華領醫藥第二代GKA在美國啟動一期臨牀試驗並完成首例受試者入組
華領醫藥(2552.HK)宣佈第二代葡萄糖激酶激活劑(第二代GKA)的一期臨牀試驗已於美國正式啟動,並已於美國當地時間4月25日完成第一例受試者入組。該試驗是在40位美國2型糖尿病(T2D)患者中進行的隨機、雙盲、安慰劑對照、單次給藥劑量遞增藥代動力學和藥效學研究。第二代GKA是一種具有優化的理化性質的新分子實體,採用華領醫藥專有的製劑技術,設計為每日一次口服給藥。第二代GKA片劑旨在通過緩釋技術延長藥物在體內的作用時間、改善患者依從性以及延長刺激腸道內GLP-1分泌的效果,更好地實現24小時內血糖控制;同時,第二代GKA片劑具備與現有獲批治療藥物聯用的潛力,實現24小時內有效控制血糖,特別是針對血糖水平波動較大的患者,在其與GLP-1治療聯用時,有望產生巨大的協同效應,為患者帶來多重獲益。由華領醫藥自主研發的第一代GKA藥物多格列艾汀,於2022年9月獲中國國家藥品監督管理局批准上市,並於2023年12月被國家醫療保障局納入《國家基本醫療保險、工傷保險和生育保險藥品目錄》。華領醫藥保留第二代GKA的全球專利權,一期臨牀試驗順利完成後,公司計劃尋求合作伙伴,推進第二代GKA在全球市場的開發。
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