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Telix Manufacturing Solutions (TMS) Established in Yokohama, Japan

  • Written by: PR Newswire Asia - Daily Bulletin Au RSS
Telix Manufacturing Solutions (TMS) Established in Yokohama, Japan

MELBOURNE, Australia and KYOTO, Japan, June 4, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix", "the Company") today announces that it has established Telix Manufacturing Solutions (TMS) in Yokohama, Japan. Telix's first cyclotron facility in the Asia Pacific region represents a significant milestone in the Company's global manufacturing strategy.

TMS Yokohama will serve as a hub for commercial and clinical supply, and future research and development in the region. It expands Telix's global production network which includes in-house and partner facilities. Originally opened in 2018, the site comprises a cyclotron and multiple production hot cells and was designed and built by JFE Engineering Corporation (JFE) as the Contract Manufacturing Organization (CMO) for TLX250-CDx (Zircaix®[1], 89Zr-girentuximab) in Japan and China, including for the ZIRCON-CP study[2].

Taking over the lease and operational management of this facility will provide greater control over existing clinical supply with the possibility to expand production to other Telix investigational and future commercial products in the region, including Illuccix® (TLX591-CDx, 68Ga-PSMA-11) and Pixclara®1 (TLX101-CDx, 18F-floretyrosine) for Greater Tokyo, and TLX591 (177Lu rosopatamab tetraxetan) for the Asia Pacific region. Further, the Company plans to install Telix's ARTMS QUANTM Irradiation System® (QIS®) cyclotron technology, which it believes will facilitate standardized, high-efficiency and cost-effective production of commercially important medical isotopes.

Darren Patti, Group Chief Operating Officer, Telix said, "We are pleased to announce Telix's first cyclotron facility in the Asia Pacific region, strategically located in Japan — the world's second-largest nuclear medicine market. TMS Yokohama enhances our capacity to meet growing demand in the region and supports our mission to provide patients with access to advanced diagnostic and therapeutic radiopharmaceuticals."

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).

Telix's prostate imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the United States Food and Drug Administration (FDA)[1], by the Australian Therapeutic Goods Administration (TGA)[2], by Health Canada[3], by the Brazilian Health Regulatory Agency (ANVISA)[4], by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)[5], by the French National Agency for the Safety of Medicine and Health Products (ANSM)[6] and in multiple countries within the European Economic Area (EEA)[7] following a positive decentralized procedure (DCP) opinion by the German medical regulator, BfArM[8]. TLX250-CDx, TLX101-CDx and TLX591 have not received a marketing authorization in any jurisdiction.

Visit 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 LinkedInX and Facebook.

Telix Investor Relations

Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com

[1] Telix ASX disclosure 20 December 2021.

[2] Telix ASX disclosure 2 November 2021.

[3] Telix ASX disclosure 14 October 2022.

[4] Telix ASX disclosure 18 March 2025.

[5] Telix ASX disclosure 13 February 2025.

[6] Telix media release 29 April 2025.

[7] Czech Republic, Denmark, Finland, Ireland, Luxembourg, Malta, the Netherlands, Norway and Sweden at time of release.

[8] Telix ASX disclosure 17 January 2025.

Legal Notices

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.

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.  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. 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.

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. 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. 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 commercialization of Telix's product candidates, if or when they have been approved; Telix's ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix's business; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

©2025 Telix Pharmaceuticals Limited. Telix Pharmaceuticals®, Telix 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.

Authors: PR Newswire Asia - Daily Bulletin Au RSS

Read more https://www.prnasia.com/story/archive/4701954_AE01954_0

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