Telix Pharmaceuticals secures China approval for prostate cancer imaging filing
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The news: Biotech company Telix Pharmaceuticals has received clearance from the Chinese National Medical Products Administration (NMPA) and the Center for Drug Evaluation (CDE) to proceed with the filing of a drug application for its lead prostate cancer imaging agent TLX591-Px, commercially known as Illuccix.
The context: The Illucix filling was submitted by Telix's Chinese partner, Grand Pharmaceutical Group, and seeks a broad label covering multiple stages of prostate cancer.
The submission includes data from the Illucix 'China Pivotal Phase 3 Registration study', which reported an overall patient-level predictive value of 94.8% for the tumour detection in patients with biochemical recurrence of prostate cancer in December 2025.
The approval follows findings published from The Lancet Oncology, which showed more than 134,000 men were diagnosed with prostate cancer in China in 2022, with cases forecast to increase by around 6% annually.
What they said: "Submitting this new drug application for TLX591-Px 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," Telix Pharmaceuticals CEO Kevin Richardson said.
The source: ASX
