映恩生物-B2025中期报告

中 期 報 告 2 AACRADAM99ADCAdcendoAdcendo ApSECIIIIVECASCOAvenzoAvenzo Therapeutics, Inc.BCBDCA22IICBeiGene, Ltd.ADCBsADCADCBsAb DOR EGFRmEGFREGFR FDA HNSCC ICS IND OCORROSEGFRPD-L11T1TPFS20212282023625PROC20254 720256 30rPFSSCLC0.0001 SGO 62215 TNBC(ER)(PR)HER2/neu TRAE TROP2 % 2019ADCDB-1303/BNT323HER2 ADCECBCDB-1311/BNT324B7-H3 ADCSCLCCRPCESCCHNSCC(i)ADCDB-1310DB-1305/BNT325 DB-1312/BG-C9074 DB-1419 DB-2304(ii)ADCBsADCDB-1418/AVZO-1418DB-142120252026(iii)ADC Harneys Fiduciary (Cayman) Limited 4th Floor, Harbour Place103 South Church StreetGeorge TownP.O. Box 10240Grand Cayman KY1-1002Cayman Islands 99B3301 868A11 24840 1526 22 4th Floor, Harbour Place103 South Church StreetP.O. Box 10240Grand Cayman KY1-1002Cayman Islands 183171712-1716 www.dualitybiologics.com 2025415ADC 2600600IO 2.0+ADCBioNTech HER2 ADC DB-1303/BNT323her2DB-1303/BNT323HER2IIIHER2BLAHER2 HER3 ADC DB-1310FDA7EGFR/HER3ADC DB-1418AvenzoADC, DB-2304BDCA2ADCADAM9 ADC DB-13179 20252025ASCO AACR SGODB-1418AvenzoDB-1303 HSCIHSHKBIOMSCI Connect, ExcellenceOwnershipWe are C.E.OCP²(Clinical development)(Platforms)(Pipeline)ADC 1.202541520256 3020246302,219.8421.3 2. 20252,600202560050% •20257HER3ADC DB-1310FDA(nsqNSCLC)EGFR19L858REGFR(TKI) •20257Avenzo Therapeutics, Inc.AvenzoEGFR/HER3BsADCDB-1418/AVZO-1418 1/21DB-141820256FDAIND •2025ASCO202553063DB-1310(HER3 ADC)DB-1311/BNT324 (B7-H3 ADC)46EGFRmNSCLCDB-1310ORR43.5%DCR91.3%mPFS7.034.148.4152CRPCDB-1311ORR30.8%DCR90.4%6rPFS67.7% (n=68) •2025AACR20254BNT327 (PD-L1xVEGFbsAb)DB-1305PROCNSCLC TNBCDB-1419 (B7-H3xPD-L1 BsADC)(NCT06554795) •2025AACRDUPACDUPACADCDUPACDxd •20253SGODB-1305/BNT3251/2 •ADAM9ADCDB-13171 BioNTechADC BioNTech SE (BioNTech)DB-1303/BNT323DB-1311/BNT324 DB-1305/BNT325BNT327(PD-L1xVEGF bsAb) •DB-1303/BNT323BNT327(PD-L1xVEGF bsAb)20255DB-1303/BNT323BNT327(PD-L1xVEGF bsAb)1/2(NCT06827236)(HR+)(HR-)2(HER2)TNBC •DB-1311/BNT324BNT327(PD-L1xVEGF bsAb)20255DB-1311/BNT324BNT327(PD-L1xVEGF bsAb)1/2(NCT06892548) •DB-1311/BNT324BNT327 (PD-L1xVEGF bsAb)DB-1305/BNT32520257DB-1311/BNT324BNT327PD-L1xVEGF bsAbDB-1305/BNT3252(NCT06953089) •DB-1305/BNT325BNT327 (PD-L1xVEGF bsAb)DB-1305/BNT3251/2(NCT05438329)DB-1305/BNT325BNT327(PD-L1xVEGF bsAb) 2019ADC ADCADCADCADCADC13ADC DB-1303/BNT323ECBCHER2 ADCDB-1311/BNT324SCLCCRPC ESCCHNSCCB7-H3 ADC(i)ADCDB-1310DB-1305/BNT325DB-1312/BG-C9074DB-1419 DB-2304DB-1418/AVZO-1418(ii)ADCBsADCDB-14212026 DB-1303/BNT323 DB-1303/BNT323HER2 ADCBioNTechDB-1303/BNT323BLA2025HER2ECDB-1303/BNT323DB-1303/BNT323HER2HER2 DB-1303/BNT323FDAECDB-1303/BNT323ECBCEC OC CRCDB-1303/BNT323 DB-1303/BNT323BioNTech •3D Y N A S T Y - B r e a s t 0 2NCT06018337DB-1303/BNT323HR+HER24/6(CDK4/6)6532PFSOSORR DCR DOR •DB-1303/BNT3233(NCT06340568)2025 •DB-1303/BNT323T-DM13HER2+BC2025BLA •1/2(NCT05150691)DB-1303/BNT323HER2HER2IHC3+2+1+ISH •20255DB-1303/BNT323BNT327PD-L1xVEGF bsAb1/2(NCT06827236)(HR+)(HR-)2(HER2)TNBC DB-1303/BNT323 DB-1311/BNT324 DB-1311/BNT324B7-H3 ADCB7-H3B7B7-H3CRPCSCLCNSCLCESCCHNSCCDB-1311/BNT324B7-H3DB-1311/BNT324B7-H3Fc2024FDADB-1311/BNT324CRPCESCCSCLCBioNTechDB-1311/BNT324 •1/2(NCT05914116)DB-1311/BNT324202562025ASCOCRPCDB-1311/BNT32420253473CRPC43.8%28.8%27.4%41-1495.9%(NHT)93.2%39.7%21.9%-17752CRPCDB-1311/BNT324ORR30.8%DCR90.4%6rPFS67.7%(n=68)6 mg/kg9 mg/kgCRPCn=73DB-1311/BNT324TRAE≥3 TRAE90.4%42.5%n=465TRAE≥3TRAE92.3%47.3%202513DB-1311CRPCPFS8.3 CRPCDB-1311/BNT324SCLCHNSCCHCCCC 2024ESMO Asia •DB-1311/BNT32420255DB-1311/BNT324BNT116mRNANSCLC1(NCT05142189)DB-1311/BNT324BNT327(PD-L1xVEGF bsAb)1/2(NCT06892548)20257DB-1311/BNT324BNT327(PD-L1xVEGF bsAb)DB-1305/BNT3252(NCT06953089) DB-1311/BNT324 DB-1310 DB-1310HER3 ADCHER3EGFRHER2HERHER3HER3HER3HER3EGFRHER2DB-1310DB-1310HER3 HER3 ADC •20256DB-13101/2(NCT05785741)2025ASCODB-1310 20254 111721.5mg/kg6.5mg/kgDB-131046DB-1310(3mg/kg-6mg/kg)EGFRm NSCLC86%EGFR TKI92%31-11ORR43.5%DCR 91.3%PFS7.034.148.41OS18.9011.6NE5mg/kgn=16ORR37.5%DCR 87.5%PFS8.282.96NEOS5.5mg/kgn=12ORR66.7%DCR91.7%PFS4.112.73NEOS •DB-1310EGFREGFRmNSCLCEGFRm NSCLC •DB-1310BCCRPC HNSCC ESCCBTCDB-1310HR+ HER2-DB-13101(Topo1i)ADCHER2+ D B - 1 3 1 0F D A(nsqNSCLC)(EGFR)19L858REGFR(TKI) DB-1310 DB-1305/BNT325 DB-1305/BNT325TROP2 ADCTROP2ADC20241FDADB-1305/BNT325DB-1305/BNT325NSCLCOCCCTNBC BioNTechDB-1305/BNT325 •1/2(NCT05438329)DB-1305/BNT325 202532025SGO1/220241215DB-1305/BNT325PROCORR41.4%DCR82.8%DOR7.3PFS7.4n=58 •1/2DB-1305/BNT325BNT327(PD-L1xVEGF bsAb)NSCLCOC CC TNBC 20254BNT327(PD-L1xVEGFbsAb)DB-1305/BNT3252025AACRn=67(i)TRAE4.5%(ii)PROCn=1373NSCLCTNBC DB-1305/BNT325 DB-1419 DB-1419B7-H3xPD-L1 BsADCDNAIB7-H3xPD-L1 BsADCTDB-1419 FDADB-1419IND20249DB-14191/2a202542025AACRDB-1419(NCT06554795) DB-1418//AVZO-1418 DB-1418EGFRxHER3 BsADCDB-141820254AACREGFRHER3AVZO-1418/DB-1418EGFR TKINSCLC 202412AvenzoAvenzoDB-141820257AvenzoDB-14181/21 DB-2304 DB-2304SLECLEBDCA2 ADCBDCA2 ADCDB-2304SLE/CLEDB-2304SLECLEADCDB-230412025 DB-1419DB-1418/AVZO-1418DB-2304 ADC ADCADCDITACDIBAC DIMAC DUPACADC