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Full-Life Technologies Achieves Regulatory Milestone With Nuclear Permit, Advancing Radioisotope Facility Construction

Full-Life Technologies Achieves Regulatory Milestone With Nuclear Permit, Advancing Radioisotope Facility Construction

FullLife Technologies通过核许可实现监管里程碑,推进放射性同位素设施建设
PR Newswire ·  03/25 20:00

GEMBLOUX, Belgium, March 25, 2024 /PRNewswire/ -- Full-Life Technologies ("Full-Life"), today announced the recent achievement of its subsidiary "Full-Life Technology Europe" has obtained a Nuclear Permit for a class IIA facility from the Belgium Federal Agency for Nuclear Control ("FANC"), authorizing the construction and operation of this pivotal facility for producing therapeutic radioisotopes.

比利时GEMBLOUX,2024年3月25日 /PRNewswire/ — Full-Life Technologies(“Full-Life Technology Europe”)最近取得的成就已获得比利时联邦核控制局(“FANC”)的IIA类设施的核许可,授权建造和运营该生产治疗性放射性同位素的关键设施。

"The Nuclear Permit is a significant regulatory milestone towards the construction of our radioisotope facility, which is an integral part of Full-Life's strategy to build a fully-integrated radiopharmaceutical company," said Philippe van Put, General Manager of Full-Life Technology Europe. "Actinium-225 ("Ac-225") has emerged as a highly promising, alpha-emitter isotope for use in radiotherapeutics to treat cancer, but demand has outstripped supply. The facility, when completed, will provide this radioisotope to support pre-clinical and clinical studies of our internal pipeline candidates but also for the commercialization of Ac-225 radiolabelled compounds to contribute towards addressing the urgent global demand for Ac-225 radiopharmaceuticals."

全寿科技欧洲总经理菲利普·范普特表示:“核许可证是我们建设放射性同位素设施的重要监管里程碑,这是Full-Life建立一家完全整合的放射性制药公司的战略不可分割的一部分。”“Actinium-225(“Ac-225”)已成为一种非常有前途的α-发射体同位素,用于放射治疗癌症,但需求已超过供应。该设施建成后,将提供这种放射性同位素,以支持我们内部候选药物的临床前和临床研究,还将用于Ac-225放射性标记化合物的商业化,为满足全球对Ac-225放射性药物的迫切需求做出贡献。”

The permit, for a class IIA facility, reflects result of a comprehensive and effective collaboration among diverse stakeholders, including authorities and control organism. Central to this collaborative effort has been the preparation and submission of a detailed safety report to FANC on the future facility. This report is a critical component of the authorization process, as it must demonstrate that all nuclear safety aspects, including installation, processes, and organizational structure, have been meticulously evaluated and meet stringent safety and regulatory standards.

该IIA类设施的许可证反映了包括主管部门和控制机构在内的不同利益相关者之间全面有效合作的结果。这项合作工作的核心是编写并向FANC提交有关未来设施的详细安全报告。该报告是授权程序的关键组成部分,因为它必须证明包括装置、流程和组织结构在内的所有核安全方面都经过了仔细的评估,符合严格的安全和监管标准。

"Obtaining this Nuclear Permit affirms our adherence to the highest nuclear safety standards for our upcoming facility," said Mr. van Put. "Our comprehensive safety measures, forward-thinking production approaches, and reliable logistics systems underscore our dedication to elevating patient care and radiotherapeutic research." The 4,000 square meter, state-of-the-art facility, which will sit on 17,000 square meters of land, will serve as Full-Life's production hub.

范普特说:“获得这份核许可证实了我们对即将建成的设施的最高核安全标准的坚持。”“我们全面的安全措施、前瞻性的生产方法和可靠的物流系统凸显了我们对提升患者护理和放射治疗研究的承诺。”这座占地4,000平方米、最先进的设施将占地17,000平方米,将作为Full-Life的生产中心。

About Full-Life Technologies

关于全寿命科技

Full-Life Technologies Limited ("Full-Life") is a fully integrated global radiotherapeutics company with operations in Belgium, Germany, and China. We seek to own the entire value chain for radiopharmaceutical research & development, production & commercialization in order to deliver clinical impact for patients. The Company plans to attack core issues affecting radiopharmaceuticals today through innovative research that targets the treatments of tomorrow. We are comprised of a team of fast-moving entrepreneurs and scientists with a demonstrated track record in the life sciences, as well as radioisotope research and clinical development.

FullLife Technologies Limited(“Full-Life”)是一家完全整合的全球放射治疗公司,业务遍及比利时、德国和中国。我们力求拥有放射性药物研发、生产和商业化的整个价值链,以便为患者带来临床影响。该公司计划通过针对未来治疗的创新研究,解决当今影响放射性药物的核心问题。我们由一支快速发展的企业家和科学家组成的团队组成,他们在生命科学以及放射性同位素研究和临床开发方面有着良好的往绩。

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来源 Full-Life 技术

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