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易明醫藥(002826.SZ):全資子公司米格列醇片通過一致性評價
格隆匯 04-21 15:36

格隆匯4月21日丨易明醫藥(002826.SZ)公佈,公司全資子公司四川維奧製藥有限公司(“維奧製藥”)於近日獲得國家藥品監督管理局核准簽發的化學藥品“米格列醇片(50mg)”的《藥品補充申請批件》,通過該品種仿製藥質量和療效一致性評價(“一致性評價”)。維奧製藥作為米格列醇片質量標準的起草單位,此次全國首批通過該品種的一致性評價。

米格列醇片適應症為配合飲食控制和運動,用於改善成人2型糖尿病患者血糖控制,在糖尿病患者中,通過抑制α-葡萄糖苷酶可延遲葡萄糖的吸收,降低餐後高血糖,削平血糖峯值水平。同時米格列醇對乳糖酶的抑制作用較小,在推薦劑量下,米格列醇不會導致乳糖不耐症;對肝臟損害的患者,因米格列醇不經肝臟代謝,藥代動力學對肝臟功能沒有影響。

米格列醇(口服常釋劑型)已列入《國家醫保目錄(2019年版)》,是醫保乙類藥品。米格列醇等α-糖苷酶抑制劑為《中國2型糖尿病防治指南(2017年版)》推薦一線治療藥物(A類推薦),指南推薦單藥使用或二聯治療(與二甲雙胍聯用)。

根據國家相關政策規定,對於通過一致性評價的藥品品種,在醫保支付方面予以適當支持;醫療機構應優先採購併在臨牀中優先選用;同時,通過一致性評價的產品將具備參加國家藥品集中採購的資格。

該品種於2019年列入《國家醫保目錄(2019年版)》,此次通過一致性評價,有利於擴大產品的市場銷售,提高市場競爭力,對公司的經營業績產生積極影響,併為公司進行中的其他產品一致性評價工作積累寶貴的經驗。

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