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Telix Advances China Market Entry for Illuccix Prostate Cancer Imaging

Telix Pharmaceuticals Limited (ASX: TLX) has reached a key regulatory milestone with the acceptance of a New Drug Application by China’s National Medical Products Administration for Illuccix®, its lead prostate cancer imaging agent. Filed in partnership with Grand Pharmaceutical Group, the application is supported by positive results from a Phase 3 China registration study, which demonstrated a high diagnostic accuracy in detecting recurrent prostate cancer. The study showed strong clinical utility across patient subgroups, including those with low PSA levels, and materially influenced treatment decisions in a majority of cases. Acceptance of the application marks Telix’s first regulatory filing in China and aligns with its strategy to expand geographically in precision medicine. With prostate cancer incidence rising and nuclear medicine infrastructure expanding rapidly in China, regulatory progress for Illuccix positions Telix to address a growing unmet clinical need while strengthening its global footprint in radiopharmaceutical diagnostics.

 

 

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