信立泰(002294.SZ):恩那度司他片(恩那羅)獲得藥品註冊證書
格隆匯6月9日丨信立泰(002294.SZ)公佈,近日,深圳信立泰藥業股份有限公司收到國家藥品監督管理局核准簽發的“恩那度司他片”(恩那羅®)藥品註冊證書。
恩那度司他片(恩那羅®)適應症為非透析的成人慢性腎臟病(CKD)患者的貧血治療(以下簡稱為腎性貧血),是國內上市的新一代缺氧誘導因子脯氨酰羥化酶抑制劑(HIF-PHI)藥物。
作為新一代HIF-PHI藥物,恩那羅®對HIF靶點的調控更加合理適度,刺激生成的內源性EPO(促紅細胞生成素)更貼近生理濃度,平穩可控升高血紅蛋白,整體安全性良好。此外還具有一天一次口服給藥、用藥依從性好,無需按體重調整,藥物相互作用風險低等優勢。上市後,將為廣大腎性貧血患者帶來全新的用藥選擇,更好地滿足該領域未被滿足的臨牀需求。
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