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信立泰(002294.SZ):恩那司他片上市申請獲受理
格隆匯 01-03 16:30

格隆匯1月3日丨信立泰(002294.SZ)公佈,近日,公司提交的恩那司他片申報上市申請獲得國家藥品監督管理局受理。

恩那司他片是一種抗腎性貧血口服小分子創新制劑,已開發的適應證為腎性貧血。相較現有療法,恩那司他片改善貧血機制明確,既可促進內源性促紅細胞生成素的生成,也可改善鐵的利用;且具有良好的安全性和有效性,可顯著提高患者依從性。

公司於2019年12月從日本JAPAN TOBACCO INC.引進國內,若能獲批上市,預計將是國內第二個上市的HIF-PHI藥物。上市後將為患者提供更高效、安全的新治療選擇。

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