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康哲藥業(00867.HK)Neurelis鼻腔噴霧產品獲美國FDA批准上市
阿思達克 01-14 04:53

康哲藥業(00867.HK)公布,Neurelis的急性治療藥物產品VALTOCO(地西泮鼻腔噴霧劑)已獲得美國食品藥品監督管理局(FDA)上市批准。此外,公司已於近期獲得國家藥品監督管理局對地西泮鼻噴霧劑的臨床試驗通知書,要求集團開展針對中國人群的比較藥代動力學研究,並在本品申請註冊上市的同時提交上市後進一步驗證本品療效及安全性的臨床研究計劃。

Neurelis是一家私人控股的專業製藥公司,旨在為癲癇和更廣泛的中樞神經系統(CNS)市場提供許可、開發和商業化候選產品。

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