Shensi Bio announced today (April 29, 2026) that its independently developed Pegylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (project code: FRSW117) has been submitted for marketing authorization to the National Medical Products Administration (NMPA) and has officially been accepted for review. FRSW117 is a world-first, ultra-long-acting recombinant Factor VIII product that combines two half-life extension technologies—Fc fusion and PEGylation. It is intended for routine prophylactic treatment, on-demand replacement therapy, and perioperative bleeding management in patients with hemophilia A, with a dosing frequency of once weekly for routine prophylaxis.
Hemophilia A is an X-linked recessive inherited bleeding disorder caused by a deficiency of coagulation Factor VIII, characterized by delayed, persistent, and slow bleeding. According to hemophilia prevalence survey data in China, hemophilia A accounts for approximately 80% to 85% of all hemophilia cases. Currently, the mainstay therapies in China include plasma-derived Factor VIII and recombinant Factor VIII, both of which share the common drawback of a short half-life. To maintain optimal treatment outcomes, patients require intravenous injections at least once every two days. NovoEight®, a PEGylated long-acting recombinant Factor VIII already available in China, has reduced dosing frequency to once every four days through half-life extension technology, yet it still falls short of meeting patient demand for even lower-frequency dosing.
By synergistically combining two technology platforms—Fc fusion protein and PEGylation—FRSW117 significantly extends the half-life of Factor VIII in the body. While ensuring efficacy and safety, it reduces dosing frequency for routine prophylactic treatment from once every two days to once weekly, offering a brand-new treatment option for hemophilia A patients in China. Moreover, FRSW117 has demonstrated annualized bleeding rates, annualized joint bleeding rates during routine prophylaxis, and hemostatic efficacy rates for on-demand treatment that meet or exceed the average levels of similar products.
The acceptance of FRSW117's marketing application marks another major milestone for Shensi Bio in the field of hemophilia treatment. The company will actively cooperate with the national drug regulatory authorities throughout the review and approval process, striving to bring FRSW117 to market as soon as possible for the benefit of hemophilia A patients.
As a steadfast partner standing alongside Shensi Bio, Yifeng Capital will continue to focus on global frontier biotechnology sectors, deeply identify high-quality targets with true clinical value and innovative potential, leverage capital to support the R&D of domestic innovative drugs, persistently drive therapeutic innovation in major disease areas, and bring more breakthrough treatments to patients.