Recently, Betta Pharmaceuticals and Shengsi Bio reached a comprehensive strategic cooperation agreement. Betta Pharmaceuticals will provide support to Shengsi Bio across R&D, clinical development, manufacturing, registration, and sales & marketing to facilitate the R&D, industrialization, and commercialization of related products. Additionally, the two companies signed a commercial cooperation agreement granting Betta Pharmaceuticals exclusive distribution rights for FRSW117 (a long-acting recombinant coagulation factor VIII-Fc fusion protein for injection) in the Greater China region (including Mainland China, Hong Kong, Macau, and Taiwan).

Hemophilia is an X-linked recessive inherited bleeding disorder, primarily classified into hemophilia A (HA) and hemophilia B (HB), caused by deficiencies in coagulation factor VIII (FVIII) and coagulation factor IX (FIX), respectively. According to China's "Guidelines for the Diagnosis and Treatment of Hemophilia A (2022 Edition)" and the "China Hemophilia Diagnosis and Treatment Report 2023," the prevalence of hemophilia in China is approximately 2.73-3.09 per 100,000 population, with HA accounting for 80%-85% and HB accounting for 15%-20%. Hemophilia was included in China's first "Rare Disease Catalog" in 2018. According to Frost & Sullivan data, the number of hemophilia patients in China is currently estimated at approximately 140,000, and the hemophilia drug market is expected to reach RMB 14.1 billion by 2030.

Factor replacement therapy is currently the primary treatment for hemophilia. The drug of choice for HA replacement therapy is recombinant FVIII or virally inactivated plasma-derived FVIII. To date, three domestic recombinant factor VIII products have been approved for marketing in China, all of which are conventional recombinant factor VIII with a prophylaxis dosing frequency of three times per week or every other day. FRSW117, the subject of this commercialization cooperation, is a long-acting recombinant factor VIII, classified as a Class 1 therapeutic biologic product. It has recently completed a Phase III clinical trial and is intended for routine prophylaxis, on-demand treatment, and perioperative bleeding management in patients with HA, with a dosing frequency of once weekly for prophylaxis. To date, no domestic long-acting recombinant factor VIII product has been approved for marketing in China.