7月2日消息 - 环球医学据悉，国家食品和药物管理局（SFDA）已批准voclosporin进行多中心的全球III期临床试验。

致力于研究、开发、制造和销售生物制药产品的中国领先的生物技术公司¬¬—三生制药，已获得国家食品药品监督管理局（SFDA）的批准，进行voclosporin的多中心III期临床试验，并且作为新一代钙神经素抑制剂得到来自日本Isotechnika制药的许可。

根据经批准的协议，这将是一项在肾移植患者中进行的III期、随机、多中心、浓度对照的比较研究。预计将在2012年第三季度开始招募试验患者。（环球医学）

原文：

3SBio to join global ph III trial for Voclosporin

It has received the state Food and Drug Administration's approval to conduct the China arm of the multi-center phase III trial of voclosporin

Singapore: 3SBio, a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, has received State Food and Drug Administration (SFDA) approval to conduct the China arm of the multi-center phase III trial of voclosporin, a new generation calcineurin inhibitor licensed from Japan's Isotechnika Pharma.

According to the approved protocol, this will be a phase III, randomized, multi-center, concentration-controlled comparison study on renal transplant patients. Patient enrollment is expected to begin in the third quarter of 2012.

相关链接：http://www.biospectrumasia.com/biospectrum/regulatory/2125/3sbio-join-global-ph-iii-trial-voclosporin

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