Shutai God: Injection STSP-0601 included in priority review process.

Shutai Shen Announcement: The injectable product STSP-0601 of its subsidiary, Jiangsu Beijetai Biotechnology Co., Ltd., was included in the list of products to be prioritized for review by the National Medical Products Administration Drug Evaluation Center on May 26, 2025. It was officially included in the priority review process on June 5, 2025. The injectable STSP-601 is a Class 1 therapeutic biological product in the country, used for on-demand treatment of bleeding in patients with hemophilia A or B with inhibitors. The drug started phase Ib/II clinical trials in patients with hemophilia with inhibitors in September 2021 and received breakthrough therapy designation in September 2022. In March 2024, a phase IIb clinical trial for on-demand treatment of bleeding in hemophilia patients with inhibitors was initiated, and the results showed significant efficacy in on-demand treatment of bleeding.