ZANIDATAMAB

UNII:	Z20OC92TDI
Type:	INGREDIENT SUBSTANCE
Formula:
Preferred Substance Name:	ZANIDATAMAB
GSRS Full Record:	Z20OC92TDI i

2169946-15-8
ANTI-HER2 BI-SPECIFIC MONOCLONAL ANTIBODY ZW25
Immunoglobulin G1, anti-(human tyrosine kinase receptor HER2) (human-Mus musculus biparatopic monoclonal ZW25 light chain variable region fragment) fusion protein with peptide (synthetic 20-amino acid linker) fusion protein with human-Mus musculus biparatopic monoclonal ZW25 heavy chain variable region fragment fusion protein with peptide (synthetic 20-amino acid linker) fusion protein with human Fc fragment, (261→229'),(264→232')-bis(disulfide) with immunoglobulin G1 anti-(human tyrosine kinase receptor HER2) (human-Mus musculus biparatopic monoclonal ZW25 γ1-chain) disulfide with human-Mus musculus biparatopic monoclonal ZW25 κ-chain
Immunoglobulin G1-kappa, anti-[Homo sapiens ERBB2 (epidermal growth factor receptor 2, receptor tyrosine protein kinase erbB-2, EGFR2, HER2, HER-2, p185c-erbB2, NEU, CD340)], humanized monoclonal antibody, biparatopic (targeting two different non-overlapping epitopes on ERBB2); gamma1 heavy chain humanized (1-449) [VH (Homo sapiens IGHV3-66*01 (78.8%) -(IGHD) - IGHJ4*01 (100%)) [8.8.12] (1-120) -Homo sapiens IGHG1*01 G1m17,1 (CH1 K120 (217) (121-218), hinge 1-15 (219-233), CH2 (234-343), CH3 T6>V (353), L7>Y (354), D12 (359), L14 (361), F85.1>A (408), Y86>V (410) (344-448), CHS K2>del (449)) (121-449)], (223-215')-disulfide with kappa light chain humanized (1'-215') [V-KAPPA (Homo sapiens IGKV1-16*01 (84.2%) -IGKJ1*01 (100%)) [6.3.9] (1'-108') -Homo sapiens IGKC*01 (100%) Km3 A45.1 (154), V101 (192) (109'-215')]; gamma1 heavy chain V-KAPPA-VH-CH2-CH3 humanized (1''-481'') [V-KAPPA (Homo sapiens IGKV1-39*01 (86.3%) -IGKJ1*01 (100%)) [6.3.9] (1''-108'') -20-mer linker (109''-128'') -VH (Homo sapiens IGHV3-66*01 (81.6%) -(IGHD) -IGHJ4*01 (100%)) [8.8.13] (129''-248'') -dialanyl (249''-250'') -Homo sapiens IGHG1*01 (hinge 1-15, C5>S (255) (251-265), CH2 (266-375), CH3 T6>V (385), D12 (391), L14 (393), T22>L (401), K79>L (427), T81>W (429) (376-480), CHS K2>del (481)) (251''-481'')]; dimer (229-261'':232-264'')-bisdisulfide, produced in Chinese Hamster Ovary (CHO), glycoform alfa
JZP598
ZANIDATAMAB [USAN]
ZIIHERA
ZW-25
ZW25
Zanidatamab
Zanidatamab [WHO-DD]
Zanidatamab hrii [WHO-DD]
Zanidatamab-HRII
zanidatamab [INN]

Note

UNIIs are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication. Please report any problems/errors associated with this data to FDA-SRS@fda.hhs.gov.

ZANIDATAMAB

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