CSPC Group (01093): Daretuizumab injection approved for clinical trials in China

Zhitongcaijing · 2d ago

According to the Zhitong Finance App, Shiyao Group (01093) issued an announcement that the daretuizumab injection developed by the Group has been approved by the China Drug Administration and can conduct clinical trials in China.

This product is a recombinant all-human IgG1 monoclonal antibody targeting ADP-ribosyl cyclase (CD38). It is a biosimilar of the original drug Zhaoke®. It is suitable for the treatment of adult patients with multiple myeloma according to Class 3.3 of therapeutic biological products.

The product was developed in accordance with biosimilar research guidelines. Pharmaceutical and non-clinical study results showed that the product was highly similar to the original reference drug in terms of quality, safety, and efficacy, and supported subsequent clinical studies.