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華東醫藥(000963.SZ):中美華東申報的瑞美吡嗪注射液的上市許可申請獲得受理
格隆匯 01-11 18:31

格隆匯1月11日丨華東醫藥(000963.SZ)公佈,2024年1月10日,華東醫藥股份有限公司全資子公司杭州中美華東製藥有限公司(簡稱“中美華東”)收到國家藥品監督管理局(NMPA)簽發的《受理通知書》(受理號:CXHS2400001),由中美華東申報的瑞美吡嗪注射液(英文名稱:Relmapirazin Injection;研發代碼:MB-102)的上市許可申請獲得受理。

瑞美吡嗪注射液最初由美國MediBeacon, Inc. (以下簡稱“MediBeacon 公司”)開發,作為熒光示蹤劑與同步研發的腎小球濾過率動態監測系統(簡稱“動態監測系統”)配合使用,以測量腎功能受損或正常患者的腎小球濾過率。

截至目前,公司在瑞美吡嗪注射液和動態監測系統項目合計研發直接投入約為23,763萬元。

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