Telix Pharmaceuticals (ASX:TLX) China Regulatory Progress Emerges After a 55% Sell-Off

The China Regulatory Path Is Still Moving Forward

Telix Pharmaceuticals (ASX:TLX) has had a challenging start to the year, with the share price down around 55% and now trading near A$11.70 at the time of writing. In our experience, this is often when a stock becomes worth revisiting. Sustained share price weakness can create opportunities, particularly when the underlying business continues to make progress that may not yet be reflected in the valuation.

Today, Telix announced that a New Drug Application for Illuccix has been accepted. It is important to be clear on what this means. This announcement relates to the acceptance of the application following completion of the formal technical review. It is a meaningful regulatory milestone, but it is not the same as full approval.

This step confirms that the submission has met the required standards to move forward in the regulatory process. While further review is still required before commercial approval can be granted, acceptance reduces regulatory uncertainty and keeps Illuccix on track within the broader approval pathway.

At this stage, the announcement does not change near term fundamentals on its own. However, it does reinforce that Telix continues to execute against its regulatory objectives.

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Strong China Data Reinforces the Illuccix Investment Case

What also stands out in the announcement are the clinical outcomes from the Phase 3 registration study, which provide important context around the strength of the Illuccix data. The study reported a patient-level positive predictive value of 94.8% for tumour detection, highlighting a high degree of diagnostic accuracy. This basically means when the scan identified prostate cancer in a patient, it was right 94% of the time.

Telix also noted that performance in Chinese patients was comparable to outcomes seen in non-Chinese studies, which meaningfully reduces the need for extensive ethnic bridging.

Crucially, the data suggests Illuccix is not just accurate, but clinically impactful. Around 67% of patients experienced a change in treatment plan compared to baseline intent. For investors, this is an important signal. It implies the scan is influencing real world clinical decision making, rather than simply confirming existing diagnoses.

The announcement also highlighted two key demand enablers in the Chinese market. In 2022, there were approximately 134,000 prostate cancer diagnoses in China, with incidence growing at around 6% per year. This points to a large and expanding addressable patient population.

At the same time, PET/CT infrastructure is scaling rapidly, with installations expected to exceed 1,600 units by the end of 2025. As a result, commercial uptake is likely to be driven less by disease awareness and more by practical factors such as site enablement, access, and reimbursement.

What needs to happen now

For investors asking what Telix needs to do next to move into the Chinese market, the answer is that the pathway is clear, but execution matters. As with most biotech commercialisations, this phase is operationally complex rather than conceptually uncertain.

From a regulatory standpoint, the priority is continued execution. This includes establishing China compliant pharmacovigilance and post market safety reporting processes, as well as maintaining rapid and responsive engagement with the CDE as information requests arise. Timely turnaround here is critical to keeping the approval process moving without delays.

On the manufacturing side, Telix needs to lock down kit manufacturing at scale, alongside quality control, release specifications, and China compliant documentation. This work sits behind the scenes, but it is essential to ensuring the product can be reliably supplied once commercial approval is granted.

Commercially, the focus shifts to building a viable pricing pathway and pursuing reimbursement inclusion routes. With awareness already high and imaging infrastructure expanding, success in China is likely to hinge on access, site enablement, and reimbursement rather than clinician education.

What are the other analysts saying

The key takeaway is that this announcement represents another major milestone ticked off for Telix. After a difficult and bearish year for the stock, we believe this is an appropriate time to begin researching and revisiting the opportunity. Consensus broker sentiment remains supportive, with eight Buy ratings, four Strong Buy ratings, and one Hold. The average price target sits around A$25, implying meaningful upside from current levels. At these prices, the risk-to-reward profile appears considerably more attractive than it did at prior highs.

This is not financial advice and reflects our personal opinion only, shared to help retail investors think more clearly about the opportunity and make better informed investment judgments.