Энглумафусп альфа

Rec. INN (наименование, зарегистрированное ВОЗ)

2417199-08-5

humanized immunoglobulin G1-kappa anti-(human B-lymphocyte antigen CD19) modified heterodimer where the heavy and light chain variable regions of one arm have been substituted by three subunits of human 4-1BB ligand (tumor necrosis factor ligand superfamily member 9, TNFSF9) with the following structural arrangement: human 4-1BB ligand fragment (71-248, 1-178 in the current sequence) fused via peptidyl linker ¹⁷⁹GGGGSGGGGS¹⁸⁸ to human 4-1BB ligand fragment (71-248, 189-366 in the current sequence), fused via peptidyl linker ³⁶⁷GGGGSGGGGS³⁷⁶ to immunoglobulin G1 kappa light chain constant region (377-483) variant (E³⁹²>R, Q³⁹³>K), which is linked to immunoglobulin G1 heavy chain constant region (484-710) variant (L⁴⁹⁷>A, L⁴⁹⁸>A, P⁵⁹²>G, S⁶¹⁷>C T⁶²⁹>W) and 483-291'-disulfide with human 4-1BB ligand fragment (71-248, 1'-178' in the current sequence) fused via peptidyl linker ¹⁷⁹'GGGGSGGGGS¹⁸⁸' to the immunoglobulin G1 heavy chain constant region (189'-291') variant (K²¹⁸>E K²⁸⁴>E), heterodimer with humanized immunoglobulin G1 anti- (human CD19) heavy chain (1''-452'') variant (L²³⁸>A, L²³⁹>A, P³³³>G, Y³⁵³>C, T³⁷⁰>S, L³⁷²>A, Y⁴¹¹>V), (224''-219''')-disulfide with immunoglobulin G1 anti-(human CD19) kappa light chain (1'''-219'''), produced in Chinese hamster ovary (CHO) cells, glycoform alfa; fusion protein with three copies of an extracellular domain fragment of the human 4-1BB ligand (tumor necrosis factor ligand superfamily member 9, TNFSF9), replacing the heavy chain and light chain variable regions of one arm of a modified humanized anti-[CD19 (B-lymphocyte antigen CD19, B-lymphocyte surface antigen B4, T-cell surface antigen Leu-12)] immunoglobulin G1 (IgG1) kappa: 4-1BB ligand (71-248)-peptide (1-178) / (G⁴S)² linker (179-188) / 4-1BB ligand (71-248)-peptide (189-366) / (G4S)2 linker (367-376) / IgG1 kappa light chain constant region (377-483) [Homo sapiens IGKC*01 (E³⁹²>R, Q³⁹³>K)] / IgG1 heavy chain constant region (484-710) [Homo sapiens IGHG1*01; hinge: 484-493; CH2: 494-603 (L⁴⁹⁷>A, L⁴⁹⁸>A, P⁵⁹²>G), CH3: 604-708 (S⁶¹⁷>C, T⁶²⁹>W); CHS: 709-710] fusion protein, (483-291')-disulfide with 4-1BB ligand (71-248)-peptide (1'- 178') / (G⁴S)² linker (179'-188') / IgG1 gamma-1 heavy chain constant region (189'-291') [Homo sapiens IGHG1*01; CH1: 189-286 (K218>E, K284>E)] fusion protein; heterodimer (489-230'':492-233'':617-353'')- trisdisulfide with humanized anti-CD19 IgG1 heavy chain (1''-452'') [Homo sapiens IGHV1-2*02; Homo sapiens IGHJ4*01; Homo sapiens IGHG1*01; VH: 1-121; CH1: 122-219; hinge: 220-234; CH2: 235-344 (L²³⁸>A, L²³⁹>A, P³³³>G); CH3: 345-449 (Y³⁵³>C, T³⁷⁰>S, L³⁷²>A, Y⁴¹¹>V); CHS: 450-451; CDR Kabat H1: DYIMH (31-35); CDR Kabat H2: YINPYNDGSKYTEKFQG (50-66); CDR Kabat H3: GTYYYGPQLFDY (99- 110)], (224''-219''')-disulfide with humanized anti-CD19 IgG1 kappa light chain (1'''-219''') [Homo sapiens IGKV2-29*02; Homo sapiens IGKJ2*01; Homo sapiens IGKC*01; VL: 1-112; CL: 113-219; CDR Kabat L1: KSSQSLETSTGTTYLN (24-39); CDR Kabat L2: RVSKRFS (55-61); CDR Kabat L3: LQLLEDPYT (94-102)], produced in Chinese hamster ovary (CHO) cells, glycoform alfa

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