石藥集團(01093.HK):羅沙司他膠囊獲藥品註冊批件
格隆匯7月5日丨石藥集團(01093.HK)發佈公吿,集團開發的羅沙司他膠囊(20mg/50mg)已獲得中國國家藥品監督管理局頒發的藥品註冊批件。該產品為中國首仿獲批,並視同通過仿製藥質量和療效一致性評價。
羅沙司他是全球第一個低氧誘導因子 – 脯氨醯羥化酶抑制劑(HIF-PHI),適用於正在接受透析及非透析治療的患者因慢性腎臟病(CKD)所引起的貧血。羅沙司他作為新一代機制全新的口服腎性貧血治療藥物,通過激活HIF通路,促進內源性促紅細胞生成素(EPO)生成,下調鐵調素水平,改善鐵的吸收、轉運和利用,糾正貧血。在《中國腎性貧血診治臨牀實踐指南》及《羅沙司他治療腎性貧血中國專家共識》中,羅沙司他獲最高級別(1A級)推薦。該產品的獲批將進一步豐富集團在血液和造血系統治療領域的產品線,併為患者提供新的選擇。
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