人福醫藥(600079.SH):鹽酸阿芬太尼注射液獲藥品註冊批件
格隆匯3月2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(以下簡稱“宜昌人福”,公司持有其67%的股權)近日收到國家藥品監督管理局核准簽發的鹽酸阿芬太尼注射液的《藥品註冊批件》。
鹽酸阿芬太尼注射液作為麻醉性鎮痛劑用於全身麻醉誘導和維持。目前鹽酸阿芬太尼注射液未在國內上市,根據國家藥品監督管理局網站顯示,國內江蘇恩華藥業股份有限公司正在進行該藥品的生產審評;根據IQVIA數據統計,2018年鹽酸阿芬太尼注射液全球銷售額約為1400萬美元。
宜昌人福於2017年10月按照化學藥品新註冊分類的要求提交了鹽酸阿芬太尼注射液的註冊申請,截至目前該項目累計研發投入約為2000萬元人民幣。本次鹽酸阿芬太尼注射液獲批後,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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