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特一藥業(002728.SZ):抗結核藥吡嗪酰胺片通過一致性評價
格隆匯 10-08 16:06

格隆匯10月8日丨特一藥業(002728.SZ)公佈,公司於近日獲得國家藥品監督管理局核准簽發的“吡嗪酰胺片”的《藥品補充申請批准通知書》,經審查,上述藥品通過仿製藥質量和療效一致性評價。

吡嗪酰胺片為抗結核藥物,可與其他抗結核藥(如鏈黴素、異煙肼、利福平及乙胺丁醇)聯合用於結核病治療。吡嗪酰胺片為國家基本藥物、《國家基本醫療保險、工傷保險和生育保險目錄(2020版)》甲類藥品、世界衞生組織(WHO)推薦的一線抗結核藥、抗結核治療標準療法中的基礎藥物,根據2010年WHO結核病防治司出台的《結核病治療指南》第4版,新患者的標準治療方案是2HRZE/4HR(H:異煙肼;R:利福平;Z:吡嗪酰胺;E:乙胺丁醇)。

該次“吡嗪酰胺片”仿製藥質量和療效一致性評價的通過,是公司研發能力、生產及質量管理體系等綜合實力的體現,也是國家藥品監管部門對上述綜合能力和產品質量的認可;同時,也為公司後續品種通過仿製藥質量和療效一致性評價提供了重要的經驗借鑑。該次“吡嗪酰胺片”通過仿製藥質量和療效一致性評價,對公司有積極影響,有利於公司參與集採的投標,增加產品的銷售渠道,擴大產品的市場份額。

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