上海莱士(002252.SZ)：SR604注射液新增适应症获得药物临床试验批准

Core Viewpoint - Shanghai Raas has received approval from the National Medical Products Administration for clinical trials of SR604 injection for the prevention of bleeding episodes in patients with von Willebrand disease [1][2] Group 1: Clinical Trial Approval - The National Medical Products Administration issued a clinical trial approval notice for SR604 injection, which is a humanized monoclonal antibody that specifically inhibits the anticoagulant function of human activated protein C [1] - The clinical trial application for the indication of preventing bleeding episodes in patients with hemophilia A/B and congenital factor VII deficiency was accepted on December 21, 2023, and the approval notice was received on March 5, 2024 [1] Group 2: Drug Characteristics and Research Progress - SR604 injection is designed to improve the treatment experience for patients with von Willebrand disease, a hereditary bleeding disorder caused by abnormalities in von Willebrand factor [2] - The company has completed a single-dose escalation Phase I trial and is now entering a multi-dose Phase IIb trial, with results expected to be published in international conferences and professional journals [1][2] - There are currently no products on the market targeting the same mechanism as SR604, and no antibody drugs have been approved for the prevention of bleeding in von Willebrand disease [2]