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中關村(000931.SZ)鹽酸羥考酮注射液化學藥品4類註冊申報收到國家藥監局《受理通知書》
格隆匯 08-16 17:32

格隆匯8月16日丨中關村(000931.SZ)公佈,近日,公司全資子公司北京中關村四環醫藥開發有限責任公司之控股子公司北京華素製藥股份有限公司(華素製藥)收到國家藥品監督管理局(國家藥監局)簽發的《受理通知書》,華素製藥研發的鹽酸羥考酮注射液按照化學藥品4類進行註冊申報。

藥品名稱為鹽酸羥考酮注射液;劑型為注射劑;製劑規格為1ml:10mg;2ml:20mg;註冊分類為化學藥品4類。

2019年07月26日,華素製藥向國家藥監局遞交了鹽酸羥考酮注射液化學藥品4類註冊申報。該品為強效鎮痛藥,用於治療中度至重度急性疼痛,包括手術後引起的中度至重度疼痛,以及需要使用強阿片類藥物治療的重度疼痛。

鹽酸羥考酮注射液由萌蒂製藥研發,最早於2004年在荷蘭上市,同年在瑞典上市;2012在日本上市,2013年在中國上市銷售。2018年國內銷售額為3.8億元,且目前尚未有國內生產廠家獲批上市。

華素製藥研發的鹽酸羥考酮注射液按照化學藥品4類(仿製境內已上市原研藥品的藥品)進行註冊申報,並於2019年8月13日獲得國家藥監局簽發的《受理通知書》。

截止公告日,鹽酸羥考酮注射液項目已累計投入研發費用逾139萬元。

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