• Telix's lead prostate cancer imaging agent Illuccix accepted for filing by Chinese NMPA
• Positive top-line results from Illuccix China Pivotal Phase 3 Registration study
• Illuccix demonstrated high positive predictive value (PPV) of 94.8% in detecting tumors

Telix Pharmaceuticals Limited announced that the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has accepted the filing of a New Drug Application (NDA) for TLX591-Px (Illuccix®, Kit for the preparation of 68Ga-PSMA-11), Telix's lead prostate cancer imaging agent. The NDA was submitted with Telix's strategic partner for the Greater China region, Grand Pharmaceutical Group Limited. The submission includes data from the Illuccix China Pivotal Phase 3 Registration study, which reported positive top-line results in December 2025. The Illuccix China study met its primary endpoint, with an overall patient-level positive predictive value (PPV) of 94.8% for the detection of tumors in patients with biochemical recurrence (BCR) of prostate cancer with TLX591-Px. This confirmed that the clinical experience of TLX591-Px PSMA-PET imaging in Chinese patients is comparable to studies in non-Chinese patients. The high PPV was demonstrated even in patients with very low PSA values, and across differing metastatic locations. More than two-thirds (67.2%) of patients experienced a change in their treatment plan as a consequence of TLX591-Px PSMA-PET imaging compared with the initial plan at baseline, demonstrating a major impact on clinical decision-making in Chinese patients.

Telix did not provide any high-importance, price-sensitive forward-looking financial metrics in the announcement.

Telix did not provide any forward-looking outlook in the announcement.