博安生物2023年度报告

股份代號: 6955（於中華人民共和國註冊成立的股份有限公司） 2023年報 2357928375053707576788082 2013T-cellEngagerADC T 20232 12202312 12 39 39 FCGHKFCG 3485 H 183171712–1716 9 100020118 97927 6955 www.boan-bio.com Bank of AmericaCitibank N.A., Singapore Branch 1. 202312 31 202312 31618.1202212 31516.0102.119.8%®(BA1101)®(BA6101) 2. 202212 31161.7202312 31209.233.9%202231.3% 3. 202312 31408.9202212 3154.715.4% 4. 202312 31256.5202212 31214.142.419.8% 5. 202312 31230.7202212 31169.62023III 6. 202312 31 202319.8%6.18122.7%47.91.19464.0%2023 20232®®BA61016BA1102(BLA)BA5101BA9101BLABA1104BA1102BA6101 T-cell Engager(ADC)BA2101IL-4RBA1202CEA/CD3BA1106IL-2CD25BA1301Claudin 18.2 ADCBA1105Claudin 18.2 T ®2.0 ISO9001ISO14001 ISO45001GMP 20243 25 T-cell EngagerADC T 20232023 2023 ®(BA1101)®(BA6101)202219.8%618.1202312®5®1,68832220231®®642820® 2023BLA20233BA110220234Boyuno®®(Agência Nacional de VigilânciaSanitária)ANVISAIIIBA1104III202310BA6101BA1102III20241BA51012024 3IIIBA910120244III(BA2101)IIBA1105BA1301BA1202 BA1106IBA1105BA1301FDAODD 202312 313032023104354515 9,000L700L4*500L1*2,000L3*2,000L20241Boyuno®ANVISAGMPPIC/SANVISAGMPQCANVISA GMPBoyuno2023(PHDI) 20241BA2101COPDBA-HIEXcell® 20233 1320234 12B 2023 •20234ANVISABoyuno®20241Boyuno®ANVISAGMPBoyuno® •202312®5 ®BA6101RANKG2® 202211 •20231®®® •202312® •20235BA6101BA1102IIIFPI •20241FDAEMAPMDAFDAEMA PMDAIIIBA6101BA1102®® BA1102RANKG2® BA1102®RANKG2RANKLOPG/RANKL/RANK BA1102GCTB1≥45kg •20233BA1102 •20235BA6101BA1102IIIFPI •20241FDAEMA PMDAFDAEMA PMDAIIIBA6101BA1102®® BA51011 (GLP-1)® 1 (GLP-1)11HbA1c11BA5101 •20235BA5101III20243IIIBA5101III BA9101® VEGFRVEGFR1 Ig2VEGFR2 Ig3IgG1FcVEGF-AVEGF-B PlGFVEGFVEGF-APlGF®EYLEA®2011FDAwAMDRVODME(DR)(ROP)2018wAMDDME •20233BA9101III20244III202010BA9101 III1477BA9101BA9101BA9101 BA11041(PD-1)PD-1PD-L1PD-L2T® •202310BA1104III BA21014IL-4RIgG4 IL-4IL-13Th2IgETh2BA2101COPD(CSU)2BA2101BA210141IBA2101II •2023BA2101I20241BA2101II •20241BA2101BA2101COPDBA2101COPD BA1202CEA/CD3 BA1202TCD3CEACEA/CD3TCD3CD3CD3CD3+TT(Bispecific T-cell Engager, BiTE)CD3TCD3TTCD3PD-L1CEACAM5CEA BA1202CEATCD3FcTCEACRS •20235BA1202IND20238BA1202I BA1106IL-2CD25 BA1106CD25CD25CD25BA1106CD25FcIL-2BA1106 BA1106ADCCTregTBA1106PD-1BA1106IL-2TregBA1106NatureScientific Reports •20232BA1106I BA1301Claudin 18.2ADC BA1301Claudin 18.2Claudin 18.2 •20231BA1301IND6I •202312BA1301FDAODD2024 1BA1301FDAODD BA1105Claudin 18.2IgG1 Claudin 18.2BA1105Claudin 18.2IgG1ADCCBA1105FcADCC •202312BA1105FDAODD2024 1BA1105FDAODD BA1302CD228ADC CD228GPICD228CD228sMFI2BA1302(BNLD11) BA1302(MTD)10 mg/kgBA1302First-in-classADC •202351919th Essential Protein Engineering & Cell TherapySummit2023 PEGS BostonBA1302 T-cell EngagerADC CMCCMC CMC 202312 31303 3545 (Nature)(Cell Discovery)Antibody Therapeutics(Cancer Communications)15 QPQP84,474700L9,000L202312 31432 202392023(PHDI) 202342023 ®® 19.8%618.1516.0®® 202312 3170 202312 312002,700 20231®®® ® BA9101BA910120244BA9101III BA2101BA2101COPDBA2101 GenCircle™ dsDNAGenCircle™ dsDNADNAGMPGenCircle™ dsDNASTEALTH CAR-T™ReceptorTAC™ BA-HIEXcell®BA-HIEXcell® 2024 202212 3020232024BA1102(BA5101)(BA9101)BA6101BA1102(BA5101)III2024 ®® ® 4BA1102BA5101 BA9101 BA11043®BA6101BA1102 ®®2,000L BA1102BA6101BA5101 20231231618.120221231516.0102.119.8%®(BA1101) 202212 31161.7202312 31209.233.9%202231.3% 202312 31408.9202212 3154.715.4% 27.7202224.3 202212 3182.3202312 3151.7202212 3143.1 202312 31256.5202212 31214.142.419.8%202312 31 202312 31230.7202212 31169.62023III 202312 3114.1202212 3113.40.75.2%202312 31 2022202312 31 202312 31119.4202212 31331.7 2023 202312 31201.9202212 31233.513.5%202312 3159.7202212 31375.0202212 311.80202312 311.09 202312 31396.2202212 31293.3102.92023202312 222022202312 312021250.020265202312 3123.81.14%2.20% 167.8228.420231231 202312 31202212 3120.7%30.0% 202312 31225.02022236.4 20231231104.32022121.8 202312 31 202312 31270.3 202312 31 202012 20.6202218.5 202312 31813202212 3174520231231127.520221231121.4 202312 315% 202312 31 20244 12300,000,00074,142,360H20244 12 202312 31 202312 312022 202312 31 4620206 2220223 252519989202091998720075KEDGE20126200311 61201911 1620223 25201312Boan Boston LLCBoan Boston2519959199911Memorial Sloan Kettering Cancer Center199911200512RegeneronPharmaceuticals, Inc.®2006220071120071220093Invitrogen CorporationCellular Dynamics International2011720126A-Bio Pharma Pte. Ltd201272013121984719883199512 29CAR-T17202120244 1.Wang Y, Yan A, Song D, et al. Identification of a highly conserved neutralizing epitope within the RBD region of diverse SARS-CoV-2variants. Nat Commun. 15(1):842 (2024) 2.Wang Y, Yan A, Song D, et al. Biparatopic antibody BA7208/7125 effectively neutralizes SARS-CoV-2 variants including Omicron BA.1-BA.5. Cell Discov. 9(1):3 (2023)3.Song, D., Liu, X., ong, C. et al. Two novel human anti-CD25 antibodies with antitumor activity inversely related to their affinity and invitro