Group 1 - The core point of the article is that Bohan Biotech (06955) has seen its stock price increase by over 4% following the completion of patient enrollment in the Phase III clinical trial for its drug BA1104 (Nivolumab injection) in China [1] - As of the report, Bohan Biotech's stock is trading at 10.48 HKD with a transaction volume of 45.98 million HKD [1] - BA1104 is the first biosimilar of Opdivo (Nivolumab) to enter Phase III clinical trials in China, indicating a significant milestone for the company [1] Group 2 - The Phase III clinical trial for BA1104 is a randomized, double-blind, multi-center study aimed at comparing the efficacy, safety, and immunogenicity of BA1104 combined with chemotherapy against Opdivo in patients with advanced or metastatic esophageal squamous cell carcinoma [1] - The results from the completed Phase I clinical trial show that BA1104 is highly comparable to Opdivo in terms of pharmacokinetics, safety, and immunogenicity, achieving all study endpoints [1] - The research results from the Phase I trial have been published in the international journal "BioDrugs," further validating the drug's development progress [1]

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]

Core Viewpoint - The company has completed patient enrollment for the Phase III clinical trial of BA1104 (Nivolumab Injection) in China, making it the first biosimilar of Opdivo to enter Phase III trials domestically [1][2] Company Summary - BA1104 is a humanized monoclonal antibody (IgG4 subtype) targeting the programmed cell death protein 1 (PD-1) receptor, enhancing 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 combined with chemotherapy against Opdivo in patients with advanced or metastatic esophageal squamous cell carcinoma [2] - The completed Phase I trial results indicate that BA1104 is highly comparable to Opdivo in terms of pharmacokinetics, safety, and immunogenicity, achieving all study endpoints, with results published in the international journal "BioDrugs" [2] Industry Summary - PD-1 inhibitors represent a major approach in cancer immunotherapy, with ongoing breakthroughs in combination therapies and the synergistic development of diverse immunotherapies expanding their clinical application boundaries [2] - The global sales of Opdivo are projected to reach approximately $9.3 billion in 2024 [2] - According to a Frost & Sullivan report, the market size for PD-1/L1 antibodies in China is expected to reach 59.9 billion RMB by 2030 [2]