On May 10, 2026, Shanghai Henlius Biotech, Inc. (2696.HK) announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for HLX05-N, Henlius' self-developed biosimilar of cetuximab (The recombinant anti-EGFR human/murine chimeric monoclonal antibody), for the treatment of metastatic colorectal cancer (mCRC). Recently, the IND application for a Phase 1 clinical trial of HLX05-N for the treatment of mCRC has also been approved by the National Medical Products Administration (NMPA) in China.

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, includingcolorectal 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).According to IQVIA MIDAS™ data, the global sales of cetuximab injection reached approximately USD 1.658 billion in 2025, reflecting the well-established clinical use of EGFR-targeted therapies and the sustained market demand in related tumor areas.

Although EGFR-targeted therapies are widely used across relevant tumor types, disparities in access and affordability persist worldwide, underscoring the need for more high-quality, cost-effective treatment options. To date, no biosimilars of cetuximab have been approved in the U.S. or Europe, and the overall competitive landscape remains at an early stage. Against this backdrop, the continued development of therapies with reliable efficacy and enhanced accessibility is expected to expand patient access and benefit a broader population. 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.

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.