Chinese NMPA Approves Pivotal Phase III Study of TLX591-CDx for Prostate Cancer Imaging – QNT Press Release

MELBOURNE, Australia, Oct. 16, 2022 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved an investigational new drug (IND) application to commence a pivotal Phase III registration study of TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11), for the imaging of prostate cancer using Positron Emission Tomography (PET) that will bridge to the marketing authorisation granted to Illuccix® by the United States Food and Drug Administration (FDA).

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 …

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