On 16 July 2026, Shanghai Henlius Biotech announced that the first patient in China has been dosed in its international multicentre Phase 1 clinical trial of HLX18, biosimilar to BMS’ Opdivo® (nivolumab).
Henlius received approval from China’s National Medical Products Administration for the investigational new drug (IND) application for HLX18 in March 2026. This followed FDA approval of the HLX18 IND application in December 2025.
The Phase 1 study, initiated in June 2026, is designed to evaluate the similarity in pharmacokinetic profile, efficacy, safety and immunogenicity of HLX18 and BMS’ Opdivo® in patients with resected oesophageal or gastroesophageal junction cancer, melanoma or urothelial carcinoma. Primary completion of the study is expected in August 2027.
Nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, NeuClone’s candidate and Zydus’ ZRCr-4276. In June 2026, Orion Pharma announced it entered into an agreement with Shilpa Biologicals for the European commercialisation of Shilpa’s intravenous nivolumab biosimilar, which is currently under development.
Zydus’ Tishtha™ was the first nivolumab biosimilar to be launched in the world when it became available in India in January 2026 (approved July 2024), following the High Court of Delhi’s 12 January 2026 reversal on appeal of a preliminary injunction granted to BMS in relation to the biosimilar.