Shanghai RAAS(SZ:002252) Zheng Quan Zhi Xing·2025-08-25 16:34Core Viewpoint - Shanghai Laishi Blood Products Co., Ltd. has received acceptance from the National Medical Products Administration for a clinical trial application for the new indication of SR604 injection for the prevention of bleeding episodes in patients with von Willebrand disease [1][2]. Group 1: Clinical Trial Application Details - The drug name is SR604 injection, with a specification of 30mg (1mL) per bottle, and the acceptance number is CXSL2500733, received on August 22, 2025 [1]. - The application is for a clinical trial to be conducted domestically, classified as a Class 1 therapeutic biological product [1]. - The existing clinical trial indications include the prevention of bleeding episodes in patients with Hemophilia A/B and congenital factor VII deficiency [1]. Group 2: Drug Characteristics and Market Potential - SR604 injection is a humanized monoclonal antibody that specifically inhibits the anticoagulant function of human activated protein C [1]. - The new application targets the prevention of bleeding episodes in patients with von Willebrand disease, which is 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, nor have any antibody drugs been approved for the prevention of bleeding in von Willebrand disease [2]. Group 3: Future Development Plans - The company plans to conduct a Phase II dose-exploration trial with dosing regimens of 0.2mg/kg every 4 weeks and 0.4mg/kg every 4, 6, or 8 weeks [2]. - The new indication's clinical trial application will not affect the ongoing trials for the original indications [3].