海普瑞(002399.SZ):參股公司新藥III期臨試數據獲FDA突破性療法認定
格隆匯2月4日丨海普瑞(002399.SZ)公佈,公司的參股公司Resverlogix Corp.於2020年2月3日發佈了在研創新藥品種RVX-208(Apabetalone)研發進展,具體如下:
1、RVX-208聯合包括高強度他汀類藥物在內的標準療法用於近期出現急性冠狀動脈綜合徵的2型糖尿病患者主要不良心臟事件的二級預防,獲得了美國食品藥品監督管理局(以下簡稱美國FDA)突破性療法認定。
2、獲得突破性療法認定能夠顯著地支持RVX-208的商業化開發計劃。Resverlogix Corp.將與美國FDA密切協作,促成藥品開發計劃有效率地實施。
3、美國FDA授予的突破性療法認定,是一種藥品加速開發和審評的程序,適用於治療嚴重疾病且初步臨牀證據顯示出顯著優於現有療法的藥品。
公司表示,參股公司新藥RVX-208根據已完成的III期臨牀試驗數據獲得美國FDA的突破性療法認定,有利於其商業開發計劃更加快速有效的實施,有利於公司創新藥業務的發展和佈局。
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