Norroy Bioscience has received approval from the National Medical Products Administration (NMPA) to start a Phase III clinical trial in China for 177Lu-NYM032, a prostate-specific membrane antigen (PSMA)-targeted small-molecule radioligand therapy.
The study will assess the efficacy and safety of 177Lu-NYM032 in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).
The randomised, open-label, multi-centre trial will be led by Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and will take place at several centres in China.
Initial clinical results for 177Lu-NYM032 from earlier Phase I/II studies suggested anti-tumour activity and a favourable safety profile.
Further data are set to be presented at the 2026 Annual Congress of the European Association of Nuclear Medicine (EANM 26).
Norroy Bioscience has also developed a related diagnostic radiopharmaceutical, 68Ga-NYM032, which has been administered to its first patient in a separate Phase III trial.
This represents further progress in the company's integrated prostate cancer theranostic strategy.
Additionally, the 68Ga/177Lu-NYM032 combination has secured investigational new drug (IND) clearance from the US Food and Drug Administration (FDA).
The NYM032 diagnostic and therapeutic radiopharmaceuticals are derived from a single precursor structure, forming an integrated approach intended to support both diagnosis and therapy for prostate cancer in China.
Norroy Bioscience develops therapeutic and diagnostic radiopharmaceuticals, as well as systems for radiopharmaceutical manufacturing. Its clinical programmes target more than ten disease areas, including urological and gastrointestinal oncology.
The FDA has previously granted breakthrough therapy and fast track designations to the company’s kidney cancer imaging agent, 68Ga-NYM096.
The company reports that it has obtained six IND clearances from the FDA and six investigational new drug approvals from the NMPA and is advancing further clinical development of its candidates through international clinical trials.
