On 30 October 2025, Boan Biotech announced that it has completed enrolment for the clinical phase III study of its self-developed BA1104, biosimilar to BMS’ Opdivo® (nivolumab). The study is being conducted in China and is aimed at comparing the efficacy, safety, and immunogenicity of BA1104 versus Opdivo® when combined with chemotherapy for treating patients with advanced or metastatic oesophageal squamous cell carcinoma.
While Boan Biotech’s trial is reported to be the first one for a nivolumab biosimilar in China, at least Amgen, Sandoz, Xbrane/Intas, Enzene and Reliance Life Sciences also have nivolumab biosimilars in development. Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024 but has since faced injunction proceedings before the Delhi High Court.
Boan Biotech has received marketing approval in China for other biosimilars, including Boyoubei® (November 2022) and Boluojia® (May 2024), referencing Amgen’s Prolia® and Xgeva® (denosumab), respectively. In July 2024, Boan announced that it had its application for biosimilar aflibercept, BA9101, accepted for evaluation in China. Boan Biotech has also conducted trials on dulaglutide and bevacizumab biosimilars.