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賽升藥業(300485.SZ):達格列淨片境內生產藥品註冊上市許可申請獲得受理
格隆匯 03-17 16:08

格隆匯3月17日丨賽升藥業(300485.SZ)公佈,公司子公司北京賽而生物藥業有限公司(簡稱“賽而生物”)近日收到了國家藥品監督管理局下發的達格列淨片境內生產藥品註冊上市許可申請的《受理通知書》。

達格列淨是新型口服降糖藥,最早由百時美施貴寶開發,後將知識產權以及全球生產銷售權利許可給阿斯利康。2012年達格列淨獲得歐洲EMA批準用於治療2型糖尿病,是SGLT-2類藥物中全球首個獲批的藥物;2014年獲得美國FDA批準上市,是FDA第二個批準的SGLT-2抑制劑。2017年達格列淨進入中國市場,是我國第一個批準上市的SGLT-2抑制劑,主要通過抑制腎小管從尿中重吸收葡萄糖,促進葡萄糖從尿液中排出,從而降低血糖,優點是不會引起低血糖、體重增加、嚴重的胃腸道反應等不良反應,甚至可以預防胰島β細胞功能的下降,另外口服給藥提高了患者順應性。

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