Telix Pharmaceuticals Ltd (ASX:TLX) says Chinese regulators have accepted a New Drug Application (NDA) for its lead prostate cancer imaging product, Illuccix (TLX591-Px), in a move that could open a significant new market for the radiopharmaceuticals group.
The company said the National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has accepted the filing for TLX591-Px (Illuccix, kit for preparation of 68Ga-PSMA-11), which was submitted with its Greater China partner, Grand Pharmaceutical Group Limited (00512.HK).
Phase 3 data underpins filing
The NDA seeks a broad label covering clinical use across multiple stages of prostate cancer care and includes data from the Illuccix China pivotal Phase 3 registration study, which reported positive top-line results in December 2025.
The China study met its primary endpoint, delivering an overall patient-level positive predictive value (PPV) of 94.8% for tumour detection in patients with biochemical recurrence (BCR) of prostate cancer using TLX591-Px PSMA-PET imaging.
Results indicate the performance of TLX591-Px in Chinese patients is comparable to outcomes reported in non-Chinese populations. Telix also pointed to strong PPV in patients with very low PSA levels and across different metastatic sites.
Telix said imaging with TLX591-Px led to a change in treatment plan for 67.2% of patients compared with the initial plan at baseline, which it said highlights a “major impact” on clinical decision-making.
China a key expansion market
Kevin Richardson, chief executive officer, Precision Medicine at Telix, said the submission was the company’s first NDA filing for any Telix product in China.
“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.”
Telix also highlighted growth in prostate cancer incidence and imaging infrastructure in China, citing more than 134,000 diagnoses in 2022 and an estimated annual increase of about 6%.
The company noted the number of PET/CT cameras installed in China is expected to have surpassed 1,600 by the end of 2025, compared with 133 in 2010.
Product footprint
Illuccix (gallium-68 gozetotide injection, also known as 68Ga-PSMA-11) has been approved in multiple markets including the US, Australia, Canada, Brazil, the UK and 19 countries in the European Economic Area, Telix said.
Telix is headquartered in Melbourne and develops and commercialises diagnostic and therapeutic radiopharmaceuticals targeting oncology and rare diseases.