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Telix APAC Report: Regulatory Progress for Prostate and Kidney Cancer Imaging

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Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) 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).1

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.”

About prostate and kidney cancer in the Asia Pacific region

The Asia Pacific region comprises approximately one third of the world’s male population and includes many nations whose populations are ageing or increasingly adopting a more affluent, “Western-style” lifestyle, the two main demographic trends driving increasing cancer incidence rates. Consequently, the incidence of prostate cancer is increasing in many parts of the region.

In South Korea, over 13,000 men are diagnosed with prostate cancer each year.2

In China, 115,000 men are diagnosed with prostate cancer each year, increasing by approx. 6% each year and 73,000 people are diagnosed with renal cell carcinoma each year.

In line with government policy supporting wider geographic access to nuclear medicine, the number of PET/CT cameras installed in China is forecast to reach 1,110 by the end of 2022, compared with 133 in 2010.3

About Illuccix® (TLX591-CDx)

Illuccix (TLX591-CDx) is a preparation for imaging prostate cancer with positron emission tomography (PET), targeting prostate specific membrane antigen (PSMA), a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells. Illuccix enables PSMA-11 to be labelled with the radionuclide Ga-68 directly before injection by medical professionals. After preparing the radiopharmaceutical and injecting it into the patient, PSMA positive lesions are localised by PET imaging.

Illuccix has been approved by the U.S. Food and Drug Administration (FDA),4 and by the Australian Therapeutic Goods Administration (TGA).5 Telix is also progressing marketing authorisation applications for this investigational candidate in Europe6 and Canada.7

About TLX250-CDx

TLX250-CDx (89Zr-girentuximab) is an investigational product being developed by Telix for the purpose of non-invasive detection of clear cell renal cancer in patients with “indeterminate renal masses” (IDMRs), typically identified based on computed tomography (CT) or magnetic resonance imaging (MRI) imaging and are an increasing medical dilemma as more scans are performed and more IDRMs are identified.

Girentuximab is a monoclonal antibody that targets carbonic anhydrase IX (CA9), a cell surface target that is highly expressed in several human cancers including renal, lung and oesophageal cancers. In July 2020, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy (BT) designation for TLX250-CDx,8 reflecting the significant unmet clinical need to improve the diagnosis and staging of clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer.

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