NSCLCII202512oII/III20261 •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 CD2020