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千金藥業(600479.SH):抗乙肝病毒感染類藥物獲一致性評價
格隆匯 11-28 16:50

格隆匯11月28日丨千金藥業(600479.SH)公佈,近日,公司下屬子公司湖南千金湘江藥業股份有限公司(以下簡稱“千金湘江藥業”)收到國家藥品監督管理局核准簽發拉米夫定片的《藥品補充申請批件》,該藥品通過仿製藥質量和療效一致性評價。

拉米夫定片為抗乙肝病毒感染類藥物,適用於伴有丙氨酸氨基轉移酶升高和病毒活動複製的肝功能代償的成年慢性乙型肝炎病人的治療。拉米夫定片為2019年版國家醫保目錄乙類品種。

千金湘江藥業選用美國上市的Glaxo Smith Kline的拉米夫定片(Epivir-HBV)為參比製劑進行了產品一致性評價研究。通過對參比製劑的處方進行剖析,採用反向工程和風險評估的方法,對影響產品質量的關鍵質量屬性和關鍵工藝參數進行研究,並通過對比自制產品與參比製劑在不同介質中的溶出曲線,保證產品質量穩定可控,且與參比製劑相當。綜上,千金湘江藥業開發的拉米夫定片達到了質量與療效與參比製劑一致。

目前國內共有27個拉米夫定片藥品生產批文。截至本公告日,用於治療慢性乙肝、規格為0.1g的拉米夫定片,僅有千金湘江藥業的產品通過了國家藥品監督管理局一致性評價審批。

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