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尖峯集團(600668.SH):富馬酸伏諾拉生獲得化學原料藥上市申請批準通知書

格隆匯8月13日丨尖峯集團(600668.SH)公佈,下屬子公司安徽尖峯北卡藥業有限公司(簡稱“尖峯北卡”)收到國家藥品監督管理局關於化學原料藥富馬酸伏諾拉生的《化學原料藥上市申請批準通知書》。富馬酸伏諾拉生(VonoprazanFumarate)是由日本武田藥品工業株式會社研發的用於治療反流性食管炎的鉀離子競爭性酸阻滯劑。本品進入人體後,在胃壁細胞泌酸的最後步驟,通過抑制K+與H+-K+-ATP酶(質子泵)的結合,終止胃酸的分泌,達到抑酸效果,本品具有強勁、持久的抑制胃酸分泌作用。與傳統PPI相比,本品無需酸的活化,且有效性更優。富馬酸伏諾拉生在CDE原輔包登記信息平臺顯示狀態爲“A”的企業共二十九家,爲四川科倫藥業股份有限公司、齊魯製藥有限公司等。

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