Recently, Telix Pharmaceuticals Limited (Telix, ASX: TLX), a key strategic partner of Grand Pharmaceutical Group Limited (Grand Pharma, 0512.HK) in the field of radionuclide-drug conjugate (RDCs), has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for TLX250-CDx, a globally innovative RDC for the diagnosis of clear cell renal cell carcinoma (ccRCC).

Grand Pharma has exclusive rights to the product in Mainland China, Hong Kong SAR, Macau SAR and Taiwan. The application for BLA is another important milestone in the company’s nuclear drug anti-tumor diagnostic and therapeutic field.

TLX250-CDx has been granted Breakthrough Therapy by the US FDA. Therefore, TLX250-CDx is eligible for a rolling review mechanism, with modules required for review submitted in accordance with the U.S. FDA’s predetermined schedule.

The results of the overseas Phase III clinical study of TLX250-CDx indicate that it is expected to provide a highly accurate and non-invasive diagnostic solution for ccRCC, and has the potential to become a new clinical diagnostic standard for ccRCC.

With this approval, TLX250-CDx is expected to become the first targeted radiopharmaceutical imaging agent for kidney cancer in the United States.