Core Viewpoint - The announcement indicates that the drug Daratumumab injection developed by the company has received approval from the National Medical Products Administration of the People's Republic of China to conduct clinical trials in China [1] Group 1: Product Information - The product is a recombinant fully human IgG1 monoclonal antibody targeting ADP-ribosyl cyclase (CD38) and is a biosimilar to the original drug Darzalex [1] - It is classified under Category 3.3 for therapeutic biological products and is intended for the treatment of adult patients with multiple myeloma [1] Group 2: Research and Development - The development of the product follows the relevant research guidelines for biosimilars, and the pharmaceutical and non-clinical research results indicate that the product is highly similar to the reference drug in terms of quality, safety, and efficacy [1] - These findings support the initiation of subsequent clinical research [1]
石药集团：达雷妥尤单抗注射液在中国获临床试验批准