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TAE生命科学公司的中子束系统获得验收,使BNCT在中国开始临床试验

TAE Life Sciences’ Neutron Beam System Receives Acceptance Enabling the Start of BNCT Clinical Trials in China

PHARMA FOCUS ASIA | 2024-04-04 | 翻译由动脉网AI生成,点击反馈

可切换为仅中文


TAE Life Sciences, a pioneer in advancing Boron Neutron Capture Therapy (BNCT) for cancer treatment, proudly announces the successful completion of acceptance testing and regulatory registration inspection of its accelerator- based neutron beam system (NBS), marking a significant milestone in BNCT global market adoption.

TAE Life Sciences是推动硼中子俘获疗法(BNCT)用于癌症治疗的先驱,它自豪地宣布其基于加速器的中子束系统(NBS)的验收测试和监管注册检查成功完成,标志着BNCT全球市场采用的一个重要里程碑。

Developed and manufactured in the United States, TAE Life Sciences’ NBS has met all specifications outlined by Neuboron Medical and the local regulatory body, enabling human BNCT clinical trials to begin this month in China.The completion of acceptance testing underscores TAE Life Sciences’ commitment to international safety and efficacy standards, making it the first US company to have its system achieve such recognition.

TAE Life Sciences的NBS是在美国开发和制造的,符合Neubrobon Medical和当地监管机构概述的所有规格,使人体BNCT临床试验能够于本月在中国开始。验收测试的完成突显了TAE Life Sciences对国际安全性和有效性标准的承诺,使其成为第一家系统获得此类认可的美国公司。

This major technological progress demonstrates how TAE Life Sciences has solidified its leading position in the growing field of BNCT. As the company progresses in establishing Alphabeam BNCT sites worldwide, collaborating with Neuboron to provide them with a Neutron Beam System has paved a distinctive pathway into the Chinese market.“We worked closely with Neuboron to ensure our accelerator-based NBS precisely delivered the results required for BNCT and are thrilled to have successfully completed acceptance testing and regulatory inspection,” stated Rob Hill, CEO at TAE Life Sciences.

这一重大技术进步证明了TAE生命科学如何巩固其在BNCT不断增长的领域中的领先地位。随着公司在全球范围内建立Alphabeam BNCT站点的进展,与Neubroban合作为其提供中子束系统,为其进入中国市场铺平了独特的道路。TAE Life Sciences首席执行官Rob Hill表示:“我们与Neubroban密切合作,以确保我们基于加速器的国家统计局准确地交付了BNCT所需的结果,并且很高兴成功地完成了验收测试和监管检查。”。

“This milestone not only demonstrates our dedication to delivering cutting-edge cancer treatment solutions, but also signifies our ability to meet rigorous international standards.”Additionally, the Beijing Institute of Medical Device Testing has completed registration testing of the full Neuboron Medical’s NeuPex AB-BNCT system, which includes TAE Life Science’s NBS.

“这一里程碑不仅表明了我们致力于提供尖端的癌症治疗解决方案,也标志着我们有能力达到严格的国际标准。”此外,北京医疗器械检测研究所已经完成了完整的Neubroban Medical NeuPex AB-BNCT系统的注册测试,其中包括TAE Life Science的NBS。

This milestone marks a significant regulatory approval step, enabling Neuboron to move.

这一里程碑标志着一个重要的监管批准步骤,使Neubrobon能够移动。

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