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Telix’s Illuccix Prostate Cancer Imaging NDA Accepted for Review in China

Story Highlights
  • Telix and Grand Pharma’s Illuccix prostate imaging NDA has been accepted by China’s NMPA, marking Telix’s first product filing in this key market.
  • Pivotal Chinese Phase 3 data showed high diagnostic accuracy and major treatment-plan impact, underscoring Illuccix’s potential in a fast-growing prostate cancer market with expanding PET/CT capacity.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Telix’s Illuccix Prostate Cancer Imaging NDA Accepted for Review in China

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Telix Pharmaceuticals ( (AU:TLX) ) has provided an announcement.

Telix Pharmaceuticals and its Greater China partner Grand Pharmaceutical Group have had their New Drug Application for TLX591-Px (Illuccix) accepted for review by China’s National Medical Products Administration, marking Telix’s first product filing in the Chinese market and a key step in its geographic expansion strategy. The submission, based on a pivotal Phase 3 study in Chinese patients with biochemically recurrent prostate cancer, demonstrated a high positive predictive value of 94.8% for tumor detection and triggered changes in treatment plans for more than two-thirds of participants, suggesting Illuccix could materially influence clinical decision-making in a rapidly growing prostate cancer market that is expanding at around 6% annually and supported by significant national investment in PET/CT imaging infrastructure.

The most recent analyst rating on (AU:TLX) stock is a Hold with a A$12.50 price target. To see the full list of analyst forecasts on Telix Pharmaceuticals stock, see the AU:TLX Stock Forecast page.

More about Telix Pharmaceuticals

Telix Pharmaceuticals is a Melbourne-headquartered biopharmaceutical company specialising in therapeutic and diagnostic radiopharmaceuticals and related medical technologies, with a portfolio targeting significant unmet needs in oncology and rare diseases. The company’s lead product, Illuccix, a first-generation PSMA-PET imaging agent for prostate cancer, is already approved across major markets including the United States, Australia, Canada, Brazil, the United Kingdom and multiple European countries, underpinning Telix’s position in advanced prostate cancer imaging globally.

YTD Price Performance: 2.50%

Average Trading Volume: 1,723,295

Technical Sentiment Signal: Sell

Current Market Cap: A$3.89B

Find detailed analytics on TLX stock on TipRanks’ Stock Analysis page.

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