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新華製藥(000756.SZ):恩格列淨片(10mg)取得藥品註冊證書
格隆匯 01-21 16:59

格隆匯1月21日丨新華製藥(000756.SZ)公佈,近日,山東新華製藥股份有限公司收到國家藥品監督管理局核准簽發的恩格列淨片(10mg)(以下簡稱“本品”)《藥品註冊證書》,本品符合藥品註冊的有關要求,批准註冊。

恩格列淨是由勃林格殷格翰公司和禮來公司共同開發的一種鈉-葡萄糖協同轉運蛋白-2(SGLT-2)抑制劑,通過減少腎臟的葡萄糖重吸收,降低腎糖閾,促進葡萄糖從尿液中直接排出,其還可減少鈉重吸收,增加鈉向遠端小管的轉運

恩格列淨片適用於治療2型糖尿病;用於症狀性慢性心力衰竭成人患者,降低因心力衰竭住院的風險。恩格列淨片是《國家基本醫療保險、工傷保險和生育保險藥品目錄》(2024年版)乙類品種。根據有關統計數據顯示,2023年恩格列淨片中國公立醫療機構終端銷售額約為人民幣6.1億元。

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