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国内外周T细胞淋巴瘤原创药获批第二个适应症,这次是乳腺癌

2019-11-22 佚名 医谷

日前,微芯生物西达本胺新适应症获批,用于联合内分泌疗法治疗ER+、HER2-、经既往内分泌治疗复发/转移的晚期乳腺癌患者,该适应症于2018年11月申报上市,2019年1月被纳入优先审评审批。

日前,微芯生物西达本胺新适应症获批,用于联合内分泌疗法治疗ER+、HER2-、经既往内分泌治疗复发/转移的晚期乳腺癌患者,该适应症于2018年11月申报上市,2019年1月被纳入优先审评审批。


作为微芯生物目前的独家上市产品且是主要收入来源,西达本胺为苯酰胺类组蛋白去乙酰化酶(Histone Deacetylase,HDAC)亚型选择性抑制剂,主要针对第I类HDAC中的1、2、3亚型和第IIb类的10亚型, 具有对肿瘤异常表观遗传功能的调控作用。西达本胺通过抑制相关HDAC亚型以增加染色质组蛋白的乙酰化水平来引发染色质重塑,并由此产生针对多条 信号传递通路基因表达的改变(即表观遗传改变),进而抑制肿瘤细胞周期、诱导肿瘤细胞凋亡,同时对机体细胞免疫具有整体调节活性,诱导和增强自然杀伤细胞(NK)和抗原特异性细胞毒T细胞(CTL)介导的肿瘤杀伤作用。


西达本胺一般作用机理 图片来源:微芯生物招股书

2014年12月,西达本胺在国内获得新药证书和注册批件,用于治疗外周T细胞淋巴瘤(PTCL),这是我国首个以二期临床试验结果获批上市的国家1类原创新药,也是目前国内唯一治疗外周T细胞淋巴瘤的药物,2015年3月,西达本胺正式上市销售,2017年8月,西达本胺作为医保谈判药品进入国家医保目录,零售价格统一调整为385元/片(5mg/片),治疗费用降为1.85万元/月,在医保支付比例较高的地方,患者自付月治疗费用仅为几千元,远低于国外同种药品的治疗费用。2016年度、2017年度、2018年度,西达本胺产品销售收入和其境外专利授权许可收入的合计分别为8529万元、1.1亿元、1.46亿元,占微芯生物同期营业收入比例分别为99.92%、99.81%、99.2%。

据悉,今年5月,一项发表在《柳叶刀》杂志上关于西达本胺联合依西美坦治疗晚期HR+乳腺癌的Ⅲ期临床结果显示,在至少一次内分泌治疗后出现疾病复发或进展患者中,经研究者评估西达本胺与依西美坦联合用药无进展生存期较安慰剂联合依西美坦组显着改善(7.4个月VS 3.8个月),其中在有内脏转移的患者中差异更明显。在独立审查委员会的评估中,西达本胺组更具优势,中位PFS达9.2个月,疾病进展风险降低29%。


西达本胺与其他激素阳性乳腺癌二线治疗方法对比 图片来源:微芯生物招股书

另悉,西达本胺用于治疗非小细胞肺癌NSCLC)的临床试验已进入三期,目前尚无HDAC抑制剂获批该适应症,其有望与其他药物联用用于治疗NSCLC,同时,西达本胺还在单药及联合其他抗肿瘤药物在多个国家和地区开展针对弥漫性大B细胞淋巴瘤、非小细胞肺癌及HIV的临床研究。

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