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華海藥業(600521.SH):左乙拉西坦注射液、非布司他片獲得美國FDA批准文號
格隆匯 03-31 17:51

格隆匯3月31日丨華海藥業(600521.SH)公佈,近日,公司收到美國FDA的通知,公司向美國FDA申報的左乙拉西坦注射液、非布司他片的新藥簡略申請(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。

左乙拉西坦注射液主要用於治療癲癇。左乙拉西坦注射液由UCB研發,最早於2006年在美國上市。當前,美國境內,左乙拉西坦注射液的主要生產廠商有Viatris、Aurobindo、Hikma等;左乙拉西坦注射劑國內生產廠商主要有江蘇萬高藥業股份有限公司、海南普利製藥股份有限公司等。2021年該藥品美國市場銷售額約1300.62萬美元(數據來源於IMS數據庫)。截至目前,公司在左乙拉西坦注射液項目上已投入研發費用約598萬元人民幣。

非布司他片主要用於痛風患者高尿酸血癥的長期治療。非布司他片由Tekeda研發,於2009年3月在美國上市。當前,美國境內,非布司他片的主要生產廠商有Viatris、Sun、Alembic等;國內生產廠商有江蘇恆瑞醫藥股份有限公司、成都倍特藥業股份有限公司等。2021年該藥品美國市場銷售額約3480.32萬美元(數據來源於IMS數據庫)。截至目前,公司在非布司他片項目上已投入研發費用約1430萬元人民幣。

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