Telix shares lift after China regulator accepts Illuccix prostate imaging application

Key highlights

• China’s NMPA (CDE) has accepted Telix’s New Drug Application (NDA) for Illuccix (TLX591-Px, 68Ga-PSMA-11) for prostate cancer imaging. 
• The filing is being progressed with Grand Pharmaceutical Group as Telix’s Greater China partner. 
• Telix says its China Phase 3 study reported an overall positive predictive value (PPV) of 94.8% in biochemical recurrence patients, and 67.2% of participants had a treatment-plan change after the scan. 
• On the ASX, TLX was up 3.28% to $11.65 around 12:26pm AEDT, on volume of 2.39m shares (per the data provided).
  
   

Telix Pharmaceuticals’ share price surged on Tuesday after the company disclosed a meaningful regulatory step in China: the country’s drug regulator has accepted the New Drug Application for Illuccix, Telix’s prostate cancer imaging agent used in PSMA-PET scans. 

In regulatory terms, “accepted” is not the same as approved, but it matters. It signals the dossier has cleared an initial gate and is now in the formal review system, which is often a prerequisite before timelines and review milestones come into view.

What exactly was accepted in China?

Telix said the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) has accepted the NDA for TLX591-Px (Illuccix, Kit for the preparation of 68Ga-PSMA-11). 

The application was submitted with Telix’s Greater China partner Grand Pharmaceutical Group Limited (Grand Pharma). 

Illuccix is a diagnostic tool, not a treatment: it helps clinicians see prostate cancer more clearly by imaging a target called PSMA (prostate-specific membrane antigen) using PET scanning. Telix notes that PSMA-PET imaging has increasingly displaced older “standard” imaging approaches, such as bone scans and CT, in certain settings because it can be more accurate for staging and recurrence assessment. 

The data Telix highlighted: why PPV and “treatment plan change” matter

In its statement, Telix pointed to the Illuccix China Pivotal Phase 3 Registration study, saying it reported positive top-line results in December 2025 and met its primary endpoint. 

The company reported:

• Overall patient-level PPV of 94.8% for detecting tumours in patients with biochemical recurrence (BCR) of prostate cancer. 
• High PPV even in patients with very low PSA values and across different metastatic locations. 
• 67.2% of patients had a change in treatment plan after PSMA-PET imaging compared to the baseline plan. 
  
   

PPV is about how often a positive scan result is confirmed as true disease. A high PPV figure suggests the imaging is frequently picking up real tumour activity when it flags something. The “treatment plan change” number is also practical: it suggests the scan results often provide information that alters what doctors decide to do next, whether that is surgery, radiation planning, systemic therapy, or closer monitoring.

CEO comment: “major milestone” and the strategic angle

Telix framed this as its first product NDA in China, and positioned it within a broader “geographic expansion” theme. The company’s CEO for Precision Medicine, Kevin Richardson, said:

Source: Telix Company Announcement

The “subject to NMPA approval” line is the key qualifier: the acceptance moves the process forward, but the commercial outcome still depends on the regulator’s review.

Market reaction: modest lift, but against a tougher 12-month backdrop

The market’s immediate response was positive. Based on the pricing snapshot provided, TLX traded at $11.65 (+3.28%) around 12:26pm AEDT, with 2.39m shares traded and a market cap listed at $3.95bn.

Even so, the same snapshot shows the stock is down 55.36% over one year with a 52-week range of $10.89 to $31.97. That context matters because it helps explain why a single regulatory step can support the price on the day, but does not automatically rewrite the market’s longer-term debate around growth, competition, margins, and execution across multiple products and geographies.

Why China matters

Telix included key data-points about the size and direction of the China opportunity:

• It said more than 134,000 men were diagnosed with prostate cancer in China in 2022, and cited growth of roughly 6% per year. 
• It also said PET/CT installations in China were expected to have surpassed 1,600 by end-2025, compared with 133 in 2010. 
  
   

What to watch next

From here, the signposts are straightforward and mostly procedural:

1. Regulatory progress: timelines, questions from the regulator, and any stated review milestones. (Acceptance starts the review; it does not conclude it.) 
   
    
2. Commercial readiness with the partner: even with approval, rollout depends on distribution, hospital uptake, and operational execution. (Telix is partnering via Grand Pharma for Greater China.) 
   
    
3. Evidence and adoption: whether clinicians adopt the scan as intended, and whether the “treatment plan change” impact observed in the study translates into real-world decision-making at scale.