Shares in Telix Pharmaceuticals Ltd (ASX: TLX) are trading higher after the company announced good news out of China for its prostate cancer imaging compound, Illuccix.
The company said in a statement to the ASX on Tuesday that China's National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has accepted a new drug application (NDA) for Illuccix, which is Telix's lead prostate cancer imaging agent.
The company said further:
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 3 Registration study1, which reported positive top-line results in December 2025.
Telix said the China study met its primary endpoint, "with an overall patient-level positive predictive value of 94.8% for the detection of tumours in patients with biochemical recurrence of prostate cancer".
This confirmed, the company said, that the compound worked in a comparable way in Chinese patients and non-Chinese patients.
Telix said the high predictive value was demonstrated even in patients with very low prostate-specific antigen readings "and across differing metastatic locations''.
More than two-thirds (67.2%) of patients experienced a change in their treatment plan as a consequence of (Illuccix) imaging compared with the initial plan at baseline, demonstrating a major impact on clinical decision-making in Chinese patients.
Major step forward
Telix Chief Executive Officer, Precision Medicine, Kevin Richardson, said it was a significant outcome for the company.
Submitting this New Drug Application for (Illuccix), 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 said more than 134,000 men were diagnosed with prostate cancer in China in 2022, with that number increasing by about 6% each year.
The company said that in line with Chinese government policy supporting wider geographic access to nuclear medicine, the number of cameras used in the Illuccix imaging process was expected to have surpassed 1600 by the end of 2025, up from 133 in 2010.
Illuccix has already been approved by the US Food and Drug Administration, Australia's Therapeutic Goods Administration, the United Kingdom Medicines and Healthcare Products Regulatory Agency, and in 19 countries within the European Economic Area.
Telix shares were 3.7% higher at $11.70 in early trade.
Telix was valued at $3.82 billion at the close of trade on Monday.
