Illuccix China Phase 3 Study Completes Enrolment

Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix", "the Company") today announces that the pivotal Phase 3 registration study of TLX591-CDx (Illuccix®, Kit for the preparation of 68Ga-PSMA-11) for prostate cancer imaging in Chinese patients has completed patient enrolment.

The Phase 3 Illuccix China study[1] is a prospective, open-label, single-arm, multicenter study conducted in collaboration with Telix's strategic partner for the Greater China region, Grand Pharmaceutical Group Limited (Grand Pharma). The study, which enrolled 140 patients, aims to demonstrate equivalence of TLX591-CDx in imaging prostate cancer in Chinese and Western patients, in order to bridge to the marketing authorization granted to Illuccix by the United States (U.S.) Food and Drug Administration (FDA). The data will be used to file a marketing authorization application for TLX591-CDx with the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE).

Dr. David N. Cade, Group Chief Medical Officer, Telix, commented, "We are pleased to have completed this study in collaboration with Grand Pharma, which brings advanced PSMA-PET imaging one step closer for men living with prostate cancer in China. We extend our gratitude to the principal investigators, their clinical research teams, and the patients who participated in this important Phase 3 study."

About Prostate Cancer in China

The Asia Pacific region comprises approximately one third of the world's male population and includes many nations whose populations are ageing or increasingly adopting a more affluent, "Western-style" lifestyle, the two main demographic trends driving increasing cancer incidence rates. Consequently, the incidence of prostate cancer is increasing in many parts of the region.

In China, more than 134,000 men were diagnosed with prostate cancer in 2022[2], increasing by approximately 6% each year[3]. In line with government policy supporting wider geographic access to nuclear medicine, the number of PET/CT cameras installed in China is estimated to have reached 1,240 by the end of 2023, compared with 133 in 2010[4].

About Grand Pharmaceutical Group Limited

Grand Pharma is an international pharmaceutical company of technological innovation. Its core businesses cover three major areas: Pharmaceutical technology; nuclear medicine anti-tumor diagnosis and treatment; and cerebro-cardiovascular precision interventional diagnosis and treatment technology and biotechnology. Based on the pharmaceutical and biological industries, Grand Pharma focuses on the needs of patients, and takes technological innovation as the driving force. In response to the unmet clinical needs, Grand Pharma will increase its investment in global innovative products and advanced technologies, enrich and improve its product pipelines, consolidate and strengthen its supply chain, and fully leverage the Group's industrial strengths and R&D capabilities to provide more advanced and diverse treatment solutions to patients worldwide.

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).

Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix's first generation PSMA-PET imaging agent, has been approved by the U.S. FDA[5], by the Australian Therapeutic Goods Administration (TGA)[6], by Health Canada[7], by the Brazilian Health Regulatory Agency (ANVISA)[8], by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)[9], by the French National Agency for the Safety of Medicine and Health Products (ANSM) and in multiple countries within the European Economic Area (EEA)[10] following a positive decentralized procedure (DCP) opinion by the German medical regulator, BfArM[11].

©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.

[1] ClinicalTrials.gov ID: NCT05847348

[2] Global Cancer Statistics 2022: GLOBOCAN survey. Published August 2024.

[3] Ye Dingwei et al. Lancet Oncology, 2022.

[4] Goetz Partners research 2020.

[5] Telix ASX disclosure 20 December 2021.

[6] Telix ASX disclosure 2 November 2021

[7] Telix ASX disclosure 14 October 2022.

[8] Telix ASX disclosure 18 March 2025.

[9] Telix ASX disclosure 13 February 2025.

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

[11] Telix ASX disclosure 17 January 2025.

Source: 

Telix Pharmaceuticals Limited