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迪哲醫藥(688192.SH):DZD1516獲批開展藥物臨牀試驗
格隆匯 07-07 16:11

格隆匯7月7日丨迪哲醫藥(688192.SH)公佈,公司近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的關於DZD1516的《藥物臨牀試驗批准通知書》。

DZD1516是公司自主研發的全球創新型具有完全穿透血腦屏障能力的高選擇性HER2抑制劑,現獲國家藥監局核准簽發的《藥物臨牀試驗批准通知書》,同意在人表皮生長因子受體2(HER2)陽性晚期乳腺癌中開展DZD1516聯合恩美曲妥珠單抗(T-DM1)II期臨牀研究。

HER2陽性乳腺癌發生中樞神經系統(CNS)轉移的比例高達40%–60%,而現有大部分化療或大分子靶向藥物不能有效通過血腦屏障。公司基於特有的腦轉移及腦膜轉移模型技術平台設計並開發DZD1516,截至2022年1月17日國際多中心I期臨牀研究結果顯示DZD1516在每日兩次低於300毫克的給藥劑量範圍內表現出良好的耐受性,基於其對野生型EGFR有高於300倍以上的選擇性,無患者發生腹瀉或皮疹的不良反應事件。患者體內,DZD1516的Kpuu, CSF(腦脊液與血漿中游離藥物濃度的比值)約為2.13,表明DZD1516能夠完全穿透血腦屏障。DZD1516研究成果先後在2021年聖安東尼奧乳腺癌大會(SABCS2021)和2022年度美國臨牀腫瘤學會(ASCO)大會做報吿。

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