Grand Pharmaceutical Group Limited (HKG: 0512) announced that the National Medical Products Administration (NMPA) has accepted Investigational New Drug (IND) filings for TLX591-CDx (Illuccix) and TLX250-CDx, its radiopharmaceuticals for prostate cancer and clear cell renal cell carcinoma (ccRCC) diagnostics.
Drug Profiles
- TLX591-CDx: Targets prostate-specific membrane antigen (PSMA) using radionuclide-small molecule coupling technology. Approved in Australia (Nov 2021) and the U.S. (Dec 2021), with special authorization in Brazil. A bridging study in China will enroll over 100 patients with biochemically recurrent prostate cancer for PET/CT or PET/MRI imaging.
- TLX250-CDx: Targets carbonic anhydrase IX (CA9) in urological malignancies using radionuclide-antibody conjugation. Granted Breakthrough Therapy Designation (BTD) in the U.S. (July 2020). Overseas Phase III study enrolled 300 subjects (July 2022), with results expected this year.
China Trials
- TLX591-CDx: Phase I study in China will assess diagnostic efficacy and safety in patients post-prostatectomy/radiotherapy.
- TLX250-CDx: Phase I trial will evaluate safety, radiation dosimetry, and pharmacokinetics in 10 patients with indeterminate renal masses. A confirmatory study will involve 98 patients undergoing PET/CT imaging to assess diagnostic accuracy.
Global Development
TLX591-CDx is filed for marketing in 17 countries. TLX250-CDx’s overseas Phase III study will conclude this year, with China trials supporting local market filing.-Fineline Info & Tech
