Henlius secures NMPA approval to initiate Phase 1 trial of cetuximab biosimilar HLX05-N for metastatic colorectal cancer

Bulletin Express04-14

Shanghai Henlius Biotech, Inc. announced that China’s National Medical Products Administration has cleared the company’s investigational new drug application for HLX05-N, a cetuximab injection biosimilar aimed at treating metastatic colorectal cancer (mCRC). The clearance allows Henlius to proceed with an international, multicenter Phase 1 clinical study once operational conditions are met.

HLX05-N is an independently developed recombinant anti-EGFR chimeric human-murine monoclonal antibody. Comparative pharmaceutical and non-clinical studies, conducted in line with biosimilar guidelines from China, the European Union and the United States, demonstrated high similarity to the reference cetuximab product. Mechanistically, the antibody binds EGFR, blocks ligand activation, inhibits downstream signaling, and can trigger antibody-dependent cellular cytotoxicity, leading to inhibited tumor growth and induced apoptosis. Target indications include colorectal cancer and head and neck squamous cell carcinoma, with efficacy confined to tumors harboring wild-type RAS.

According to IQVIA MIDAS data, global sales of cetuximab injection biosimilars reached approximately USD1.66 billion in 2025, underscoring a sizable commercial opportunity for new entrants.

Henlius cautions that the successful development and commercialization of HLX05-N are not guaranteed, and advises shareholders and potential investors to exercise prudent judgment when dealing in the company’s shares. The voluntary announcement was released on 14 April 2026.

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