China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that its Investigational New Drug (IND) filing for TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11), a radionuclide-drug conjugate (RDC) for the diagnosis of prostate cancer, has been approved by the National Medical Products Administration (NMPA). This approval marks a significant step forward in the development of innovative diagnostic tools for prostate cancer.
Drug Profile and Development
TLX591-CDx, originally developed by Australia-based Telix Pharmaceuticals Ltd, is a novel RDC diagnostic that targets prostate-specific membrane antigen (PSMA). It is under development to diagnose metastatic and recurrent prostate cancer. The drug was licensed to Grand Pharma in a November 2020 deal worth up to USD 250 million. TLX591-CDx features internalization into cells, stable biological activity, a short half-life in circulation, good permeability to tumor parenchyma, and rapid clearance by non-targeted tissues. The drug was approved in Australia in November 2021 and is also approved in the US, Brazil, and Canada, with reviews ongoing in 16 countries.
Clinical Study and Safety Data
A Phase I clinical study concluded in February 2023 in Japan showed that TLX591-CDx was safe and well tolerated. There was no significant difference between Japanese and Western populations in systemic and organ-specific radiation dosimetry and pharmacokinetics data. The approval of the IND means that a clinical bridging study will be carried out in China, assessing the safety and tolerance of the product in more than 100 prostate cancer patients with biochemical recurrence after radical prostatectomy and/or radical radiotherapy. The study will also include PET/CT or PET/MRI testing to provide support for the product’s marketing in China.
Future Outlook
The approval of TLX591-CDx by the NMPA underscores Grand Pharmaceutical Group’s commitment to advancing innovative diagnostics for prostate cancer. By conducting a clinical bridging study in China, Grand Pharma aims to gather additional data to support the product’s market entry and improve diagnostic options for patients with prostate cancer.-Fineline Info & Tech
