Telix Pharmaceuticals (ASX:TLX) has taken a significant step toward expanding access to advanced prostate cancer imaging in China, with the country’s drug regulator formally accepting a new drug application for the company’s lead diagnostic product, Illuccix.
The Chinese National Medical Products Administration’s Center for Drug Evaluation has accepted the filing for TLX591-Px, marketed internationally as Illuccix, a gallium-68–based PSMA-PET imaging agent used in the detection and management of prostate cancer. The application was submitted in partnership with Grand Pharmaceutical Group, Telix’s strategic collaborator for the Greater China region, marking Telix's first regulatory filing in China.
The submission seeks a broad product label reflecting Illuccix’s utility across multiple stages of prostate cancer care. It is supported by data from the China Pivotal Phase 3 Registration study, which reported positive top-line results in late 2025. In that study, Illuccix met its primary endpoint, achieving an overall patient-level positive predictive value of 94.8 per cent for detecting tumours in men experiencing biochemical recurrence of prostate cancer. Importantly, the results demonstrated strong performance even in patients with very low prostate-specific antigen levels and across a range of metastatic sites, confirming consistency with outcomes previously observed in non-Chinese populations.
Beyond diagnostic accuracy, the study highlighted the agent’s clinical impact. More than two-thirds of participants experienced a change in their treatment plan following PSMA-PET imaging with Illuccix, underscoring its influence on clinical decision-making and personalised patient management in the Chinese healthcare setting.
Telix characterised the filing as a major milestone in the company’s global growth strategy. With geographic expansion a core priority for its precision medicine business, Telix views China as a strategically important market, given the country’s rising prostate cancer incidence and rapidly expanding nuclear medicine infrastructure. Subject to regulatory approval, the company aims to bring Illuccix to market in China to address the growing needs of men living with prostate cancer.
The timing of the application aligns with broader healthcare trends in China. Prostate cancer diagnoses have been increasing steadily, and government support for nuclear medicine has driven rapid growth in PET/CT capacity nationwide. This infrastructure expansion positions advanced imaging technologies such as PSMA-PET to play a more prominent role in cancer diagnosis and management.
Illuccix is already approved in multiple major markets, including the United States, Australia, Canada, the United Kingdom, Brazil, and countries across the European Economic Area. Globally, PSMA-PET imaging has largely supplanted conventional bone scans and CT imaging as the standard of care in key clinical settings, supported by international clinical guidelines that recognise its superior accuracy in staging and recurrence detection.