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.
More than two-thirds of patients (67.2%) experienced changes to their treatment plans following TLX591-Px imaging, highlighting its impact on clinical decision-making.
Kevin Richardson, Telix’s CEO of Precision Medicine, said, "Submitting this NDA, the first for any of our products in China, marks a major milestone for Telix and our partner Grand Pharma. Geographic expansion is central to our growth strategy, and China is a strategically important market."
Prostate cancer is increasingly common in China, with more than 134,000 new cases reported in 2022, rising about 6% annually.
In line with government policy supporting wider access to nuclear medicine, the number of PET/CT scanners in China is projected to have exceeded 1,600 by the end of 2025, up from 133 in 2010.