On 8 July 2026, Shanghai Henlius Biotech announced that the first patient in China has been dosed in its multicentre Phase 1 clinical trial of HLX05-N, biosimilar to Eli Lilly/Merck KGaA’s Erbitux® (cetuximab).
The Phase 1 study, initiated in June 2026, is designed to evaluate the pharmacokinetic similarity, efficacy, safety and immunogenicity of HLX05-N compared with US- and EU-sourced Erbitux® in patients with metastatic colorectal cancer (mCRC). Primary completion of the study is expected in June 2027.
The FDA approved the Investigational New Drug (IND) application for the Phase 1 trial in May 2026, shortly after the approval of Henlius’ IND by China’s National Medical Products Administration in April 2026.
No cetuximab biosimilars have been launched to date in China, the United States, Europe or Japan. Alkem’s Cetuxa™ was reportedly the first cetuximab biosimilar to be approved and launched in India (January 2023 and May 2023, respectively). Alkem’s biological arm, Enzene, entered into a strategic collaboration with Lupin in May 2023 for Indian commercialisation of Cetuxa™. In February 2026, R-Pharm’s Arcetux™ (cetuximab) was the first biosimilar cetuximab to gain approval in Russia.