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人福醫藥(600079.SH):宜昌人福鹽酸右美託咪定鼻噴霧劑獲批臨牀試驗
格隆匯 02-22 17:01

格隆匯2月22日丨人福醫藥(600079.SH)公佈,公司控股子公司宜昌人福藥業有限責任公司(簡稱“宜昌人福”,公司持有其80%的股權)近日收到國家藥品監督管理局核准簽發的鹽酸右美託咪定鼻噴霧劑的《藥物臨牀試驗批准通知書》。

鹽酸右美託咪定鼻噴霧劑是宜昌人福開發的一款術前鎮靜藥物。目前國內尚無同類型產品上市,已上市產品為鹽酸右美託咪定注射液,用於行全身麻醉的手術患者氣管插管和機械通氣時的鎮靜。根據米內網數據顯示,2020年鹽酸右美託咪定注射液在我國城市、縣級及鄉鎮三大終端公立醫院的銷售額約為人民幣40億元,主要生產廠商包括揚子江藥業集團有限公司、江蘇恆瑞醫藥股份有限公司等。截至目前,宜昌人福藥業在該項目上的累計研發投入約500萬元人民幣。

根據我國藥品註冊相關的法律法規要求,宜昌人福在收到上述藥物臨牀試驗通知書後,將着手啟動藥物的臨牀研究相關工作,待完成臨牀研究後,將向國家藥品監督管理局遞交臨牀試驗數據及相關資料,申報生產上市。

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