Telix Pharmaceuticals receives China’s nod for Illuccix prostate cancer imaging NDA

The Telix Pharmaceuticals Ltd (ASX: TLX) share price is in focus after the company announced the Chinese regulator has accepted the New Drug Application for Illuccix, Telix’s lead imaging agent for prostate cancer. The pivotal Phase 3 study in China reported a positive predictive value of 94.8% and showed the agent led to a change in treatment for over two-thirds of patients.

What did Telix Pharmaceuticals report?

• The Chinese NMPA has accepted the New Drug Application for Illuccix for prostate cancer imaging.
• Illuccix China Phase 3 study met its primary endpoint, recording a 94.8% positive predictive value in patients with biochemical recurrence.
• 67.2% of patients experienced a change in treatment as a result of Illuccix PSMA-PET imaging.
• Submission was made in partnership with Grand Pharmaceutical Group Limited for the Greater China region.
• The submission seeks a broad label covering multiple stages of prostate cancer care.

What else do investors need to know?

The China pivotal study results confirm Illuccix’s clinical performance in Chinese patients is comparable to outcomes in international studies. Notably, the imaging agent demonstrated strong accuracy even in patients with very low PSA levels and across various metastatic sites.

Prostate cancer remains a major and growing health challenge in China, with diagnoses increasing by about 6% annually. Wider government support for nuclear medicine is expanding imaging access, with a jump in PET/CT camera installations in China in recent years.

What’s next for Telix Pharmaceuticals?

Telix expects to work closely with its partner Grand Pharmaceutical Group and Chinese regulators during the approval process. If successful, the launch of Illuccix in China could significantly expand Telix’s commercial footprint and support its strategy to deliver precision medicine in large and growing markets.

Looking forward, Telix continues to build out its product portfolio and international operations, aiming to address unmet needs in oncology and rare diseases both in China and worldwide.

Telix Pharmaceuticals share price snapshot

Over the past 12 months, Telix shares have declined 57%, trailing the S&P/ASX 200 Index (ASX: XJO) which has risen 6% over the same period.

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The post Telix Pharmaceuticals receives China’s nod for Illuccix prostate cancer imaging NDA appeared first on The Motley Fool Australia.

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Motley Fool contributor Laura Stewart has no position in any of the stocks mentioned. The Motley Fool Australia’s parent company Motley Fool Holdings Inc. has positions in and has recommended Telix Pharmaceuticals. The Motley Fool Australia has recommended Telix Pharmaceuticals. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips. This article was prepared with the assistance of Large Language Model (LLM) tools for the initial summary of the company announcement. Any content assisted by AI is subject to our robust human-in-the-loop quality control framework, involving thorough review, substantial editing, and fact-checking by our experienced writers and editors holding appropriate credentials. The Motley Fool Australia stands behind the work of our editorial team and takes ultimate responsibility for the content published by The Motley Fool Australia.