Core Viewpoint - The approval of Daratumumab injection by the National Medical Products Administration of China marks a significant advancement for the company in the field of targeted therapies for multiple myeloma [1] Group 1: Product Development - The product is a recombinant fully human IgG1 monoclonal antibody targeting ADP-ribosyl cyclase (CD38) [1] - It is a biosimilar to the original drug, Darzalex, and has been filed under Class 3.3 for therapeutic biological products [1] - The development of the product adheres to the relevant guidelines for biosimilar research, demonstrating high similarity in quality, safety, and efficacy compared to the reference drug [1] Group 2: Clinical Trials - The approval allows the company to initiate clinical trials in China for the treatment of adult patients with multiple myeloma [1] - The results from pharmaceutical and non-clinical studies support the continuation of subsequent clinical research [1]
石药集团(01093)：达雷妥尤单抗注射液在中国获临床试验批准