美国北卡罗利市和中国上海市 2019年8月1日/

(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）今日宣布已向美国食品药品监督管理局（“FDA”）递交其候选药物艾贝司他治疗复发或难治性滤泡性淋巴瘤（“r / r FL”）的快速通道认定申请。

FDA的快速通道旨在促进治疗严重疾病药物或未满足临床需求药物开发和加快候选药物审评。获得快速通道认定的候选药物享有与美国FDA更多会议交流的机会，以及获得加速或优先审评等。美国FDA将审核此项请求并在60天内做出决定。

来自Cancer.net的数据显示，滤泡性淋巴瘤是美国和欧洲第二常见的淋巴瘤。徐诺药业正在进行一项艾贝司他单药治疗滤泡性淋巴瘤的关键2期临床试验。此项试验设计为单臂试验，将在美国和欧洲招募至少接受过三线治疗的大约120名患者，以测定艾贝司他单药四线治疗的有效性。

美国FDA已经授予艾贝司他与培唑帕尼（pazopanib）联用一线或二线治疗肾细胞癌（“RCC”）快速通道资格；徐诺药业正在全球进行此项随机对照的关键3期临床试验。

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，艾贝司它、 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。
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angela.feng@xynomicpharma.com

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