17 October 2022 | Monday | News
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The IND application was submitted in partnership with Grand Pharmaceutical Group Limited (Grand Pharma), Telix's partner in the Greater China region. The bridging study is required to provide data obtained in a Chinese population to establish that the diagnostic efficacy of TLX591-CDx is equivalent in Chinese and Western populations. This study will enroll up to 110 patients with suspected recurrent prostate cancer and is anticipated to commence in Q1 2023. Positive data from this Phase III bridging study will support a future marketing authorisation application for TLX591-CDx (Illuccix) in China.
Dr David N Cade, CEO Telix Asia Pacific, said "Each year 115,000 Chinese men will be diagnosed with prostate cancer, which makes it the most rapidly rising cancer in terms of incidence and mortality in China. PSMA PET imaging has the potential to profoundly impact the management of this disease, enabling clinicians to detect prostate cancer right throughout the body. This new imaging modality is already recognised in leading clinical practice guidelines, and is being adopted as a standard of care in many parts of the world. We look forward to working closely with our partner Grand Pharma to bring this important product to market in China, where there is currently unmet medical need."