人福醫藥(600079.SH):氟比洛芬酯注射液獲得藥物臨牀試驗批准通知書
格隆匯3月11日丨人福醫藥(600079.SH)公佈,公司控股子公司宜昌人福近日收到國家藥品監督管理局核准簽發的氟比洛芬酯注射液的《藥物臨牀試驗批准通知書》,經審查,2021年12月30日受理的氟比洛芬酯注射液符合藥品註冊的有關要求,同意本品開展人體生物等效性研究和用於術後及癌症鎮痛的隨機對照驗證性臨牀試驗。
氟比洛芬酯注射液是一款術後及癌症鎮痛藥物。根據米內網數據顯示,2020年氟比洛芬酯注射液在我國城市、縣級及鄉鎮三大終端公立醫院的銷售額約為人民幣7億元,主要生產廠商包括北京泰德製藥股份有限公司、武漢大安製藥有限公司等。截至目前,宜昌人福藥業在該項目上的累計研發投入約人民幣2600萬元。
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