Core Viewpoint - The announcement indicates that CSPC Pharmaceutical Group Limited has received approval from the National Medical Products Administration of China to conduct clinical trials for Dupilumab Injection, a monoclonal antibody drug targeting IL-4Rα, which is a biosimilar to Dupixent [1] Group 1: Product Development - The product is a recombinant fully human monoclonal antibody drug designed for the treatment of moderate to severe atopic dermatitis in adults [1] - The development of the product follows the relevant research guidelines for biosimilars, ensuring compliance with regulatory standards [1] Group 2: Research Findings - Pharmaceutical and non-clinical research results demonstrate that the product is highly similar to the reference drug in terms of quality, safety, and efficacy, supporting the initiation of subsequent clinical studies [1]
石药集团：度普利尤单抗注射液在中国获临床试验批准