華海藥業(600521.SH):琥珀酸美託洛爾緩釋片、賽洛多辛膠囊獲美FDA批准文號
格隆匯1月6日丨華海藥業(600521.SH)公佈,近日,公司收到美國食品藥品監督管理局(簡稱“美國FDA”)的通知,公司向美國FDA申報的琥珀酸美託洛爾緩釋片、賽洛多辛膠囊的新藥簡略申請(ANDA,即美國仿製藥申請,申請獲得美國FDA審評批准意味着申請者可以生產並在美國市場銷售該產品)已獲得批准。
琥珀酸美託洛爾緩釋片主要用於治療高血壓,心絞痛,伴有左心室收縮功能異常的症狀穩定的慢性心力衰竭。琥珀酸美託洛爾緩釋片由AstraZeneca研發,最早於1992年上市。當前,美國境內,琥珀酸美託洛爾緩釋片的主要生產廠商有Reddys、Viatris、Ingenus等;國內生產廠商主要有浙江普洛康裕製藥有限公司、海南華益泰康藥業有限公司等。2020年該藥品美國市場銷售額約1.31億美元(數據來源於IMS數據庫)。
截至目前,公司在琥珀酸美託洛爾緩釋片項目上已投入研發費用約637萬元人民幣。
賽洛多辛膠囊主要用於改善良性前列腺增生症(BHP)引起的症狀和體徵。賽洛多辛膠囊由Allergan研發,最早於2008年上市。當前,美國境內,賽洛多辛膠囊的主要生產廠商有Lupin、Ajanta、Aurobindo等;國內生產廠商有第一三共製藥(北京)有限公司、上海匯倫江蘇藥業有限公司、海南萬瑋製藥有限公司。2020年該藥品美國市場銷售額約2043.06萬美元(數據來源於IMS數據庫)。
截至目前,公司在賽洛多辛膠囊項目上已投入研發費用約487萬元人民幣。
該次琥珀酸美託洛爾緩釋片、賽洛多辛膠囊獲得美國FDA批准文號標誌着公司具備了在美國市場銷售該產品的資格,上述產品ANDA文號的獲取有利於公司不斷擴大美國市場銷售,強化產品供應鏈,豐富產品梯隊,提升公司產品的市場競爭力,對公司的經營業績產生積極的影響。
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