CSPC PHARMA (01093): Daratumumab injection approved for clinical trials in China.

CSPC PHARMA (01093) announced that the daratumumab injection developed by the group has been approved by the National Medical Products Administration of the People's Republic of China for clinical trials in China. This product is a recombinant fully human IgG1 monoclonal antibody targeting ADP-ribosyltransferase (CD38), and is a biosimilar of the originator drug Darzalex. It has been filed under category 3.3 for biologic drug applications, and is suitable for the treatment of adult patients with multiple myeloma. The development of this product follows the principles of biosimilar-related research guidance. Results from pharmaceutical and non-clinical studies demonstrate that the product is highly similar to the reference drug in terms of quality, safety, and efficacy, supporting future clinical trials.