人福醫藥(600079.SH)：注射用苯磺酸瑞馬唑侖獲批開展用於重症監護(ICU)期間鎮靜的II期和III期臨牀試驗
格隆匯9月17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80%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《藥物臨牀試驗批准通知書》。
審批結論：根據《中華人民共和國藥品管理法》及有關規定，經審查，2021年7月14日受理的注射用苯磺酸瑞馬唑侖符合藥品註冊的有關要求，同意本品開展用於重症監護(ICU)期間鎮靜的II期和III期臨牀試驗。
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，本次獲批臨牀試驗的適應症為重症監護(ICU)期間的鎮靜。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，並於2020年7月獲批上市，獲批適應症為結腸鏡檢查鎮靜。截至目前對該項目(含本次)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。
根據我國藥品註冊相關的法律法規要求，宜昌人福在收到上述藥物臨牀試驗通知書後，將着手啟動藥物的臨牀研究相關工作，待完成臨牀研究後，將向國家藥品監督管理局遞交臨牀試驗數據及相關資料，申報生產上市。
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