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美諾華(603538.SH):磷酸西格列汀原料藥通過CDE技術審評
格隆匯 09-28 16:58

格隆匯9月28日丨美諾華(603538.SH)公佈,近日,公司控股子公司浙江美諾華磷酸西格列汀原料藥通過國家藥品監督管理局藥品審評中心(以下簡稱“CDE”)技術審評,在CDE原料藥、藥用輔料和藥包材登記信息公示平台上顯示登記號轉為“A”狀態,且收到國家藥品監督管理局下發的《化學原料藥上市申請批准通知書》。

藥品適應症:用於改善2型糖尿病患者的血糖控制。藥理作用與作用機制:磷酸西格列汀是一種口服的高度選擇性DPP-4類小分子抑制劑,DPP-4抑制劑可以通過抑制腸促胰素GLP-1的失活,起到促進胰島素分泌,並抑制胰高血糖素的分泌的作用,是2型糖尿病一種新的治療藥物。

磷酸西格列汀片劑由默克公司原研開發,商品名:Januvia®,2006年首次在美國上市。

浙江美諾華於2021年4月13日向CDE提交了磷酸西格列汀的審評申請,2022年9月27日,磷酸西格列汀通過審評審批,登記狀態標識為“A”。本次對該產品累計研發投入共計439.8萬元(未經審計)。

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