APAC Report: Regulatory Progress for Prostate and Kidney Cancer Imaging

Melbourne (Australia) – 2 August 2022. Telix announces Regulatory Progress in the APAC Operating Region for Prostate and Kidney Cancer Imaging

Telix today reports on regulatory progress for the Company’s core prostate and kidney cancer imaging programs in the Asia Pacific (APAC) Operating Region, including progress in the major market of China with its strategic partner Grand Pharmaceutical Group Limited (Grand Pharma).

TLX591-CDx (Illuccix®) for prostate cancer imaging

  • China: An Investigational New Drug (IND) application has been submitted  by Telix’s partner in Greater China, Grand Pharma, to the National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) – and accepted for review – for a pivotal Phase III registration study that will bridge to the United States Food and Drug Administration (FDA) approval of Illuccix.
  • South Korea: As previously reported, an imported New Drug Application (NDA) has been submitted by Telix’s partner in South Korea, DuChemBio Co, Ltd. (DuChemBio), to the Ministry of Food and Drug Safety (MFDS) for TLX591-CDx (Illuccix®, Kit for the preparation of 68Ga-PSMA-11), a radiopharmaceutical targeting Prostate-Specific Membrane Antigen (PSMA) for the imaging of prostate cancer using Positron Emission Tomography (PET).

TLX250-CDx for kidney cancer imaging

  • China: An IND application has been submitted by Grand Pharma to the NMPA CDE (and accepted for review) for 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 renal cell carcinoma (RCC) with position emission tomography.

The Phase III bridging studies of TLX591-CDx and TLX250-CDx are required to provide “supplementary” data in an exclusively Chinese population to establish that efficacy of these investigational products is equivalent in Chinese and Western populations. It is expected that both studies will be multi-centre, enrolling approximately 100 patients.

“Together with our partners, we are pleased to report delivery of these material regulatory milestones, including submitting a first NDA for PSMA imaging in Asia. Additionally, we have made significant progress in China, following a thorough consultation process with the NMPA, and have filed our first IND applications in this important market. The expertise and strong support of our partners Grand Pharma and DuChemBio has enabled an efficient process and the delivery of these milestones within target timelines,” said Dr David N. Cade, CEO Telix Asia Pacific. “The Asia Pacific region represents a major market opportunity, being driven by increasing cancer incidence rates and an investment in installation of PET/CT cameras in markets such as China and India. We are committed to bringing targeted radiation imaging and therapies to patients in need across the region.”

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