注射用阿替普酶
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天士力医药集团股份有限公司关于全资子公司注射用重组人尿激酶原增加急性缺血性脑卒中新适应症获得药品注册证书的公告
Shang Hai Zheng Quan Bao· 2025-09-22 18:51
Core Viewpoint - Tian Shi Li Pharmaceutical Group's subsidiary has received approval for a new indication of its recombinant human urokinase for the treatment of acute ischemic stroke, enhancing its product line and market competitiveness [1][3]. Group 1: Drug Information - The drug, recombinant human urokinase (brand name: Pu You Ke), is now approved for thrombolytic treatment of acute ischemic stroke [1]. - It is a first-class biological innovative drug supported by the national "Major New Drug Creation" project during the "11th Five-Year Plan" [1]. - The drug has a specific mechanism that preferentially activates plasminogen on the surface of fibrin, targeting occlusive thrombus while minimizing the risk of bleeding [2]. Group 2: Clinical and Market Impact - The drug's Phase III clinical results indicate that it is non-inferior to the control group for patients with acute ischemic stroke when administered within 4.5 hours of onset, while significantly reducing the risk of intracranial hemorrhage [2]. - The total R&D investment for the acute ischemic stroke indication has reached approximately 32.93 million RMB [3]. - The approval of this new indication expands the company's product offerings in the neurological and psychiatric fields, potentially increasing its market share and competitiveness [3].