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上海医药(02607):替格瑞洛片的 ANDA 获得美国 FDA 批准
智通财经网·2025-11-06 09:37

Core Viewpoint - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory, has received final approval from the U.S. FDA for its abbreviated new drug application (ANDA) for Ticagrelor tablets, which is significant for expanding the company's overseas market presence and gaining valuable experience [1]. Summary by Relevant Sections - Product Approval - The U.S. FDA has granted final approval for Changzhou Pharmaceutical Factory's ANDA for Ticagrelor tablets, which are used to reduce the incidence of thrombotic cardiovascular events in patients with acute coronary syndrome [1]. - Background Information - Ticagrelor was originally developed by AstraZeneca and was launched in the U.S. in 2011. The ANDA application was submitted by Changzhou Pharmaceutical Factory in May 2021 [1]. - Financial Investment - The company has invested approximately RMB 9.6713 million in the research and development of this drug as of the date of the announcement [1]. - Market Implications - The approval of Ticagrelor tablets is expected to positively impact the company's efforts to expand into international markets and enhance its operational experience [1].