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人福醫藥(600079.SH):普瑞巴林緩釋片獲批臨牀試驗
格隆匯 03-16 17:25

格隆匯3月16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普瑞巴林緩釋片《藥物臨牀試驗批准通知書》。此次獲批臨牀的適應症為用於治療糖尿病周圍神經病變所伴有的神經性疼痛(DPN)。

普瑞巴林是一種新型鈣離子通道調節劑,能有效阻斷電壓依賴性鈣通道,減少神經遞質的釋放。普瑞巴林緩釋片臨牀上主要用於治療糖尿病周圍神經病變(DPN)相關的神經病理性疼痛和帶狀皰疹後神經痛(PHN)。目前國內上市的普瑞巴林製劑為普瑞巴林膠囊,根據米內網數據顯示,2021年普瑞巴林膠囊在我國城市、縣級及鄉鎮三大終端公立醫院的銷售額約為4.8億元人民幣,主要生產廠商為Pfizer Manufacturing Deutschland GmbH、重慶賽維藥業有限公司等。截至目前,宜昌人福在該項目上的累計研發投入約為2500萬元人民幣。

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