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九典制藥(300705.SZ):厄貝沙坦片獲得藥品註冊證書
格隆匯 12-07 20:47

格隆匯 12 月 7日丨九典制藥(300705.SZ)公佈,公司於近日收到國家藥品監督管理局下發的藥品註冊證書,藥品通用名稱為厄貝沙坦片。

厄貝沙坦片用於治療原發性高血壓。合併高血壓的2型糖尿病腎病的治療。

厄貝沙坦片為血管緊張素II受體抑制劑,最初是由賽諾菲公司研製,商品名安博維(Aprovel),適用於原發性高血壓。該藥物1997年在英國首次上市,至今已經在全球50多個國家獲得廣泛應用;同年,厄貝沙坦與氫氯噻嗪的複方片由FDA批准在美國上市,並於1999年在歐盟獲准上市,厄貝沙坦也是歐盟批准的第一個用於預防糖尿病早期及晚期腎臟疾病的抗高血壓藥。

目前市場上主要抗高血壓藥物有鈣離子通道阻滯劑(CCB)、血管緊張素轉換酶抑制劑以及血管緊張素II受體抑制劑等抗高血壓藥物。血管緊張素II受體抑制劑通過拮抗血管緊張素II與AT1受體結合、鬆弛血管平滑肌、對抗醛固酮分泌、減少鈉瀦留、阻止成纖維細胞的增殖和皮內細胞凋亡,從而達到平穩有效降壓、逆轉心肌肥厚、減輕心力衰竭以及預防心房顫動電重構、改善高血壓患者胰島素抵抗、促進尿酸排泄。主要臨牀作用包括降壓作用、減輕左心室心肌肥厚、腎保護作用、腦血管保護作用等。

截至目前,國內共有13家(含公司)企業取得了厄貝沙坦片的藥品註冊批件,其中有6家通過一致性評價,公司該品種是按照新註冊分類4申報,視同通過一致性評價。

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