Drug intelligence / Profile preview

serplulimab + pimurutamab

Development stage
Phase 2
Lead developer
Henlius
Modality
Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

Serplulimab + pimurutamab is an investigational combination therapy developed by Henlius, pairing two monoclonal antibodies: serplulimab (HLX10), a recombinant humanized anti-PD-1 immune checkpoint inhibitor, and pimurutamab (HLX07), a humanized, Fc-engineered anti-EGFR monoclonal antibody. Pimurutamab is designed with an extended half-life to allow for a three-weekly dosing schedule, aligning with standard immunotherapy and chemotherapy regimens. Preclinical and clinical data suggest that the combination acts synergistically by blocking EGFR-mediated tumor cell proliferation and enhancing T-cell-mediated antitumor immunity. The combination is primarily administered intravenously in conjunction with chemotherapy and is currently being evaluated in a Phase 2/3 trial for the first-line treatment of advanced squamous non-small cell lung cancer (sqNSCLC), as well as in Phase 2 trials for esophageal squamous cell carcinoma, nasopharyngeal carcinoma, colorectal cancer, rectal cancer, small cell lung cancer, head and neck squamous cell carcinoma, and gastric cancer.

Other names
HLX07 + serplulimabpimurutamab + HLX10pimurutamab + serplulimab
02

Targets

CD28 (Cluster of Differentiation 28)EGFR (Epidermal growth factor receptor)PDCD1 (Programmed cell death protein 1 receptor)CD274 (Programmed cell death protein 1 ligand 1)PDCD1LG2 (Programmed cell death 1 ligand 2)

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