上海莱士(002252.SZ)：“SR604注射液”新增临床试验适应症申请获得受理

Core Viewpoint - Shanghai RAAS has received the acceptance notice from the National Medical Products Administration for the clinical trial application of SR604 injection for the indication of "prevention of bleeding episodes in patients with von Willebrand disease" [1] Company Summary - The SR604 injection is a humanized high-affinity monoclonal antibody that specifically inhibits the anticoagulant function of human activated protein C [1] - The application for clinical trials is based on previous studies related to hemophilia, aiming to conduct a Phase II dose-exploration trial for patients with von Willebrand disease [1] - The trial will include multiple dosing intervals, with groups receiving 0.2 mg/kg every 4 weeks and 0.4 mg/kg every 4, 6, or 8 weeks [1] - If successful, this product is expected to significantly improve the medication experience for patients with von Willebrand disease [1] Industry Summary - As of the announcement date, there are no products on the market targeting the same mechanism as SR604, and no antibody drugs have been approved for the prevention treatment of von Willebrand disease [1]