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特一藥業(002728.SZ):鹽酸二甲雙胍緩釋片通過一致性評價
格隆匯 04-22 18:32

格隆匯4月22日丨特一藥業(002728.SZ)公佈,公司全資子公司海南海力製藥有限公司(“海力製藥”)於近日獲得國家藥品監督管理局核准簽發的“鹽酸二甲雙胍緩釋片”《藥品補充申請批准通知書》,經審查,上述藥品通過化學仿製藥質量和療效一致性評價。

鹽酸二甲雙胍適用於作為飲食和運動的輔助治療,以改善成人和兒童 II 型糖尿病患者的血糖控制。二甲雙胍也可與磺酰脲類藥物或胰島素同時使用,以改善成人的血糖控制。二甲雙胍是糖尿病患者的首選治療藥物,具有降糖、改善胰島素抵抗等作用。國內外上市主要劑型為片劑,而緩釋片可明顯降低服藥後胃腸道的不良反應,並減少每日服藥次數,由每日服藥 2-3 次降低為每日 1 次,進而提高了藥物安全性和順應性。

次“鹽酸二甲雙胍緩釋片”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實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寶貴經驗借鑑。此次“鹽酸二甲雙胍緩釋片”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,提升產品的市場競爭力,擴大產品的市場份額。

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