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諾泰生物(688076.SH):依折麥布阿託伐他汀鈣片獲得藥品註冊證書
格隆匯 02-09 15:57

格隆匯2月9日丨諾泰生物(688076.SH)公佈,公司於近日收到國家藥品監督管理局核准簽發的依折麥布阿託伐他汀鈣片(I)、依折麥布阿託伐他汀鈣片(II)的《藥品註冊證書》(證書編號:2025S00317、2025S00316)。

依折麥布阿託伐他汀鈣片是依折麥布與阿託伐他汀的固定複方製劑,是可選擇性抑制膽固醇及相關植物甾醇的腸道吸收並抑制膽固醇內源性合成的降脂產品,用於治療高膽固醇血癥和純合子型家族性高膽固醇血癥(HoFH)。依折麥布作用於小腸刷狀緣,可抑制膽固醇吸收,導致小腸膽固醇至肝臟的遞送減少,阿託伐他汀可降低肝臟內膽固醇合成,兩者不同的作用機制可產生互補的降膽固醇作用。依折麥布阿託伐他汀鈣片相對於單方的使用,具有強效降脂,血脂達標率更高,方便快捷,用藥依從性更好等優勢。

依折麥布阿託伐他汀鈣片是公司獲批的又一款心血管領域製劑產品,為國內首仿上市,標誌着公司具備在國內市場銷售該產品的資格,彰顯了公司在產品迭代升級方面的核心競爭力,對公司未來發展具有積極意義。

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