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

Epidermal growth factor receptor (EGFR) is a member of the ErbB family of cell surface receptors with intrinsic tyrosine kinase activity. It is a transmembrane glycoprotein widely expressed in normal epithelial cells as well as in tumor tissues, including colorectal cancer and head and neck cancers. EGFR-mediated signaling pathways regulate tumor growth through multiple mechanisms and play a key regulatory role in tumor cell proliferation, differentiation, survival, and metastasis, and are therefore considered an important therapeutic target in related tumors.

Cetuximab specifically binds to EGFR on the surface of cells. On one hand, it competitively inhibits the binding of ligands such as EGF to EGFR, inducing receptor internalization and downregulating its surface expression, thereby blocking tyrosine kinase-dependent phosphorylation and multiple intracellular signaling pathways. This leads to inhibition of cell proliferation, induction of apoptosis, and suppression of DNA repair and angiogenesis, ultimately inhibiting tumor cell activity, invasion, and metastasis. On the other hand, cetuximab can also mediate antibody-dependent cellular cytotoxicity (ADCC), enabling immune cells to kill tumor cells.

With its well-established 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 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 in strict accordance with biosimilar guidelines in China, the European Union, and the United States. Analytical and non-clinical comparative studies have demonstrated a high degree of similarity between HLX05-N and the reference cetuximab injection. Henlius plans to initiate an international multi-center Phase 1 clinical study of HLX05-N once conditions are met.

Looking forward, Henlius will maintain its focus on unmet medical needs and further broaden the company’s layout in more disease areas, commit to bring high quality and affordable treatments for patients worldwide.

References

1. NMPA Package Insert for Erbitux®

2. erbitux-epar-product-information https://www.ema.europa.eu/en/documents/productinformation/erbitux-epar-product-information_en.pdf

3. FDA ERBITUX product information https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125084s279lbl.pdf