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億帆醫藥(002019.SZ):子公司鹽酸去氧腎上腺素注射液境內註冊上市許可申請獲受理
格隆匯 02-17 18:41

格隆匯2月17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2月16日收到國家藥品監督管理局簽發的鹽酸去氧腎上腺素注射液境內註冊上市許可申請《受理通知書》。

鹽酸去氧腎上腺素注射液適用於治療麻醉狀態下由血管擴張引起的低血壓。鹽酸去氧腎上腺素注射液最早由Avaedl Legacy開發,1954年首次在美國上市。公司於2022年1月向藥監局遞交上市申請,並於2022年2月16日獲得受理。

截止報吿披露日,去氧腎上腺素注射液僅上海禾豐製藥有限公司上市銷售,有廣東中潤醫藥有限公司/廣東星昊藥業有限公司(聯合申報)、成都苑東生物製藥股份有限公司和包括公司在內的3家企業按照一致性評價標準申報3類仿製,暫無企業通過或視同通過一致性評價。

根據米內網數據顯示,去氧腎上腺素注射液2020年國內銷售額為6835萬元,2021年上半年銷售額為4108萬元。截至2022年1月,公司在項目上累計研發投入206萬元。

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