On April 14, 2026, Henlius Biotech (2696.HK) announced that its Investigational New Drug (IND) application for HLX05-N (recombinant anti-EGFR human-mouse chimeric monoclonal antibody injection), a cetuximab biosimilar developed by the company, was approved by the National Medical Products Administration (NMPA) of China for the treatment of metastatic colorectal cancer.

Epidermal growth factor receptor (EGFR) belongs to the ErbB family of cell surface erythroleukemia virus oncogene homologs with tyrosine kinase activity. It is a transmembrane glycoprotein widely expressed in normal epithelial cells and tumor tissues such as colorectal cancer and head and neck cancer. EGFR-mediated signaling pathways regulate tumor growth through multiple pathways and play a key regulatory role in the proliferation, differentiation, survival, and metastasis of tumor cells. Therefore, it is considered an important therapeutic target for related tumors.

Cetuximab specifically binds to EGFR on the cell surface. On one hand, it competitively inhibits the binding of ligands such as EGF to EGFR, inducing EGFR internalization and downregulating its expression on the cell surface. This blocks tyrosine kinase-dependent phosphorylation and multiple intracellular signal transduction pathways, thereby inhibiting cell proliferation, inducing apoptosis, inhibiting DNA repair and angiogenesis, and suppressing tumor cell activity, invasion, and metastasis. On the other hand, cetuximab can also mediate the killing of tumor cells by immune cells through antibody-dependent cell-mediated cytotoxicity (ADCC).

With its proven efficacy and favorable safety profile, cetuximab has become one of the important targeted therapies for EGFR pathway-related tumors . ^1-3 To date, cetuximab has been approved for marketing in multiple countries and regions worldwide, primarily for the treatment of metastatic colorectal cancer (mCRC) and head and neck squamous cell carcinoma (HNSCC). HLX05-N is a cetuximab biosimilar developed by Henlius Biotech in strict accordance with biosimilar guidelines in China, the European Union, and the United States. Pharmaceutical and non-clinical comparative studies have demonstrated its high similarity to the original cetuximab injection. Our company plans to conduct an international multicenter Phase I clinical trial of HLX05-N when conditions permit.

In the future, Henlius will continue to focus on unmet clinical needs, expand its forward-looking layout in more disease areas, and bring high-quality, affordable innovative treatment options to patients around the world.

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