1、SS0880521070001 101020304 mWiXuWpZmWdU9W9UvYcV9PaO9PpNmMpNmPjMrRsQeRoOnMaQnNyQuOrMqMvPmPoR201 3Bispecific monoclonal antibody,BsAbNature Reviews Drug DiscoveryPubmed重链轻链链间二硫键铰链区可变区恒定区VLVHVHVLCLCH1CH1CLCH2CH2CH3CH30101 40101602014CrossMabPubmed 5CMCCMC/0101Pubmed 6FCFClgGlgGscFvVHHDARTTandAbMacroGeni
2、csAffimedBi-nanobodyBiTEFcADCCCDCADCPFcFcRnFcFcDuomabscFv-Fab IgGKIH-IgGCrossmabBiTE-MicrometDART-MacroGenicsTandAb-AffimedKIH-Genentech 0101Pubmed 712.e.g.TNKBlinatumomab,CD3*CD19Emicizumab,FX*FIXa0101Nature Reviews 801011+12 CMC 2014AmgenKIHscFvVHH010203 902 1020220102DLL4/VEGFATR-009 Abl BioEGFR/
3、HER3SI-B001 BCMA/CD3EElranatamab F10/F9Mim8 C5/Gefurulimab AZPD-1/VEGF AK112 HER2KN026 PDL1/CTLA-4KN046 EpCAM/CD3Catumaxomab PD1/Lag-3 MGD013 Macrogenics/VEGF/DLL4Navicixizumab BMSHER2ZW25 Zymeworks/TGF-/PD-L1Bintrafusp alfa CD20/CD3Odronextamab 9202262022+BlinatumomabAMGENCD19/CD32014/12/3ALLEmiciz
4、umabRocheFIXa/FX2017/11/16AAmivantamabJANSSENEGFR/MET2021/12/10EGFR202L NSCLCTebentafuspIMMUNOCOREgp100/CD32022/1/26FaricimabRocheAng-2/VEGF-A2022/1/28AMD/DMEMosunetuzumabBiogen/RocheCD20/CD32022/6/8CadonilimabPD-1/CTLA-42022/6/292L/3L TeclistamabJANSSENBCMA/CD32022/8/24OzoralizumabTNF-/HSA2022/9/26
5、4178169781439Talquetamab GPRC5D/CD3RRMMGlofitamab CD20/CD3Epcoritamab CD20/CD3AK104(PD1/CTLAS-4)AK112(PD1/VEGF)2L PD12022.6.29AK104ORR 33%vs KORR 15%2022.12AK112SUMMIT550 11 FaricimabAMD/DME0102FaricimabFaricimabVEGF-AAng-2FaricimabVEGFVEGF-A AAngAng-2 2 w-AMDDME Faricimab-2(Ang-2)-A(VEGF-A)AMDDME4/
6、14w-AMDDME1-22022.1.28wet-AMD42(Q8W)3(Q12W)4(Q16W)DME1414262FDA Faricimabw-AMDCRVOBRVO临床一期临床二期临床三期申请上市已上市DME计划2023年申报上市Approved in US 22Q1 and EU 22Q3BALATONCOMINO计划2023年申报上市Approved in US 22Q1 and EU 22Q3Pubmed 1280%120102AMD50AMDAMD(CNV)AMD8085%10%-15%AMDAMDAMDAMD1520%VEGFLucentisBeovuEYLEA36.41.9