人福醫藥(600079.SH):宜昌人福注射用苯磺酸瑞馬唑侖新增50mg規格獲批
格隆匯7月12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(簡稱“宜昌人福”,公司持有其80%的股權)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的《藥品補充申請批准通知書》。注射用苯磺酸瑞馬唑侖獲同意在原批准規格基礎上增加50mg規格,核發藥品批准文號。
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”。2022年3月獲批新增適應症為“全身麻醉誘導與維持”。2021年宜昌人福注射用苯磺酸瑞馬唑侖的市場銷售額約為人民幣6000萬元。公司的全資子公司武漢人福創新藥物研發中心有限公司於2022年1月收購PAION公司持有的中國大陸和香港地區的苯磺酸瑞馬唑侖的專利所有權。
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