Shandong Boan Biotechnology Co., Ltd. (the “Company”) announced the completion of patient enrollment for a Phase III clinical trial of its nivolumab injection, BA1104, in the People’s Republic of China. The investigational therapy is described as the first biosimilar of Opdivo® in China to progress to a Phase III clinical trial.
Nivolumab is a humanized monoclonal antibody blocking the interaction between the PD-1 receptor and its ligands, aiming to enhance T-cell-mediated anti-tumor responses. BA1104 has been developed according to guidelines for biosimilars and is undergoing a randomized, double-blind, multicenter Phase III study comparing its efficacy, safety, and immunogenicity to Opdivo® plus chemotherapy in patients with advanced or metastatic esophageal squamous cell carcinoma. In line with Chinese regulatory guidelines, the Company may apply for approval of BA1104 for all indications that Opdivo® has obtained in China upon completion of the Phase III trial. Prior Phase I data showed that BA1104 is highly comparable to Opdivo® in pharmacokinetics, safety, and immunogenicity, and related results have appeared in BioDrugs.
Immunotherapies such as PD-1 inhibitors have become a mainstay in cancer treatment. According to publicly available data, worldwide sales of Opdivo® reached approximately USD 9.3 billion in 2024. A Frost & Sullivan report estimates that China’s PD-1 and PD-L1 inhibitor market could reach RMB59.9 billion by 2030, reflecting the growing potential for such treatments in oncology.
According to the announcement, the executive directors of Shandong Boan Biotechnology are Ms. Jiang Hua (also serving as Chairlady and Chief Executive Officer), Dr. Dou Changlin, and Mr. Wang Shenghan. The non-executive directors are Mr. Liu Yuanchong, Ms. Li Li, and Mr. Li Shixu, and the independent non-executive directors are Professor Shi Luwen, Mr. Dai Jixiong, and Dr. Yu Jialin. The announcement is dated 30 October 2025 in Yantai, the People’s Republic of China.
Comments