辰欣藥業(603367.SH):艾司奧美拉唑鎂腸溶膠囊獲美國FDA批准上市
格隆匯10月9日丨辰欣藥業(603367.SH)公佈,近日,公司收到美國食品藥品監督管理局(US Food and Drug Administration,以下簡稱“美國FDA”)的通知,公司向美國FDA申報的艾司奧美拉唑鎂腸溶膠囊簡略新藥申請(Abbreviated New Drug Application,即美國仿製藥申請)已獲得批准。
艾司奧美拉唑(曾用名埃索美拉唑)是奧美拉唑的單一異構體,屬於質子泵抑制劑,能有效一致胃酸分泌,臨牀上用於治療胃食管反流性疾病、糜爛性反流性食管炎等。艾司奧美拉唑鎂腸溶膠囊由ASTRAZENECA研發,於2001年在美國上市。目前,在美國境內,艾司奧美拉唑鎂腸溶膠囊的主要生產企業包括HORIZON、MYLAN等。2019年,艾司奧美拉唑鎂腸溶膠囊在美國市場銷售額約8.7億美元。
截止目前,公司在艾司奧美拉唑鎂腸溶膠囊上已投入研發費用約779萬元人民幣。
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