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人福醫藥(600079.SH):琥珀酸美託洛爾緩釋片獲得美國FDA批准文號
格隆匯 02-22 15:37

格隆匯 2 月 21日丨人福醫藥(600079.SH)公佈,近日,公司控股子公司宜昌人福藥業有限責任公司(“宜昌人福”,公司持有其80%的股權)美國食品藥品監督管理局(FDA)關於琥珀酸美託洛爾緩釋片的批准文號

琥珀酸美託洛爾緩釋片用於治療高血壓、心絞痛以及伴有左心室收縮功能異常的症狀穩定的慢性心力衰竭宜昌人福於2019年提交琥珀酸美託洛爾緩釋片的ANDA,累計研發投入約為190萬美元。根據IQVIA數據統計2020該藥品美國市場的總銷售額約39美元,主要生產廠商包括Dr ReddysIngenus PharmaTeva國家藥品監督管理局網站顯示琥珀酸美託洛爾緩釋片在國內僅AstraZeneca AB (阿斯利康)獲得藥品進口註冊根據米內網數據統計2019年度美託洛爾所有劑型(含琥珀酸美託洛爾酒石酸美託洛爾等)在我國城市、縣級及鄉鎮三大終端公立醫院的銷售額約為30億元人民幣,主要生產廠商阿斯利康廣州白雲山天心製藥股份有限公司常州四藥製藥有限公司等。

此次琥珀酸美託洛爾緩釋片獲得美國FDA批准文號標誌着宜昌人福具備了在美國市場銷售該產品的資格,將對公司拓展美國仿製藥市場帶來積極的影響公司後續將積極推進該產品在美國市場的上市準備工作。

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