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恆瑞醫藥(600276.SH):HR20005凝膠的藥物臨牀試驗獲批
格隆匯 02-08 20:41

格隆匯 2 月 8日丨恆瑞醫藥(600276.SH)公佈,公司子公司山東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HR20005凝膠的《藥物臨牀試驗批准通知書》,將於近期開展臨牀試驗。

根據《中華人民共和國藥品管理法》及有關規定,經審查,2020123日受理的HR20005凝膠符合藥品註冊的有關要求,同意本品開展用於緩解成人靜脈穿刺痛的臨牀試驗。

2020123日,公司向國家藥監局提交的HR20005凝膠臨牀試驗申請獲得受理,擬用於緩解靜脈留置針穿刺時的疼痛

本品能夠通過透皮作用進入用藥部位末梢神經周圍,阻斷神經細胞膜上鈉離子通道,抑制鈉離子流入神經纖維細胞膜內,阻斷神經興奮與傳導產生可逆性的局部阻滯,從而達到鎮痛和麻醉的效果。目前針對靜脈留置針穿刺鎮痛,國內外有貼劑、乳膏劑和無針粉末經皮注射給藥製劑等多種劑型獲批上市,如1992年於美國獲批上市的EMLA1994年於日本獲批上市的Penles經查詢,2019PenlesEMLA相關劑型的產品全球銷售額分別約643美元7,415元。截至目前,HR20005凝膠項目累計已投入研發費用約為714萬元

根據我國藥品註冊相關的法律法規要求,藥物在獲得藥物臨牀試驗批准通知書後,尚需開展臨牀試驗並經國家藥監局審評、審批通過後方可生產上市。

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