Grand Pharmaceutical’s Innovative Radiopharmaceutical TLX591-CDx for Prostate Cancer Diagnosis Meets Primary Clinical Endpoints in China Phase III Trial
Journalist: Zhang Min | December 21, 2025
December 21, 2025 — Grand Pharmaceutical Group Limited (0512.HK), a Hong Kong-listed company, announced that its innovative Radionuclide Drug Conjugate (RDC) for prostate cancer diagnosis, TLX591-CDx (Illuccix®, gallium Ga68 PSMA-11), has achieved positive top-line results and successfully met its primary clinical endpoints in a Phase III trial conducted in China.
According to the announcement, TLX591-CDx is a globally innovative diagnostic radiopharmaceutical based on radionuclide-small molecule conjugate technology targeting Prostate-Specific Membrane Antigen (PSMA). It is indicated for the diagnosis of both newly diagnosed and recurrent prostate cancer.
The Phase III study was a single-arm, open-label trial involving over 100 patients with biochemical recurrence (BCR) of prostate cancer. The study utilized PET/CT or PET/MRI imaging following TLX591-CDx administration to evaluate the product's diagnostic efficacy, safety, and tolerability within the Chinese population.
Grand Pharma noted that TLX591-CDx was first approved in Australia (November 2021) and the United States (December 2021), and has since gained approval in Canada, Brazil, the UK, and other regions. Financial data shows that TLX591-CDx generated sales of approximately US$517 million in 2024. In the first three quarters of 2025, sales reached approximately US$461 million, representing a year-on-year growth of over 25%.
The success of the Phase III trial in China marks a pivotal step in Grand Pharma’s strategy to build an "Integrated Diagnosis and Treatment" portfolio for prostate cancer. Regarding treatment, the company’s other innovative RDC, TLX591, has been approved to join an international multi-center Phase III study in China. The combination of these two products is expected to provide Chinese patients with more precise and efficient diagnostic and therapeutic solutions, creating strong commercial synergies and solidifying Grand Pharma's dominance in the nuclear medicine sector.
Prostate cancer is among the most common cancers in Chinese men, with rising incidence and mortality rates attributed to an aging population. Data from Frost & Sullivan predicts that the incidence of prostate cancer in China could exceed 165,000 cases by 2030, with the market size for related drugs reaching approximately RMB 37.6 billion.
Currently, Grand Pharmaceutical has established a comprehensive presence in the radiopharmaceutical oncology sector, spanning R&D, production, distribution, and sales. Its pipeline includes 16 innovative products in the R&D or registration stages, involving five radionuclides (68Ga, 177Lu, 131I, 90Y, and 89Zr) across seven cancer types, including liver, prostate, and brain cancers.
As the global radiopharmaceutical market continues to expand, Grand Pharmaceutical aims to leverage its first-mover advantage and full-chain capabilities to further its "Go Global" strategy, expanding its global market share and providing superior oncology solutions worldwide.

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