On 14 April 2026, Shanghai Henlius Biotech announced that China’s National Medical Products Administration (NMPA) has approved an Investigational New Drug (IND) application for HLX05-N, biosimilar to Eli Lilly/Merck KGaA’s Erbitux® (cetuximab), for the treatment of metastatic colorectal cancer (mCRC).
According to Henlius, it now plans to commence an international multicentre Phase 1 clinical study of HLX05-N “once the necessary conditions are met”.
Other cetuximab biosimilars have been approved globally, primarily for the treatment of mCRC and head and neck squamous cell carcinoma (HNSCC). Alkem’s Cetuxa™ was reportedly the first cetuximab biosimilar to be approved and launched, having been approved in India in January 2023 and launched in May 2023. Alkem’s biological arm, Enzene, entered into a strategic collaboration with Lupin in May 2023 for Indian commercialisation of Cetuxa™. Simcere Zaiming/Mabpharm’s Enlituo® (cetuximab beta) was approved in China in June 2024. In February 2026, R-Pharm’s Arcetux™ (cetuximab) was the first biosimilar cetuximab to gain approval in Russia.