貝達藥業(300558.SZ):參股公司禾元生物新藥奧福民獲批上市
格隆匯7月18日丨貝達藥業(300558.SZ)公佈,今日,國家藥品監督管理局官方網站公示,國家藥監局批準貝達藥業股份有限公司參股公司武漢禾元生物科技股份有限公司(簡稱“禾元生物”)申報的重組人白蛋白注射液(水稻)(商品名:奧福民®,OsrHSA,HY1001,簡稱“奧福民®”)上市,獲批的適應症爲“適用於肝硬化低白蛋白血癥(≤30g/L)的治療”。
奧福民®是利用水稻胚乳細胞表達,經提取、純化的重組人血清白蛋白產品。其II期、III期臨牀試驗均採用與血漿來源人血清白蛋白(pHSA)頭對頭對比研究,兩項臨牀試驗均達到了主要和次要臨牀研究終點,展示了奧福民®良好的療效和安全性。
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