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愛美客(300896.SZ):子公司重組人透明質酸酶注射液獲批開展臨牀試驗
格隆匯 12-06 18:53

格隆匯12月6日丨愛美客(300896.SZ)公佈,公司全資子公司北京諾博特生物科技有限公司近日收到國家藥品監督管理局核准簽發關於重組人透明質酸酶注射液的《藥物臨牀試驗批准通知書》,將於近期開展臨牀試驗。

透明質酸酶廣泛應用於醫療美容、眼科手術、藥物遞送、輔助生殖等領域,具有分解透明質酸、輔助藥物擴散、防止術後組織粘連等作用。生化提取的動物源性透明質酸酶最早於1948年在美國上市,目前國內外上市產品包括Vitrase®、Amphadase®、注射用玻璃酸酶等。重組人透明質酸酶相較於生化提取產品,具有原料來源不受限、安全性更高等特點,在國內相關應用領域存在較大的臨牀需求。全球唯一的重組人透明質酸酶Hylenex?於2005年在美國獲批上市,目前國內尚無重組人透明質酸酶注射液獲批上市。

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