Jiangsu Beijietai：Bemiltenase Alfa approved for marketing in China
The Category 1 new drug Bemiltenase Alfa for injection, developed by Staidson’s subsidiary Jiangsu Beijietai Biotechnology Co., Ltd., has been granted conditional marketing approval.
Bemiltenase Alfa for injection is a global first-in-class coagulation Factor X activator (a domestic Category 1 novel biologic drug) independently developed by Jiangsu Beijietai Biotechnology Co., Ltd. with full intellectual property rights. It is indicated for the on-demand treatment of bleeding in hemophilia A or B with inhibitors, filling the gap in high-end hemophilia treatment in China.
The drug was accepted by the CDE in May 2025 and was included in the priority review list based on criteria such as “an innovative drug for rare diseases, a drug included in the Breakthrough Therapy Designation program, and a drug eligible for conditional approval.” Subsequently, it received conditional marketing approval from the NMPA in June of this year.
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