CSPC Pharma (01093): Amicazumab injection (SYS 6053) approved for clinical trials in China.

CSPC PHARMA (01093) announced that the company's developed Emicizumab Injection (SYS 6053) has received approval from the China National Medical Products Administration for conducting clinical trials in China. This product is a modified bispecific humanized IgG4 monoclonal antibody that can bridge coagulation factors IXa and X. It is a biosimilar to Shuyouli and is classified as a class 3.3 therapeutic biological product for the treatment of hemophilia A patients. Furthermore, the development of this product follows the guidelines for biosimilars. Pharmaceutical and non-clinical research results have shown that this product is highly similar to the reference drug in terms of quality, safety, and efficacy, supporting the continuation of clinical trials.