Chinese NMPA accepts New Drug Application for Illuccix for prostate cancer imaging – Telix Pharmaceuticals

Telix Pharmaceuticals Limited announces that the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has accepted the filing of a New Drug Application (NDA) for TLX 591-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.  Seeking a broad label that reflects clinical utility at multiple stages of prostate cancer care, the submission includes data from the Illuccix China Pivotal Phase III 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 TLX 591-Px. This confirmed that the clinical experience of TLX 591-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 TLX 591-Px PSMA-PET imaging compared with the initial plan at baseline. demonstrating a major impact on clinical decision-making in Chinese patients.

Kevin Richardson, Chief Executive Officer, Precision Medicine, Telix, commented, “Submitting this New Drug Application for TLX591-Px, the first for any of our products in China, is a major milestone for Telix and our partner Grand Pharma. Geographic expansion is core to the growth strategy for our precision medicine business, and China represents a strategically important market for Telix. We look forward to progressing regulatory approvals together with Grand Pharma and subject to NMPA approval, bringing our lead commercial imaging product to market in China to serve the needs of men living with prostate cancer.”