Shanghai, China, 8 July, 2026 – Shanghai Henlius Biotech, Inc. (2696.HK) today announced that the first patient has been dosed in China in the phase 1 clinical trial (HLX05-N-mCRC102) of its independently  developed cetuximab biosimilar, HLX05-N (recombinant anti-EGFR human-mouse chimeric monoclonal antibody injection), for the treatment of metastatic colorectal cancer (mCRC). Previously, the Investigational New Drug (IND) application for the phase 1 clinical trial of HLX05-N in mCRC had also been cleared by the U.S. Food and Drug Administration (FDA). To date, no cetuximab biosimilar has been approved in China or other major global biologics markets, including the United States, Europe, and Japan.

HLX05-N is being developed as a biosimilar to cetuximab in accordance with biosimilar regulatory guidelines in China, the European Union, and the United States. Comprehensive analytical and non-clinical comparability studies have demonstrated a high degree of similarity between HLX05-N and the reference cetuximab injection.

The epidermal growth factor receptor (EGFR) is a transmembrane glycoprotein expressed on normal epithelial cells as well as a variety of tumor types, including colorectal cancer and head and neck cancer. Cetuximab specifically binds to EGFR on the cell surface, competitively blocking the binding of endogenous ligands such as epidermal growth factor (EGF). This leads to receptor internalization and downregulation of EGFR expression, inhibits tyrosine kinase-dependent phosphorylation and downstream signaling pathways, thereby suppressing tumor cell proliferation, inducing apoptosis, and inhibiting DNA repair, angiogenesis, tumor cell invasion, and metastasis. In addition, cetuximab exerts antitumor activity through antibody-dependent cell-mediated cytotoxicity (ADCC), enabling immune cells to eliminate tumor cells.

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^™, global sales of cetuximab reached approximately US$1.658 billion in 2025, reflecting the well-established clinical value of EGFR-targeted therapies and sustained market demand in these disease areas.

Looking ahead, Henlius will continue to focus on unmet medical needs, leveraging its integrated global R&D and clinical development capabilities to expand its presence across therapeutic areas and deliver more treatment options to patients worldwide.