哈藥股份(600664.SH):鹽酸二甲雙胍片通過仿製藥一致性評價
格隆匯10月31日丨哈藥股份(600664.SH)公佈,近日,公司分公司哈藥集團製藥六廠(以下簡稱“哈藥六廠”)收到國家藥品監督管理局頒發的關於鹽酸二甲雙胍片的《藥品補充申請批件》(批件號:2019B04039),該藥品通過仿製藥質量和療效一致性評價。
鹽酸二甲雙胍片具有控制2型糖尿病患者血糖的作用,該類藥品最先於1959年在法國上市。鹽酸二甲雙胍片可減少肝糖生成,抑制葡萄糖的腸道吸收,並增加外周組織對葡萄糖的攝取和利用,可通過增加外周糖的攝取和利用而提高胰島素的敏感性。截至本公告日,哈藥六廠針對該藥品一致性評價已投入研發費用約人民幣670萬元(未經審計),2018年該藥品未上市銷售。
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