The randomized, open-label, multicenter trial will be led by the Peking Union Medical College Hospital. It aims to evaluate the safety and efficacy of the PSMA-targeted small-molecule agent in patients who have exhausted standard-of-care options. Previous Phase I/II data, which showed promising anti-tumor activity and a manageable safety profile, will be presented at the 2026 European Association of Nuclear Medicine congress.
Norroy Bioscience Launches Phase III Trial for PSMA-Targeted Therapy
China's National Medical Products Administration has cleared Norroy Bioscience to begin a pivotal Phase III clinical trial for 177Lu-NYM032, a radioligand therapy designed to treat metastatic castration-resistant prostate cancer. The study marks a significant progression for the company’s domestic theranostic pipeline in the treatment of aggressive late-stage disease.
This therapy is part of a broader theranostic pair alongside 68Ga-NYM032, which is also currently in Phase III testing. By utilizing the same precursor structure for both diagnosis and treatment, Norroy intends to offer a more precise clinical pathway for the 134,000 patients newly diagnosed with prostate cancer in China annually. With the disease remaining a leading cause of cancer death among men, the development of targeted radiopharmaceuticals addresses a critical gap in oncology care. Norroy, founded in 2021, currently holds 12 total IND clearances across its global portfolio, including multiple approvals from both the NMPA and the U.S. FDA.
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