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魯抗醫藥(600789.SH):達格列淨片獲得藥品註冊證書
格隆匯 11-04 17:49

格隆匯11月4日丨魯抗醫藥(600789.SH)公佈,近日,公司收到國家藥品監督管理局頒發的關於達格列淨片(“該藥品”)的《藥品註冊證書》(證書編號:2021S01093、2021S01094)。

該藥品為SGLT-2抑制劑(鈉-葡萄糖共轉運蛋白2)類新型口服降糖藥,用於2型糖尿病的治療。可作為單藥治療或聯合治療,在飲食和運動基礎上改善血糖控制。還可用於心力衰竭成人患者,用於射血分數降低的心力衰竭(HFrEF)成人患者(NYHAII-IV級),降低心血管死亡和因心力衰竭住院的風險。該品不適用於治療I型糖尿病或糖尿病酮症酸中毒。

根據米內網數據顯示,達格列淨是百時美施貴寶開發(已轉讓給阿斯利康)的一款新型口服降糖藥物,最早於2012年11月獲得歐洲EMA批准上市,是全球首款獲批上市的鈉-葡萄糖轉運蛋白2(SGLT2)抑制劑。2020年阿斯利康的達格列淨全球銷售額接近20億美元。原研產品於2017年3月獲批進入國內市場,2019年通過談判納入國家醫保乙類目錄,2021年上半年在中國公立醫療機構的銷售額接近10億元。公司為國內首個該藥品仿製藥申報和獲批企業。

截至公吿披露日,公司在該藥品的研發投入約為2160.66萬元人民幣(未經審計)。

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