Drug intelligence / Profile preview

pimurutamab

Development stage
Phase 3
Lead developer
Henlius
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

Pimurutamab is a glycoengineered, humanized IgG1-κ monoclonal antibody targeting the epidermal growth factor receptor (EGFR/ErbB1/HER1), developed as a cetuximab “biobetter” by Shanghai Henlius Biotech for the treatment of EGFR-expressing solid tumors.[1][5][7][11][13] By binding the extracellular domain of EGFR and antagonizing ligand-induced receptor activation, pimurutamab blocks downstream signaling pathways such as RAS–RAF–MEK–ERK and PI3K–AKT that drive tumor cell proliferation and survival, while its optimized Fc glycosylation is designed to enhance antibody-dependent cell-mediated cytotoxicity (ADCC) against EGFR-positive cancer cells.[1][5][7][11][13] It is being clinically evaluated primarily in China in phase 2–3 studies, both as monotherapy and in combination with chemotherapy and the PD-1 antibody serplulimab (HLX10), for multiple malignancies including cutaneous and other squamous cell carcinomas, non-small cell lung cancer, esophageal and nasopharyngeal carcinoma, colorectal cancer, and hepatocellular carcinoma.[1][2][4][5]

Other names
pimurutamab [INN]PimurutamabHumanized anti-EGFR monoclonal antibodyglycoengineered humanized cetuximab
02

Targets

EGFR T790M (Epidermal growth factor receptor T790M mutant)

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