Drug intelligence / Profile preview

HC034S

Development stage
Phase 1
Lead developer
Shanghai Hongcheng Pharmaceutical
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

HC034S is a cetuximab biosimilar candidate being developed by Shanghai Hongcheng Pharmaceutical and HC Biopharma. It is a chimeric human-murine monoclonal antibody that targets the epidermal growth factor receptor (EGFR). By binding to the extracellular domain of EGFR, HC034S inhibits ligand binding and receptor dimerization, thereby blocking downstream signaling pathways that promote tumor cell proliferation and survival. HC034S is being developed for the treatment of EGFR-expressing, KRAS wild-type metastatic colorectal cancer and squamous cell carcinoma of the head and neck. It is currently undergoing Phase I clinical evaluation to assess its pharmacokinetics and bioequivalence compared to the reference product, Erbitux.

02

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