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人福醫藥(600079.SH):宜昌人福氯化鉀緩釋片獲批上市
格隆匯 05-18 16:00

格隆匯5月18日丨人福醫藥(600079.SH)宣佈,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”)近日收到國家藥品監督管理局核准簽發的氯化鉀緩釋片的《藥品註冊證書》。

氯化鉀緩釋片是臨牀應用廣泛的電解質平衡調節劑,用於治療和預防伴或不伴代謝性鹼中毒的低鉀血癥。宜昌人福的氯化鉀緩釋片為中美共線產品,已於2018年獲得美國FDA批准的ANDA文號,此次在國內獲批視同通過一致性評價,其中0.75g規格為國內獨家規格。

根據米內網數據顯示2020年氯化鉀片劑(含緩釋片)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2億元,主要生產廠商包括上海海虹實業(集團)巢湖今辰藥業有限公司、深圳市中聯製藥有限公司、廣州譽東健康製藥有限公司等。

宜昌人福於2017年8月按照化學藥品新註冊分類的要求提交了氯化鉀緩釋片的註冊申請,截至目前該項目(含ANDA申報)累計研發投入約為1200萬元人民幣。

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