Telix’s China Entry Hinges on NMPA Approval Amid Rising Prostate Cancer Cases
Telix Pharmaceuticals has achieved a key milestone with China’s NMPA accepting its New Drug Application for Illuccix, a prostate cancer imaging agent backed by strong Phase 3 data. This paves the way for Telix to enter a rapidly growing Chinese market alongside its global approvals.
- NMPA accepts Illuccix NDA for prostate cancer imaging in China
- Phase 3 trial shows 94.8% positive predictive value in Chinese patients
- Over two-thirds of patients had treatment plans changed based on imaging
- Illuccix already approved in US, Australia, Canada, Europe and more
- China’s prostate cancer incidence rising with expanding nuclear medicine access
Regulatory Breakthrough in China
Telix Pharmaceuticals Limited has reached a significant regulatory milestone with the Chinese National Medical Products Administration (NMPA) accepting its New Drug Application (NDA) for Illuccix (TLX591-Px), a prostate cancer imaging agent. This submission, made in partnership with Grand Pharmaceutical Group Limited, marks Telix’s first formal regulatory filing in China, a market of strategic importance given its rising prostate cancer incidence and expanding nuclear medicine infrastructure.
The NDA is supported by data from the Illuccix China Pivotal Phase 3 Registration study, which reported positive topline results in December 2025. The study demonstrated a patient-level positive predictive value (PPV) of 94.8% for detecting tumors in patients experiencing biochemical recurrence of prostate cancer. This high diagnostic accuracy was consistent even in patients with very low prostate-specific antigen (PSA) levels and across various metastatic sites.
Clinical Impact and Market Potential
Importantly, the imaging results led to a change in treatment plans for more than two-thirds of patients, underscoring Illuccix’s potential to significantly influence clinical decision-making in China. This aligns with global trends where PSMA-PET imaging is increasingly replacing conventional methods like bone scans and CT scans as the standard of care for prostate cancer staging and recurrence assessment.
China’s prostate cancer burden is growing, with over 134,000 new diagnoses in 2022 and an annual increase of approximately 6%. Concurrently, the number of PET/CT cameras in China has surged from just 133 in 2010 to over 1,600 by the end of 2025, reflecting government support for broader access to nuclear medicine technologies.
Global Footprint and Strategic Growth
Illuccix is already approved in multiple major markets including the United States, Australia, Canada, Brazil, the UK, and 19 European countries. Telix’s CEO for Precision Medicine, Kevin Richardson, highlighted the submission as a major step in the company’s geographic expansion strategy. The company aims to leverage its global regulatory successes and clinical data to establish a strong foothold in China’s emerging precision medicine landscape.
While the acceptance of the NDA is a critical step, final market impact will depend on the timing and scope of NMPA approval, pricing, reimbursement, and competitive dynamics within China’s nuclear medicine sector. Nonetheless, this development signals Telix’s growing influence in the global prostate cancer imaging market and its commitment to addressing unmet medical needs through innovative radiopharmaceuticals.
Bottom Line?
Telix’s Illuccix NDA acceptance in China sets the stage for a new growth chapter amid rising prostate cancer demand and expanding nuclear medicine access.
Questions in the middle?
- When can investors expect final NMPA approval and commercial launch in China?
- How will pricing and reimbursement be structured in the Chinese healthcare system?
- What competitive challenges might Telix face from local or international imaging agents?
