微芯生物(688321.SH):西達本胺片的臨牀試驗申請獲受理
格隆匯 4 月 19日丨微芯生物(688321.SH)公佈,公司今日收到國家藥品監督管理局(“國家藥監局”)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:西達本胺聯合恩沃利單抗治療經PD-1抑制劑治療耐藥的非小細胞肺癌(NSCLC)患者;臨牀階段:開放、多中心II期臨牀研究;結論:根據《中華人民共和國行政許可法》第三十二條的規定,經審查,決定予以受理。
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,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%。根據2018年在癌症免疫治療協會年會(SITC)公開披露的Ib/II期臨牀試驗結果,晚期非小細胞肺癌患者入組13例,其中完成評價8例,客觀緩解率為38%,疾病控制率75%。西達本胺聯合免疫治療在此類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。
恩沃利單抗(Envafolimab)(研發代碼:KN035)是由康林傑瑞和思路迪聯合開發,中國自主研發的全球首個皮下注射的人源化PD-L1單域抗體。KN035有6 項臨牀研究正在進行。其中3項I期臨牀試驗為KN035單藥治療,分別在中國、美國和日本進行。I期的初步結果顯示Envafolimab和其他PD-1/PD-L1 抗體藥物有類似的療效和安全性,而相對於其他腫瘤免疫類藥物的靜脈注射方式,Envafolima皮下注射使用更加方便;其他的臨牀研究,包括dMMR/MSI-H晚期結直腸癌及其他晚期實體瘤適應症和晚期胃癌或胃食管結合部腺癌適應症的探索性臨牀試驗,以及對於不能手術切除或轉移性的初治膽道癌適應症的III期臨牀研究。其中,針對dMMR/MSI-H晚期結直腸癌及其他晚期實體瘤的II期臨牀試驗已完成,在中國提交的NDA(新藥申請)上市申請已於2020年12月17日獲受理。
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