徐诺药业|针对晚期以及转移性肾细胞癌全球关键3期临床试验完成首例中国患者入组和聘请医学监查员
09/26/2019 新闻 admin

上海 9月13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)其候选药物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潜在关键性3期临床试验完成首例中国患者入组。此项试验正在包括北京肿瘤医药在内的全国17 肿瘤医药进行,北京肿瘤医院的副所长,肾癌&黑色素瘤内科主任郭军教授是此临床试验的主要研究者。

根据美国国际贸易管理局的数据,中国是世界第二大医药市场。预计到2020年将从1080亿美元增长到1670亿美元,年增长率为9.1%。2015年公共和私人医疗保健支出总额达到6400亿美元,预计到2020年将达到1.1万亿美元。

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当中。目前,该试验正在美国,欧洲和韩国进行中。艾贝司他与培唑帕尼联用一线或二线治疗RCC已经获得FDA的快速审批通道认定。

“根据中国临床肿瘤学会的数据显示,中国每年约有46,900例肾癌患者。大多数患者对培唑帕尼或其他现有的标准治疗方法产生耐药性。艾贝司他与培唑帕尼联合使用可能会逆转耐药性并显着延长患者的无进展生存期。我们很高兴能够在中国启动这项正在进行的全球临床试验,非常期待与郭军博士和其他领先的中国肾癌专家合作。“徐诺药业董事长兼首席执行官徐英霖先生评论道。

此外,徐诺药业聘请了Kapilan Rajagopalan博士担任医学监查员。在加入徐诺药业之前, Rajagopalan博士曾在Tata Consultancy Services公司担任药物安全性经理和药物安全性医生,负责管理罗氏和拜耳的多个新药项目(2016-2019年)。2014年至2015年Rajagopalan博士作为MD / MBA实习医生在Humana实习。2012年至2013年,Rajagopalan博士在St. Joseph Mercy Hospital担任家庭医学住院医生。我们相信Rajagopalan博士的医学知识及其在肿瘤药物医学评估方面的经验,将有效加强徐诺药业的临床监查能力。Rajagopalan博士拥有辛辛那提大学生物学学士学位(Summa Cum Laude荣誉毕业生)、路易斯维尔大学MBA学位和辛辛那提大学医学博士学位。

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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