Jiangsu Beijie Tai Biotechnology Co., Ltd., a subsidiary of Sutai Shen, has recently received notification from the National Medical Products Administration (NMPA) acknowledging the acceptance of its registration and conditional marketing authorization application for the domestic production of "STSP-0601 Injection." This innovative drug is specifically formulated to expedite hemostasis and is indicated for the on-demand treatment of adult patients diagnosed with inhibitor-associated hemophilia A or B. Categorized as a Class 1 therapeutic biological product, it represents a significant advancement in the field of hemophilia treatment.
While the company has successfully completed numerous clinical trials and obtained comprehensive summary reports, it cautions that there remains a degree of uncertainty regarding the ultimate granting of full production approval and marketing authorization by the NMPA.