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億帆醫藥(002019.SZ):子公司收到鹽酸多巴胺注射液境內註冊上市許可申請受理通知書
格隆匯 01-12 19:26

格隆匯1月12日丨億帆醫藥(002019.SZ)公佈,公司全資子公司合肥億帆生物製藥有限公司於2022年1月11日收到國家藥品監督管理局簽發的鹽酸多巴胺注射液境內註冊上市許可申請《受理通知書》。

鹽酸多巴胺注射液適用於急性循環功能不全(心源性休克、失血性休克),主要有:(1)無尿、少尿或利尿劑無效時;(2)增加脈率;(3)使用其他強心劑/升壓劑不耐受或無效時,用於臨牀急救例如休克、心力衰竭、急性腎損傷的救治和圍手術期血壓維持。

鹽酸多巴胺注射液最早由HOSPIRAINC開發,於1974年2月由FDA批准上市。公司於2021年5月完成鹽酸多巴胺注射液藥學研究工作,於2021年12月向藥監局遞交上市申請,並於2022年1月11日獲得受理。

根據米內網數據顯示,2020年鹽酸多巴胺注射液國內市場銷售額約4.4億元。截止報吿披露日,公司在該項目上研發投入294萬元。

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