Telix Pharmaceuticals (ASX: TLX) has announced that China’s National Medical Products Administration (NMPA) Center for Drug Evaluation has accepted the filing of a New Drug Application for Illuccix, the company’s lead prostate cancer imaging agent. The submission, lodged with strategic partner Grand Pharmaceutical Group (00512.HK), seeks a broad label covering multiple stages of prostate cancer care and represents the first Telix product filing in China.
China’s NMPA Accepts Telix’s Illuccix Application for Prostate Cancer Imaging
The NMPA’s acceptance of the New Drug Application (NDA) for TLX591-Px (Illuccix) marks a major regulatory milestone for Telix’s precision medicine business in the strategically important Chinese market. The submission is based on data from the Illuccix China Pivotal Phase 3 Registration study (NCT05847348), which reported positive top-line results in December 2025.
The application covers clinical utility at multiple stages of prostate cancer management, positioning Illuccix as a comprehensive diagnostic tool across the patient journey. This broad label approach differentiates the submission from narrower imaging indications and reflects the technology’s proven versatility in global markets.
Partnership execution with Grand Pharma validates Telix’s market entry strategy for Greater China. The collaboration leverages Grand Pharma’s regional expertise in regulatory navigation and commercial infrastructure while allowing Telix to focus on clinical data generation and product supply.
Key submission highlights include:
- NMPA CDE acceptance achieved, initiating formal review process
- Partnership with Grand Pharma executing on market access strategy
- Broad label application submitted covering multiple prostate cancer stages
- Phase 3 clinical data package supporting Chinese population validation
The acceptance triggers the formal NMPA review process, positioning Illuccix as a potential first-to-market PSMA-PET imaging agent in China pending regulatory approval.
What Are the Clinical Results from Telix’s China Study?
The Illuccix China Pivotal Phase 3 Registration study met its primary endpoint with an overall patient-level positive predictive value (PPV) of 94.8% for detecting tumours in patients with biochemical recurrence (BCR) of prostate cancer. This high accuracy rate validates the clinical experience of TLX591-Px PSMA-PET imaging in Chinese patients as comparable to studies conducted in non-Chinese populations.
Clinical performance remained robust even in patients with very low prostate-specific antigen (PSA) values and across differing metastatic locations. This low-PSA sensitivity expands the addressable patient population by enabling earlier detection of recurrence, when treatment interventions may be most effective.
More than two-thirds (67.2%) of patients experienced a change in their treatment plan following TLX591-Px PSMA-PET imaging compared with the initial plan established at baseline. This treatment impact rate demonstrates major influence on clinical decision-making, a key driver of physician adoption and a metric increasingly scrutinised by health technology assessment bodies evaluating diagnostic technologies.
The study confirmed that PSMA-PET imaging with Illuccix delivers consistent clinical utility regardless of geographic population, removing a potential regulatory and commercial risk factor for China market entry.
| Metric | Result | Clinical Significance | Market Impact |
|---|---|---|---|
| Primary Endpoint PPV | 94.8% | High accuracy in BCR detection | Supports broad label claim |
| Treatment Plan Changes | 67.2% | Major clinical decision impact | Drives physician adoption |
| PSA Performance | Effective at very low levels | Detects early recurrence | Expands addressable market |
| Population Validation | Comparable to non-Chinese studies | Confirms universal utility | Removes geographic risk |
The data package supporting the NDA submission provides clinical evidence aligned with global regulatory precedents established in the United States, Australia, and Europe, where Illuccix has already secured market authorisations.
PSMA-PET Imaging in Prostate Cancer Management
PSMA-PET imaging represents a significant technological advancement in prostate cancer diagnosis and management. The technology combines two components: prostate-specific membrane antigen (PSMA), a protein that appears in high concentrations on prostate cancer cells, and positron emission tomography (PET), a medical imaging technique that creates three-dimensional images of functional processes in the body.
When a radioactive tracer that binds to PSMA is injected into a patient, PET scanners detect the radiation emitted and create detailed images showing exactly where prostate cancer cells are located throughout the body. This allows doctors to see cancer that may have spread to lymph nodes, bones, or other organs with far greater accuracy than older imaging methods.
PSMA-PET has largely replaced conventional imaging methods such as bone scans and computed tomography (CT) scans as the standard of care after initial diagnosis and biochemical recurrence in the United States. Global clinical practice guidelines from the National Comprehensive Cancer Network (NCCN), European Association of Urology (EAU), and European Society for Medical Oncology (ESMO) recognise its superior accuracy in staging primary disease and assessing BCR.
Imaging technology comparison:
- Conventional Imaging: Bone scans and CT scans offer lower sensitivity for detecting small or early-stage cancer spread
- PSMA-PET (Illuccix): Superior accuracy in pinpointing cancer locations, earlier detection capability, and documented impact on treatment decisions in more than 67% of cases based on China study data
This clinical superiority explains why NMPA approval would be material for Telix. The company is bringing proven standard-of-care technology to a high-growth market where imaging infrastructure is rapidly expanding to support nuclear medicine applications.
Global Regulatory Precedent Supporting China Approval Pathway
Illuccix has established a track record of regulatory approvals across multiple major markets, demonstrating a de-risked pathway for NMPA review. The product secured U.S. Food and Drug Administration (FDA) approval in December 2021, followed by Australian Therapeutic Goods Administration (TGA) authorisation in November 2021.
Additional approvals include Health Canada (October 2022), the Brazilian Health Regulatory Agency ANVISA (March 2025), the UK Medicines and Healthcare Products Regulatory Agency MHRA (February 2025), and 19 countries within the European Economic Area. This regulatory precedent validates the safety and efficacy profile underpinning the China submission.
China approval, if granted, would expand Telix’s commercial footprint to a further major geographic region, adding a strategically important market to an already established global presence.
How Will Illuccix Approval Impact China Market Expansion?
China represents a substantial and rapidly growing market opportunity for prostate cancer imaging. More than 134,000 men were diagnosed with prostate cancer in China in 2022 according to the GLOBOCAN survey, with incidence increasing by approximately 6% annually as reported in Lancet Oncology 2022.
This growing patient population is meeting a rapidly expanding imaging infrastructure. The number of PET/CT cameras installed in China is expected to have surpassed 1,600 by the end of 2025 compared to just 133 in 2010, representing more than 12-fold growth in nuclear medicine imaging capacity over 15 years.
Government policy actively supports wider geographic access to nuclear medicine technologies, creating a favourable regulatory and reimbursement environment for advanced diagnostic tools. This policy alignment removes a significant market entry barrier and supports the commercial case for PSMA-PET adoption across China’s healthcare system.
The convergence of rising prostate cancer incidence, expanding PET/CT infrastructure, and supportive government policy creates conditions for first-mover advantage in the PSMA-PET imaging segment. Telix’s partnership with Grand Pharma positions the company to capitalise on this market development if NMPA approval is secured.
“Submitting this New Drug Application for TLX591-Px, the first for any of our products in China, is a major milestone for Telix and our partner Grand Pharma. Geographic expansion is core to the growth strategy for our precision medicine business, and China represents a strategically important market for Telix,” said Kevin Richardson, CEO Precision Medicine, Telix.
What Does NMPA Acceptance Mean for Telix Shareholders?
NDA acceptance by the NMPA Center for Drug Evaluation represents procedural validation that the submission package meets technical filing requirements, triggering the formal review process. This is distinct from approval, which remains contingent on NMPA’s scientific assessment of the clinical data and manufacturing quality standards.
NMPA review timelines vary depending on the classification of the application and whether the agency requests additional data or clarifications during the assessment process. Telix has not provided specific guidance on expected approval timing.
The acceptance validates the strategic execution of the Grand Pharma partnership, demonstrating that the collaboration can navigate China’s regulatory framework effectively. This de-risks the market entry pathway for potential future Telix products targeting the Chinese market.
From an investment thesis perspective, China entry addresses several strategic priorities:
Next steps in the China commercialisation pathway:
- NMPA review process now underway following acceptance
- Grand Pharma partnership managing regulatory progression and stakeholder engagement
- Commercial preparation activities expected during review period, including pricing and reimbursement strategy
- Market launch planning contingent on NMPA approval outcome
Illuccix’s Established Commercial Performance Context
Illuccix has been approved by the U.S. Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA), Health Canada, the Brazilian Health Regulatory Agency (ANVISA), the UK Medicines and Healthcare Products Regulatory Agency (MHRA), and in 19 countries within the European Economic Area (EEA). The China opportunity represents expansion of a validated asset with approvals across multiple markets, rather than commercialisation of an unproven product.
This context reduces execution risk relative to a new product launch. The company is applying learnings from existing markets to a new geography, supported by local partnership infrastructure and clinical data specific to the Chinese patient population.
For shareholders, the investment case centres on geographic revenue diversification, expansion of commercial footprint for the company’s lead imaging product, and strategic validation of the Greater China partnership model. China approval would compound existing Illuccix market presence with access to a market of 134,000+ annual prostate cancer diagnoses growing at 6% annually, supported by 1,600+ installed PET/CT cameras and favourable government policy settings for nuclear medicine access.
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Telix’s NMPA filing demonstrates the type of precision medicine progress reshaping Australian biotech. For investors tracking non-resource ASX sectors—from healthcare innovation to fintech disruption—staying ahead of regulatory milestones and clinical data releases is essential for identifying value before the market fully reacts.
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