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上海萊士(002252.SZ):“SR604注射液”臨牀試驗申請獲得受理
格隆匯 12-21 16:36

格隆匯12月21日丨上海萊士(002252.SZ)公佈,公司2023年12月21日收到國家藥品監督管理局下發的關於“SR604注射液”臨牀試驗申請《受理通知書》(受理號:CXSL2300875)。

SR604注射液是一種人源化高親和力結合人活化蛋白C,特異性抑制人活化蛋白C抗凝血功能的單克隆抗體製劑。擬用於血友病A/B及先天性凝血因子Ⅶ缺乏症患者出血的預防治療。目前國內外血友病常規預防治療是每週2-3次靜脈注射血源或重組凝血因子。SR604擬開展每4週一次的皮下注射預防治療臨牀I期試驗。該項目的部分臨牀前研究成果已在國際血液學研究期刊Blood雜誌上以封面文章的形式發表。截至公吿披露日,全球尚無與該藥物同靶點的產品上市。

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