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人福醫藥(600079.SH):宜昌人福氯巴佔片申報生產獲受理
格隆匯 04-11 16:02

格隆匯4月11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氯巴佔片申報生產的《受理通知書》。

氯巴佔片可用於治療兒童難治性癲癇發作,屬於罕見病用藥,適用於2歲及以上Lennox-Gastaut綜合徵(LGS)患者癲癇發作的聯合治療,國內暫無該活性成分批准上市銷售。根據IQVIA數據統計,氯巴佔口服制劑2020年在全球銷售額約為3億美元。截至目前,宜昌人福該項目累計投入約為4500萬元人民幣。

公司表示,氯巴佔片申報生產被國家藥品監督管理局受理,標誌着該品種境內生產藥品註冊工作進入了審評階段,公司將積極推進後續相關工作,如順利通過審評審批,將豐富公司的產品線,有利於提升公司的市場競爭力。

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