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步長製藥(603858.SH):他達拉非片獲得美國FDA批准文號
格隆匯 10-30 17:57

格隆匯10月30日丨步長製藥(603858.SH)宣佈,公司近日知悉,根據美國食品藥品監督管理局(“FDA”)批准函顯示,公司全資子公司楊凌步長製藥有限公司向FDA申報的他達拉非片獲得了簡略新藥申請(“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)的批准。他達拉非片適應症為“治療勃起功能障礙”。截至目前,該項目公司累計投入約為140萬美元。

PDE5抑制劑是國內外公認的ED一線治療方案,目前市場上銷售的主要產品有美國輝瑞公司的萬艾可(西地那非)和德國拜耳公司的艾力達(伐地那非),以及美國禮來公司的希愛力(他達拉非)。他達拉非是這三種ED治療藥物中起效最快,藥效持續時間最長,且唯一不受高脂飲食和酒精攝入影響的藥物。他達拉非2019年全球銷售額約11.98億美元。

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