MELBOURNE, Australia, Aug. 2, 2022 /PRNewswire/ -- 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
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
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.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, Switzerland, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.
Telix Investor Relations
This announcement has been authorised for release by Dr. Christian Behrenbruch, Managing Director and Group Chief Executive Officer.
This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical studies, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the ASX or on our website.
To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to publicly update or revise any forward-looking statements contained in this announcement, whether as a result of new information, future developments or a change in expectations or assumptions.
The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).
1 ASX disclosure 21 July 2022.2 Globocan 2021.3 Goetz Partners research 2020.4 ASX disclosure 20 December 2021.5 ASX disclosure 2 November 2021.6 ASX disclosure 10 December 2021.7 ASX disclosure 16 December 2020.8 ASX disclosure 1 July 2020.