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人福醫藥(600079.SH):注射用苯磺酸瑞馬唑侖獲藥品註冊證書
格隆匯 07-20 16:01

格隆匯 7 月 20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(“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注射用苯磺酸瑞馬唑侖的《藥品註冊證書》。

藥品名稱:注射用苯磺酸瑞馬唑侖;劑型:注射劑;規格:25mg(按C21H19BrN4O2計);藥品批准文號有效期:至2025年07月15日。

注射用苯磺酸瑞馬唑侖是由宜昌人福聯合德國PAION公司共同開發的新型苯二氮䓬類藥物,為超短效GABAa受體激動劑,此次獲批的適應症為結腸鏡檢查的鎮靜。宜昌人福於2018年11月向國家藥品監督管理局提交注射用苯磺酸瑞馬唑侖上市申請,截至目前對該項目累計投入約為人民幣1億元。德國PAION公司於2019年11月向European Medicines Agency(歐洲藥品管理局)遞交苯磺酸瑞馬唑侖程序鎮靜適應症上市申請,目前正在審批中。經德國PAION公司授權,Mundipharma公司在日本遞交苯磺酸瑞馬唑侖全身麻醉適應症上市申請,並於2020年1月獲得批准上市;Cosmo公司在美國遞交苯磺酸瑞馬唑侖程序鎮靜適應症上市申請,並於2020年7月獲得批准上市;Hana Pharm公司於2019年12月在韓國遞交苯磺酸瑞馬唑侖全身麻醉適應症上市申請,目前正在審批中。

此次注射用苯磺酸瑞馬唑侖獲批後,宜昌人福將根據市場需求情況,着手安排生產上市。該產品充實了公司產品線,其上市銷售將對公司帶來積極的影響。該產品未來的具體銷售情況可能受到行業政策、市場環境等因素影響,具有不確定性,敬請廣大投資者謹慎決策,注意防範投資風險。

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