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華東醫藥(000963.SZ):腎小球濾過率動態監測系統進入創新醫療器械特別審查程序
格隆匯 11-09 16:38

格隆匯11月9日丨華東醫藥(000963.SZ)公佈,公司全資子公司杭州中美華東製藥有限公司(中美華東)與持股4. 61%參股子公司美國MediBeacon Inc. (“MediBeacon公司)合作開發的腎小球濾過率動態監測系統於近日國家藥品監督管理局(NMPA)同意進入創新醫療器械特別審查程序,該產品將按創新醫療器械進行註冊審評審批。

MediBeacon®腎小球濾過率動態監測系統(以下簡稱TGFR)是全球首款可實現經皮、牀旁、實時、動態、連續測量腎功能正常和腎功能受損人羣腎小球濾過率(GFR)的監測系統。該系統配合專用光示蹤劑MB-102注射液(Relmapirazin),可以將熒光示蹤劑的清除率通過專利算法轉換為GFR並在主機上顯示,實現實時、動態、連續GFR監測,對早期急性腎功能損傷臨牀診療方案的指導腎功能不全的診斷具有突破性的臨牀意義。 該系統主要工作原理為全球首創,在美國共有32件已授權專利,其中,15件已公開,12進入中國美國食品藥品監督管理局(FDA)201810月授予該技術突破性醫療器械認定,給予加速審評審批。

與該系統配合使用的專用熒光示蹤劑, MB-102注射液(Relmapirazin )1類新藥,其國際多中心III期臨牀試驗申請已於20215月獲得國家藥品監督管理局(NMPA)批准(詳見公司於2021512日發佈的相關公吿)。

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