上海莱士：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, specifically for its use in preventing bleeding episodes in patients with von Willebrand disease [1] - The clinical trial application for SR604 was submitted under the classification of therapeutic biological products and was accepted on December 21, 2023, with the approval notice received on March 5, 2024 [1] Group 2: Drug Mechanism and Development - SR604 injection is a humanized monoclonal antibody that specifically inhibits the anticoagulant function of human activated protein C [1] - The drug has completed a single-dose escalation Phase I trial and has entered a multi-dose Phase IIb trial, with results meeting the clinical trial design goals [1] Group 3: Market Potential - The approved clinical trial for SR604 focuses on the prevention of bleeding episodes in patients with von Willebrand disease, a hereditary bleeding disorder caused by abnormalities in von Willebrand factor [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] - Successful development of SR604 is expected to significantly improve the treatment experience for patients with von Willebrand disease [2]