ChinaBiotech & Genomic Medicine▲
Staidson subsidiary STSP-0601 receives US FDA clinical trial approval
Staidson subsidiary Jiangsu Beijietai Biotechnology Co., Ltd. has received a formal letter from the US FDA approving the initiation of a clinical trial for STSP-0601, also known as injectable pomitemase alfa under the trade name Bojianing, for the treatment of bleeding in hemophilia A or B patients with inhibitors. STSP-0601 is a national Class 1 therapeutic biological product. It has previously completed Phase Ib/II and Phase IIb clinical studies in China for hemophilia patients with inhibitors, received orphan drug designation from the US FDA in September 2022, and obtained a drug registration certificate in June 2026. The company stated that receiving FDA clinical trial approval is a milestone, but there are many uncertainties regarding subsequent clinical trials and whether the product can be approved for marketing, and it will not have a significant impact on the company's current performance.