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Chinese NMPA Approves Study of Telix Kidney Cancer Imaging Candidate

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Chinese NMPA Approves Study of Telix Kidney Cancer Imaging Candidate | Pharmtech Focus

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 a pivotal Phase III registration study that will bridge to Telix’s global Phase III ‘ZIRCON’ trial of TLX250-CDx (89Zr-girentuximab), for the imaging of clear cell renal cell carcinoma (ccRCC) with position emission tomography (PET).

The investigational new drug (IND) application was submitted by Telix’s partner in the Greater China region, Grand Pharmaceutical Group Limited (Grand Pharma). The bridging study is required to provide “supplementary” data obtained in a Chinese population to establish that the diagnostic efficacy of this investigational product is equivalent in Chinese and Western populations. A dosimetry study enrolling 10 patients will precede the multi-centre Phase III bridging study, which is expected to enrol 100 patients.

A successful outcome from Telix’s global ZIRCON trial combined with positive data from this Phase III bridging study will support a future marketing authorisation application for TLX250-CDx in China.

Dr. David N Cade, CEO Telix  Asia Pacific, said “This IND is a significant milestone for Telix and our partner Grand Pharma, enabling us to proceed with a pivotal registration study and ultimately bring new options to the 73,000 people newly diagnosed with renal cell carcinoma in China each year where there is currently critical unmet medical need.”

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