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澤璟製藥(688266.SH):ZG19018片治療KRASG12C突變的晚期惡性實體瘤的臨牀試驗獲得批准
格隆匯 12-28 16:25

格隆匯12月28日丨澤璟製藥(688266.SH)公佈,公司於近日收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》,ZG19018片治療KRASG12C突變的晚期惡性實體瘤的臨牀試驗獲得批准。

ZG19018是由公司自主研發的KRASG12C選擇性共價抑制劑,屬於1類小分子抗腫瘤新藥,具有全球知識產權。目前全球範圍內僅有一款同類機制藥物獲批上市。臨牀前研究結果顯示ZG19018具有顯著的抑制KRASG12C突變腫瘤生長和細胞增殖的藥效作用,具有藥物半衰期長和口服生物利用度高等藥代動力學特徵,且在腫瘤和腦組織中具有高藥物濃度。ZG19018有望成為一個治療KRASG12C突變腫瘤的創新藥。

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