恆瑞醫藥(600276.SH):注射用甲苯磺酸瑞馬唑侖獲藥品註冊批件
格隆匯1月2日丨恆瑞醫藥(600276.SH)公佈,公司近日收到國家藥品監督管理局(“藥監局”)核准簽發的《藥品註冊批件》。
藥品名稱:注射用甲苯磺酸瑞馬唑侖;劑型:注射劑;規格:36mg[按瑞馬唑侖(C21H19BrN4O2)計];註冊分類:化學藥品1類;受理號:CXHS1800002國;批件號:2019S00728;藥品批准文號:國藥準字H20190034;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,本品符合藥品註冊的有關要求,批准註冊,發給藥品批准文號。
注射用甲苯磺酸瑞馬唑侖是一種短效的GABAa受體激動劑,此次獲批的適應症為常規胃鏡檢查的鎮靜。公司經過大量的前期篩選和研究工作,開發了瑞馬唑侖的甲苯磺酸鹽。經查詢,國內外尚無同類產品上市銷售。PaionAG公司開發瑞馬唑侖的苯磺酸鹽,2018年12月在日本授權萌蒂製藥提交上市申請,2019年4月在美國提交新藥申請,2019年6月美國FDA已受理該申請。宜昌人福(PaionAG公司授權)於2018年11月15日向國家藥品監督管理局提交上市申請,目前狀態為“在審評審批中”。
截至目前,公司在該研發項目上已投入研發費用約7,135萬元人民幣。
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