On 25 November 2025, Shanghai Henlius announced that the first subject has been dosed in a phase I multi-centre clinical trial of its ipilimumab biosimilar, HLX13, referencing BMS’ Yervoy®.
The investigational new drug applications under trial have been approved by the US FDA and China’s National Medical Products Administration (NMPA) (September 2025) as a first-line treatment for patients with unresectable hepatocellular carcinoma. Henlius’ previous preclinical studies demonstrated a high similarity or no significant difference between HLX13 and the reference product, BMS’ Yervoy®.
In April 2025, Henlius entered into a global collaboration agreement with Sandoz for the commercialisation of HLX13. Under the agreement, Henlius will develop and manufacture the biosimilar, HLX13, while Sandoz has the exclusive commercialisation rights in the US, Europe, Canada, Japan and Australia. Henlius will receive an upfront payment of USD 31 million, and up to USD 270 million in milestone payments.