恆瑞醫藥(600276.SH):注射用甲苯磺酸瑞馬唑侖、注射用HRS3797獲批臨牀試驗
格隆匯7月18日丨恆瑞醫藥(600276.SH)公佈,公司子公司福建盛迪醫藥有限公司近日收到國家藥品監督管理局(“國家藥監局”)核准簽發關於注射用甲苯磺酸瑞馬唑侖、注射用HRS3797的《藥物臨牀試驗批准通知書》,將於近期開展臨牀試驗。
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5月8日受理的注射用甲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。
根據《中華人民共和國藥品管理法》及有關規定,經審查,2021年5月10日受理的注射用HRS3797符合藥品註冊的有關要求,同意本品開展用於全身麻醉誘導期氣管插管及維持術中骨骼肌鬆弛的臨牀試驗。
注射用甲苯磺酸瑞馬唑侖是一種短效的GABA受體激動劑,公司已獲批的適應症為常規胃鏡檢查鎮靜和結腸鏡檢查鎮靜。本次獲批開展臨牀的適應症為重症監護(ICU)期間鎮靜,國內外尚無同適應症同類產品上市銷售。Paion AG公司開發的瑞馬唑侖的苯磺酸鹽,2020年1月在日本獲批上市用於全身麻醉,2020年7月在美國獲批上市用於程序鎮靜的誘導與維持,2020年7月在中國獲批上市用於結腸鏡檢查的鎮靜。截至目前,注射用甲苯磺酸瑞馬唑侖相關項目累計已投入研發費用約為9762萬元。
注射用HRS3797是一種超短效非去極化肌松藥,擬用於全身麻醉誘導期氣管插管及維持術中骨骼肌鬆弛。目前,國內外尚未有同類產品獲批上市,亦無相關銷售數據。截至目前,注射用HRS3797相關項目累計已投入研發費用約為1,078萬元。
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