微芯生物(688321.SH):西達本胺聯合替雷利珠單抗治療非小細胞肺癌II期臨牀試驗申請獲得受理
格隆匯11月9日丨微芯生物(688321.SH)公佈,公司近日收到國家藥品監督管理局簽發的IND(新藥臨牀試驗申請)《受理通知書》。
產品名稱:西達本胺片;適應症:西達本胺聯合PD-1抑制劑替雷利珠單抗一線治療PD-L1表達陽性的局部晚期或轉移性非小細胞肺癌(NSCLC)患者;臨牀階段:II期臨牀試驗。
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,是全球首個亞型選擇性組蛋白去乙酰化酶(HDAC)抑制劑,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疾病。目前已有兩個適應症成功獲批上市,用於治療外周T細胞淋巴瘤和乳腺癌。
非小細胞肺癌是除小細胞肺癌外所有肺癌組織分型的總稱,包括鱗狀細胞癌、腺癌和大細胞癌,非小細胞肺癌約佔總體肺癌患者的85%。西達本胺聯合免疫治療已經在非小細胞肺癌患者中顯示出初步但比較明確的聯合用藥療效,進一步證實了西達本胺的獨特作用機制對非小細胞肺癌有效。
替雷利珠單抗(BGB-A317)是一款由百濟神州的免疫腫瘤生物平台研發的候選藥物,是一種在研的人源性單克隆抗體,它屬於一類被稱為免疫檢查點抑制劑的腫瘤免疫藥物,能與細胞表面受體PD-1結合。目前替雷利珠單抗正作為單藥療法及聯合療法開發針對一系列實體瘤和血液腫瘤治療適應症。
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