美国北卡罗利市和中国上海市 2019年7月30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）今日宣布中国国家药品监督管理局药品审评中心（CDE）已正式批准徐诺药业在中国启动2项潜在关键性的临床试验。徐诺药业将在这两项临床试验中分别测试其领先候选药物艾贝司他（单药）三线治疗弥漫大B细胞淋巴瘤（DLBCL）和三线治疗滤泡性淋巴瘤（FL）。

根据中国国家癌症中心和中国国家卫生委员会的统计数据，弥漫大B细胞淋巴瘤是最常见的侵袭性非霍奇金淋巴瘤（NHL），中国每年估计有50,000例新发病例。滤泡性淋巴瘤是最常见的惰性NHL亚型，中国每年估计有10,000例新发病例。弥漫大B细胞淋巴瘤和滤泡性淋巴瘤合计大约占中国NHL市场的45-60%。

根据国家药品监督管理局药品审评中心数据库显示，徐诺药业的艾贝司他是目前唯一一项处于临床开发阶段的用于治疗弥漫大B细胞淋巴瘤的三线候选药物。徐诺药业预计将在12个月或更完成这两项潜在的关键性试验的患者招募。每项试验将在中国多达24家领先的血液癌症医院进行。

“我们对获得中国CDE的临床批准感到无比兴奋，中国已经成长为世界第二大肿瘤药市场。目前在中国，弥漫大B细胞淋巴瘤患者和滤泡性淋巴瘤患者在经R-CHOP治疗进展之后基本上没有其他获批的治疗选项。我们的艾贝司他在先前1/2期临床试验中显示了优异的安全性和有效性。我们期待尽快完成这项试验，并着手准备产品的商业化布局，”徐诺药业董事长兼首席执行官徐英霖先生评论说。

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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