Shanghai RAAS’s SR604 injection approved for new VWD clinical trial

Shanghai RAAS Blood Products Co. announced that its SR604 injection received approval from the National Medical Products Administration (NMPA) for a new clinical trial indication: the prophylactic treatment of bleeding episodes in patients with von Willebrand disease (VWD). The company received the "Drug Clinical Trial Approval Notice" on August 22, 2025. This approval is for a Class 1 therapeutic biological product manufactured domestically.

The newly approved clinical trial will explore multiple dosing intervals for SR604 in VWD patients, with proposed doses of 0.2mg/kg every four weeks and 0.4mg/kg every four, six, or eight weeks. SR604 injection had previously secured NMPA approval on March 5, 2024, for clinical trials targeting the prophylactic treatment of bleeding episodes in patients with hemophilia A/B and congenital factor VII deficiency, with ongoing Phase IIb trials.

Currently, there are no other products with the same target on the market globally, nor are there any approved antibody drugs for the prophylactic treatment of von Willebrand disease. The company noted that drug development is a lengthy and complex process, subject to various unpredictable factors and market competition.