CSPC PHARMA (01093) Receives Clinical Trial Approval in China for Emicizumab Injection (SYS 6053)

Stock News03-04 19:38

CSPC Pharmaceutical Group Limited (01093) has announced that the Emicizumab Injection (SYS 6053), developed by the group, has received approval from China's National Medical Products Administration to commence clinical trials in the country. The product is a modified bispecific humanized IgG4 monoclonal antibody capable of bridging coagulation factor IXa and factor X. It is a biosimilar to the innovative drug Hemlibra® and was filed as a therapeutic biological product under category 3.3, intended for the treatment of patients with hemophilia A. Furthermore, the development of this product adheres to the relevant biosimilar guidelines. Results from pharmaceutical and non-clinical studies indicate that the product is highly similar to the reference innovator drug in terms of quality, safety, and efficacy, supporting the progression to subsequent clinical research.

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