九洲藥業(603456.SH):達格列淨收到化學原料藥上市申請批準通知書
格隆匯7月28日丨九洲藥業(603456.SH)公佈,收到國家藥品監督管理局頒發的關於達格列淨的《化學原料藥上市申請批準通知書》,達格列淨片主要用於治療2型糖尿病成人患者。公司於2024年2月向國家藥品監督管理局藥品審評中心(以下簡稱“CDE”)提交該原料藥的上市申請,並於近日取得國家藥監局下發的《化學原料藥上市申請批準通知書》。該原料藥在CDE原輔包登記信息平臺上顯示狀態爲“A”。截至目前,公司已在達格列淨累計研發投入約爲人民幣505萬元。
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