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艾力斯(688578.SH):注射用AST2169脂質體獲得藥物臨牀試驗批准通知書
格隆匯 03-13 19:15

格隆匯3月13日丨艾力斯(688578.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》,自主研發的注射用AST2169脂質體(稱“AST2169”)在KRAS G12D突變晚期實體瘤患者中安全性、耐受性、藥代動力學及初步療效的 I 期臨牀研究獲得藥物臨牀試驗批准。

AST2169是公司自主研發的具有全球知識產權的KRAS G12D選擇性抑制劑。KRAS G12D突變是KRAS 突變的一種常見的亞型,存在於非小細胞肺癌、結直腸癌、胰腺癌等多種類型癌症中。雖然KRAS突變在人類癌症中的作用已經為人所知幾十年,但針對KRAS 突變的抗癌療法研發進展緩慢。目前全球範圍內尚無KRAS G12D 抑制劑獲批上市。

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