微芯生物(688321.SH):CS231295臨牀試驗申請獲得FDA受理
格隆匯7月1日丨微芯生物(688321.SH)公佈,公司的全資子公司微芯生物科技(美國)有限公司於6月30日收到美國食品藥品監督管理局(以下簡稱“FDA”)的書面回覆,公司自主研發的CS231295關於晚期實體瘤的臨牀試驗申請獲得FDA受理。
CS231295作為透腦AuroraB選擇性抑制劑,一方面通過精準抑制腫瘤特異性過表達的AuroraB激酶,誘導合成致死效應,直擊RB1缺失等難治性腫瘤的基因脆弱性;另一方面,憑藉良好的血腦屏障穿透能力,對腦部原發或腦轉移性腫瘤存在明顯的治療優勢。同時,該分子還兼具改善腫瘤微環境的廣譜抗腫瘤活性,有望為存在類似遺傳缺陷的不同類型腫瘤,以及腫瘤腦轉移這一全球難題提供全新解題思路。目前,全球尚無同類設計的藥物進入臨牀試驗階段。
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