人福醫藥(600079.SH):注射用苯磺酸瑞馬唑侖增加適應症獲得藥品註冊證書
格隆匯3月16日丨人福醫藥(600079.SH)公佈,公司控股子公司宜昌人福近日收到國家藥品監督管理局核准簽發的關於注射用苯磺酸瑞馬唑侖增加適應症的《藥品註冊證書》。經審查,本品符合藥品註冊的有關要求,批准增加適應症,增加的適應症為“全身麻醉誘導與維持”,發給藥品註冊證書。
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,具有水溶性和消除半衰期短的特點。宜昌人福於2018年11月首次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,並於2020年7月獲批上市,獲批適應症為“用於結腸鏡檢查的鎮靜”。本次宜昌人福獲批的新適應症為“全身麻醉誘導與維持”。
截至目前宜昌人福對該項目的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,並於2021年3月獲得批准上市。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,並於2021年1月獲得批准上市。
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