微芯生物(688321.SH):西達本胺臨牀試驗申請獲得受理
格隆匯11月27日丨微芯生物(688321.SH)公佈,近日收到國家藥品監督管理局藥物審評中心簽發的境內生產藥品註冊臨牀試驗的《受理通知書》,西達本胺臨牀試驗申請獲得國家藥監局藥審中心受理。西達本胺(Chidamide;商品名為“愛譜沙/Epidaza”),國家1類原創新藥,是公司獨家發現的新分子實體藥物,機制新穎。作為領域唯一可口服的亞型選擇性組蛋白去乙酰化酶(HDAC)抑制劑,西達本胺對腫瘤抑制性免疫微環境具有重新激活作用,可單獨或聯合其他藥物解決嚴重威脅人類健康的惡性腫瘤等重大疾病,具有廣闊的潛在應用前景。
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