上海莱士血液制品股份有限公司 关于“SR604注射液”新增适应症获得药物临床试验批准通知书的公告

Core Viewpoint - Shanghai Laishi Blood Products Co., Ltd. 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][3]. Drug Development Related Information - SR604 injection is a humanized monoclonal antibody that specifically inhibits the anticoagulant function of human activated protein C, classified as a Class 1 therapeutic biological product [2]. - The clinical trial application for SR604 injection targeting bleeding episodes in patients with von Willebrand disease was accepted on December 21, 2023, and the approval notice was received on March 5, 2024 [2]. - The drug has completed the single-dose escalation Phase I trial and is now entering the multiple-dose prevention treatment efficacy exploration Phase IIb trial, with results expected to be published in international conferences and professional journals [2]. Clinical Trial Details - The newly approved clinical trial for SR604 injection will explore dosing intervals of 0.2 mg/kg every 4 weeks and 0.4 mg/kg every 4, 6, or 8 weeks for patients with von Willebrand disease [3]. - There are currently no products on the market targeting the same mechanism as SR604 injection, and no antibody drugs have been approved for the prevention of bleeding in von Willebrand disease [3].