徐诺药业| 艾贝司他单药治疗4线滤泡性淋巴瘤获FDA快速通道认定
09/26/2019 新闻 admin

中国上海, Sept. 23, 2019 (GLOBE NEWSWIRE) -致力于抗肿瘤新药开发的中美跨国制药公司徐诺药业（股票代码：XYNO）今日宣布其候选药物艾贝司他单药治疗4线滤泡性淋巴瘤获得FDA快速通道认定。快速通道认定是FDA为了促进和加快审评治疗严重或危及生命疾病的药物，以满足未竟医疗需求。

根据美国国家癌症研究所的数据显示，滤泡性淋巴瘤是美国最常见的惰性非霍奇金淋巴瘤亚型，每年约有14840例新发病例。滤泡性淋巴瘤通常需要多线治疗。尽管目前已有多种治疗方案，但三线治疗失败患者的选择仍然不多。三线治疗后患者的中位PFS和EFS都不到1年。徐诺药业正在进行艾贝司他单药四线治疗复发或难治性滤泡性淋巴瘤的关键性2期试验。此试验在美国和欧洲同步进行。

此外，艾贝司他与培唑帕尼联用一线或二线治疗局部晚期或转移性肾细胞癌（RCC）的全球性、随机对照的潜在关键3期临床试验正在进行中。艾贝司他与培唑帕尼联用一线或二线治疗RCC已经获得FDA的快速通道认定。

关于徐诺药业

徐诺药业是一家专注于肿瘤药物开发的生物制药公司。

徐诺药业目前的产品管线主要包括三款候选药物，艾贝司他、 XP-105 和 XP-102。公司拥有这些药物的全球独家开发、生产和商业化权益。其领先的候选药物艾贝司他正在进行治疗肾细胞癌（与培唑帕尼联用）和单药治疗非霍奇金淋巴瘤的全球关键临床试验。徐诺药业另外一款临床阶段候选药物为可进入临床2期的XP-105（BI 860585），这是一个ATP竞争性的mTORC1 / 2抑制剂，对多种实体瘤有效。徐诺药业的临床前候选药物XP-102（BI 882370）是一个泛-RAF抑制剂。

投资者关系、媒体和商务拓展请联系：

angela.feng@xynomicpharma.com

Use of Forward-Looking Statements

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