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Illuccix China Phase 3 Study Completes Enrolment

2025-07-10 00:40:09阅读时长3分钟1381字

Illuccix China Phase 3 Study Completes EnrolmentIlluccix China Phase 3 Study Completes EnrolmentAustralia and the United States English Technology and HealthNews Source: Yahoo Finance2025-07-10 00:40:09 Reading Time 3 minutes 1381 wordsProstate Cancer Health Illuccix China Phase 3 Study PSMA-PET Imaging Technology Grand Pharma Telix Pharmaceuticals Prostate Cancer Incidence Cancer Treatment Radiopharmaceuticals Medical NeedsTelix Pharmaceuticals Ltd.

(ASX: TLX, NASDAQ: TLX, "Telix", the "Company") today announced that the pivotal Phase 3 registration study of prostate cancer imaging in Chinese patients, TLX591-CDx (Illuccix®, 68Ga-PSMA-11 Preparation Kit), has completed patient enrollment.The Illuccix China Phase 3 study [1] is a prospective, open-label, single-arm, multi-centre study conducted by Telix in collaboration with its strategic partner in Greater China, Grand Pharma Group Co., Ltd. (Grand Pharma). The study enrolled 140 patients and was designed to demonstrate equivalence of TLX591-CDx in imaging prostate cancer in China and the West in order to bridge the path to U.S. Food and Drug Administration (FDA) marketing authorization for Illuccix.

The data will be used to submit a marketing authorization application for TLX591-CDx to the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE).Dr. David N. Cade, Chief Medical Officer of Telix Group, commented: “We are pleased to have collaborated with Yuanda Pharmaceuticals on this study, which brings Chinese prostate cancer patients closer to advanced PSMA-PET imaging technology. We are grateful to the principal investigators, their clinical research team, and the patients who participated in this important Phase 3 study.”

About Prostate Cancer in ChinaThe Asia-Pacific region accounts for approximately one-third of the global male population and includes many countries that are aging or increasingly adopting a more affluent ‘Western’ lifestyle, two demographic trends that are driving rising cancer rates. As a result, prostate cancer rates are rising in many parts of the region.In China, more than 134,000 men will be diagnosed with prostate cancer in 2022[2], an annual increase of approximately 6%[3]. In line with government policies to support wider geographical coverage of nuclear medicine, the number of PET/CT scanners installed in China is estimated to have reached 1,240 by the end of 2023, compared to just 133 in 2010[4].About Yuanda Pharmaceutical Group Co., Ltd.Yuanda Pharmaceutical is an international, technology-innovative pharmaceutical company. Its core businesses cover three areas: pharmaceutical technology; nuclear medicine anti-tumor diagnosis and treatment; and cardiovascular and cerebrovascular precision interventional diagnosis and treatment technology and biotechnology. Based on the pharmaceutical and biotechnology industries, Yuanda Pharmaceutical is patient-centered and driven by technological innovation to address unmet clinical needs. Yuanda Pharmaceutical will increase investment in global innovative products and advanced technologies, enrich and improve its product pipeline, consolidate and strengthen its supply chain, and fully leverage the Group's industrial advantages and R&D capabilities to provide more advanced and diversified treatment solutions for patients around the world.

About Telix Pharmaceuticals Ltd.Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and related 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 pipeline of clinical and commercial-stage products designed to address significant unmet medical needs in oncology and rare diseases. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are all Telix Group companies. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).

Telix’s first-generation PSMA-PET imaging agent, Illuccix® (gallium-68 (68Ga) gozetotide injection preparation kit), has been approved by the US FDA[5], the Australian Therapeutic Goods Administration (TGA)[6], Health Canada[7], the Brazilian Health Regulatory Agency (ANVISA)[8], the UK Medicines and Healthcare Products Regulatory Agency (MHRA)[9], the French National Agency for the Safety of Medicines and Health Products (ANSM), and multiple European Economic Area (EEA) countries[10] following a decentralized procedure (DCP) under the leadership of the German medical regulator BfArM[11].For more information about Telix, including the latest share price, ASX and SEC filings, investor and analyst presentations, press releases, event details and other publications, please visit www.telixpharma.com. You can also follow Telix on LinkedIn, X and Facebook.(End of article)