Telix Pharmaceuticals (ASX:TLX) announced that China's National Medical Products Administration has accepted its New Drug Application for TLX591-Px (Illuccix, Kit for the preparation of 68Ga-PSMA-11), the company's lead prostate cancer imaging agent.
The submission was made in partnership with Grand Pharmaceutical for the Greater China region and seeks a broad label covering multiple stages of prostate cancer care.
The NDA includes data from the Illuccix China Pivotal Phase 3 Registration study, which reported positive top-line results in December 2025.
The study met its primary endpoint, showing a patient-level positive predictive value of 94.8% for detecting tumors in patients with biochemical recurrence of prostate cancer.
The findings demonstrated that TLX591-Px PSMA-PET imaging in Chinese patients delivers clinical results comparable to non-Chinese populations, even in patients with very low PSA levels and varying metastatic locations.