Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a China-based pharmaceutical company, has announced that it has received another clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 biologic, STSP-0601. The approval is for the on-demand treatment of bleeding in patients with hemophilia A or B who do not have inhibitors.
Mechanism of STSP-0601
STSP-0601 is a coagulation factor X activator isolated and purified from Viper venom. The drug specifically activates FX, fully exposing the active site to generate FXa. This active form then forms a prothrombin complex with activated platelets, FVa, and calcium ions at the injury site, thereby increasing thrombin generation and promoting hemostasis.
Clinical Development and Milestones
STSP-0601 completed a Phase I clinical study in August 2021, demonstrating a good safety and tolerability profile for the on-demand treatment of bleeding in patients with hemophilia A or B who have inhibitors. Building on these results, a Phase II clinical study has been initiated. The drug also earned a breakthrough therapy designation (BTD) in August of this year, highlighting its potential to address significant unmet needs in hemophilia treatment.-Fineline Info & Tech
