Core Viewpoint - The completion of patient enrollment in the Phase III clinical trial of BA1104 (Nivolumab injection) by the company marks a significant milestone, as it is the first biosimilar of Opdivo to enter Phase III trials in China [1][2] Group 1: Company Developments - BA1104 is a humanized monoclonal antibody targeting the PD-1 receptor, designed to enhance T-cell anti-tumor responses by blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2 [1] - The Phase III trial is a randomized, double-blind, multi-center study comparing the efficacy, safety, and immunogenicity of BA1104 with Opdivo in combination with chemotherapy for patients with advanced or metastatic esophageal squamous cell carcinoma [2] - The results of the completed Phase I trial indicated that BA1104 is highly comparable to Opdivo in terms of pharmacokinetics, safety, and immunogenicity, achieving all study endpoints [2] Group 2: Market Potential - The PD-1 inhibitors, including BA1104, represent a major advancement in cancer immunotherapy, with expanding clinical applications and significant market potential [2] - Opdivo is projected to generate approximately $9.3 billion in global sales in 2024 [2] - The Chinese antibody market based on PD-1/L1 is expected to reach 59.9 billion RMB by 2030, indicating substantial growth opportunities in this sector [2]
博安生物(06955)：纳武利尤单抗中国Ⅲ期临床试验完成所有患者入组