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恆瑞醫藥(600276.SH):纖維支氣管鏡診療鎮靜劑注射用甲苯磺酸瑞馬唑侖獲批臨牀試驗
格隆匯 05-14 15:41

格隆匯5月14日丨恆瑞醫藥(600276.SH)公佈,公司及子公司上海恆瑞醫藥有限公司近日收到國家藥監局核准簽發的注射用甲苯磺酸瑞馬唑侖《臨牀試驗通知書》。

注射用甲苯磺酸瑞馬唑侖是一種短效的GABAA受體激動劑,本次獲批的適應症為纖維支氣管鏡診療鎮靜。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,該產品累計已投入研發費用約為7149萬元人民幣。

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