人福醫藥(600079.SH):宜昌人福咪達唑侖口服溶液獲批上市
格隆匯5月10日丨人福醫藥(600079.SH)宣佈,公司控股子公司宜昌人福(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咪達唑侖口服溶液的《藥品註冊證書》。咪達唑侖口服溶液用於兒童診斷或治療性操作前以及操作過程中的鎮靜/抗焦慮/遺忘,也可用於兒童術前鎮靜/抗焦慮/遺忘。
目前咪達唑侖口服溶液未在國內上市,根據國家藥品監督管理局網站顯示,新疆特豐藥業股份有限公司正在開展該藥品的臨牀試驗;江蘇恩華藥業股份有限公司正在進行鹽酸咪達唑侖糖漿的生產審評。根據Clarivate analytics數據統計,2018年咪達唑侖口服溶液劑全球銷售額約為4480萬美元。
宜昌人福於2019年8月按照化學藥品新註冊分類的要求提交了咪達唑侖口服溶液的註冊申請,截至目前該項目累計研發投入約為1500萬元人民幣。
公司表示,該次咪達唑侖口服溶液獲批後,宜昌人福將根據市場需求情況,着手安排生產上市。該產品充實了公司麻醉類藥品的產品線,其上市銷售將對公司帶來積極的影響。
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