九洲药业添新品 甲苯磺酸艾多沙班获批

Core Viewpoint - Zhejiang Jiuzhou Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the marketing application of Tofisopam, an oral anticoagulant drug, which will enhance the company's product portfolio and market competitiveness [1][1][1] Summary by Relevant Sections Product Approval - The company has obtained the "Chemical Raw Material Drug Marketing Application Approval Notice" for Tofisopam, indicating compliance with national drug registration requirements [1][1] - The drug is primarily used for preventing strokes and systemic embolism in patients with non-valvular atrial fibrillation, as well as for treating or preventing deep vein thrombosis and pulmonary embolism [1][1] Market Potential - In 2023, the sales revenue of Tofisopam in domestic sample hospitals and retail pharmacies was approximately 361 million yuan [1][1] - The company submitted the marketing application to the Center for Drug Evaluation in July 2024 and has invested about 6.69 million yuan in the research and development of Tofisopam to date [1][1] Strategic Impact - The approval of Tofisopam is expected to enrich the company's product structure and enhance its market competitiveness [1][1]