Telix制造解决方案比利时交付首批GMP级商业剂量-动脉网

Telix Manufacturing Solutions Belgium Delivers First GMP-Grade Commercial Doses

CISION 等信源发布 2025-06-25 16:04

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可切换为仅中文

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MELBOURNE

墨尔本

, Australia and

，澳大利亚和

INDIANAPOLIS

印第安纳波利斯

，

June 25, 2025

2025年6月25日

/PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ:

/PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, 纳斯达克:

TLX

, 'Telix', 'the Company') today announces that its Telix Manufacturing Solutions (TMS) facility in Brussels South (Seneffe),

，'Telix'，'公司'）今天宣布其位于布鲁塞尔南部（塞内夫）的Telix制造解决方案（TMS）设施，

Belgium

比利时

, has produced its first Good Manufacturing Practice (GMP)-grade commercial radiopharmaceutical doses and delivered them to the AIRC

，已经生产出其首个符合优良制造规范（GMP）的商业放射性药物剂量，并将其交付给AIRC。

[1]

hospital collaboration in Charleroi,

沙勒罗瓦医院合作，

Belgium

比利时

。

TMS Brussels South is one of

TMS布鲁塞尔南是其中之一

Europe's

欧洲的

largest radiopharmaceutical production facilities, with nine GMP lines, clean rooms, a radiopharmacy, and two cyclotrons across a 2,800 square metre footprint.

最大的放射性药物生产设施，拥有九条GMP生产线、洁净室、放射药房以及两台回旋加速器，占地面积达2800平方米。

Raphael Ortiz

拉斐尔·奥尔蒂斯

, Chief Executive Officer, Telix International, commented, 'We are excited to launch Telix's commercial radiopharmacy capability in

`, 首席执行官，Telix国际公司，评论道，'我们很高兴在`

Europe

欧洲

and demonstrate our ability to meet the needs of patients and partners. Through our bench-to-bedside capabilities we can now provide GMP-grade products and radiolabelling services to customers in

并展示我们满足患者和合作伙伴需求的能力。通过我们的从实验室到床边的能力，我们现在可以为客户提供GMP级产品和放射性标记服务。

Europe

欧洲

and beyond. This is a further point of differentiation for Telix.'

以及更远。这是Telix的另一个差异化点。

Dr. Ivan Duran Derijckere, AIRC, added, 'Following the accreditation of TMS Brussels South, many more regions in

伊万·杜兰·德里克博士，AIRC补充道：“继TMS布鲁塞尔南部门诊获得认证后，更多地区

Belgium

比利时

will now have access to GMP-grade radiopharmaceuticals. I would like to thank Telix for its leadership and continued investment in innovative products and services for patients with cancer, which will have a direct positive impact on outcomes including quality of life.'

现在将可以使用GMP级放射性药物。我要感谢Telix的领导地位，并持续投资于创新的产品和服务，为癌症患者带来直接的积极影响，包括生活质量的提升。

Prof. Dr. Nadia Withofs, President of the Belgian Society of Nuclear Medicine (BELNUC) continued, '

比利时核医学学会（BELNUC）主席纳迪亚·威瑟夫斯教授继续说道：

Belgium

比利时

and the Wallonia region have a rich history in nuclear medicine, and we are thrilled to see this continue with Telix's pioneering facility in Brussels South becoming GMP operational. TMS Brussels South can now manufacture GMP-grade 'hot doses' that are ready for patients today. And beyond this, the impressive research, development and manufacturing scale-up capabilities mean that it will also serve as a vital hub for future production of clinically and commercially important isotopes and radiopharmaceuticals.'.

瓦隆地区在核医学方面有着丰富的历史，我们很高兴看到随着Telix在布鲁塞尔南部的先锋设施实现GMP运营，这一传统得以延续。TMS布鲁塞尔南现在可以生产符合GMP标准的“热剂量”，为患者提供即时可用的药物。除此之外，其令人印象深刻的研发和制造规模扩展能力意味着它还将成为未来临床和商业重要同位素及放射性药物生产的重要枢纽。

For more information or to order finished radiopharmaceuticals, active pharmaceutical ingredients, or related services, licensed healthcare professionals in

欲了解更多信息或订购成品放射性药物、活性药物成分或相关服务，获得许可的医疗专业人员请

Europe

欧洲

can visit:

可以访问：

https://www.radiopharmastore.com/

About

关于

Telix Manufacturing Solutions (TMS)

特利克斯制造解决方案（TMS）

TMS is a global network of facilities for in-house production and distribution of radiopharmaceuticals, including through collaboration with strategic partners. Located in the heart of Belgium's 'Radiopharma Valley', TMS Brussels South is one of

TMS 是一个全球性的设施网络，用于放射性药物的内部生产和分销，包括通过与战略合作伙伴的合作。位于比利时“放射性药物谷”中心的 TMS 布鲁塞尔南是其中之一。

Europe's

欧洲的

largest radiopharmaceutical production facilities, with nine GMP lines, clean rooms, a radiopharmacy, and two cyclotrons across a 2,800 square metre footprint. TMS Brussels South also has extensive research and development (R&D) capabilities, with a focus on alpha-emitting isotopes.

最大的放射性药物生产设施，拥有九条GMP生产线、洁净室、放射性药房以及两台回旋加速器，占地面积达2800平方米。TMS布鲁塞尔南还拥有强大的研发能力，专注于发射α粒子的同位素。

About

关于

Telix Pharmaceuticals Limited

特利克斯制药有限公司

Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in

Telix是一家专注于治疗和诊断放射性药物及其相关医疗技术的开发和商业化的生物制药公司。Telix总部位于

Melbourne, Australia

墨尔本，澳大利亚

, with international operations in

，在国际业务方面

the United States

美国

，

Brazil

巴西

，

Canada

加拿大

，

Europe

欧洲

(

Belgium

比利时

and

和

Switzerland

瑞士

), and

），并且

Japan

日本

. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ:

Telix正在开发一系列临床和商业阶段的产品，旨在满足肿瘤学和罕见病领域未被满足的重大医疗需求。Telix在澳大利亚证券交易所（ASX: TLX）和纳斯达克全球精选市场（NASDAQ）上市。

TLX

）。

Visit

访问

www.telixpharma.com

for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on

欲了解有关Telix的更多信息，包括最新股价、ASX和SEC文件、投资者和分析师简报、新闻发布、活动详情及其他可能感兴趣的出版物，您还可以关注Telix。

领英

，

and

和

Facebook

。

Telix Investor Relations

特力投资者关系

Ms. Kyahn Williamson

威廉森·凯恩女士

Telix Pharmaceuticals Limited

特力制药有限公司

SVP Investor Relations and Corporate Communications

投资者关系和企业传播高级副总裁

Email:

电子邮件：

kyahn.williamson@telixpharma.com

Legal Notices

法律声明

You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website.

您应结合我们最近向澳大利亚证券交易所 (ASX)、美国证券交易委员会 (SEC) 提交的报告中披露的风险因素一并阅读本公告，包括我们向 SEC 提交的 20-F 表年度报告，或我们网站上的相关内容。

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification.

本公告所含信息并非意图在任何司法管辖区（包括美国）内，就Telix Pharmaceuticals Limited (Telix) 的证券提出认购要约、邀请或推荐。本公告所含信息和意见可能随时更改，恕不另行通知。

To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise.

在法律允许的最大范围内，Telix拒绝承担更新或更正本公告中包含的任何信息或意见的义务或承诺，包括任何前瞻性声明（如下所述），无论是否由于新信息、未来发展、预期或假设的变更或其他原因。

No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement..

本公告中包含或表达的信息或意见，不对其准确性或完整性作出任何明示或暗示的陈述或保证。

This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as 'may', 'expect', 'intend', 'plan', 'estimate', 'anticipate', 'believe', 'outlook', 'forecast' and 'guidance', or the negative of these words or other similar terms or expressions.

本公告可能包含前瞻性陈述，包括符合1995年美国私人证券诉讼改革法案含义的陈述，这些陈述涉及预期的未来事件、财务表现、计划、战略或业务发展。前瞻性陈述通常可以通过使用诸如“可能”、“预期”、“意图”、“计划”、“估计”、“预测”、“相信”、“展望”、“预报”和“指导”等词语或这些词语的否定形式或其他类似术语或表达来识别。

Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements.

前瞻性声明涉及已知和未知的风险、不确定性以及其他可能导致我们的实际结果、活动水平、表现或成就与这些前瞻性声明中明示或暗示的任何未来结果、活动水平、表现或成就存在重大差异的因素。

Forward-looking statements are based on Telix's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical trials, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix's product candidates, manufacturing activities and product marketing activities; Telix's sales, marketing and distribution and manufacturing capabilities and strategies; the commercial.

前瞻性声明基于Telix对公司财务、市场、监管及其他风险和考量因素的善意假设，这些因素目前存在并将影响Telix未来的业务和运营，但无法保证任何假设会被证明是正确的。在Telix的业务背景下，前瞻性声明可能包括但不限于以下方面的陈述：Telix的临床前和临床试验的启动、时间、进展和结果，以及Telix的研发计划；Telix将其候选产品推进至临床研究、招募并成功完成临床试验（包括多国临床试验）的能力；Telix候选产品的监管申报和批准的时间或可能性、生产活动及产品营销活动；Telix的销售、市场营销与分销及生产能力与策略；商业化相关事宜。

Telix

特利克斯

Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country.

[1]

L'Association Interhospitalière de la Région de Charleroi, an inter-hospital collaboration between three hospitals: Grand Hopital de Charleroi (GHdC), Clinique Notre-Dame de Grâce de Gosselies (CNDG) and HUmani.

查勒罗伊地区医院间协会，是三家医院之间的跨医院合作组织：查勒罗伊大医院（GHdC）、戈塞利的格雷斯圣母诊所（CNDG）和HUmani。

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