NORROY BIOSCIENCE (NORROY), a clinical-stage biotechnology company focused on innovative targeted radiopharmaceuticals, announced that it has received regulatory clearance from China's National Medical Products Administration (NMPA) to initiate a pivotal Phase III clinical study of ¹⁷⁷Lu-NYM032 in China. ¹⁷⁷Lu-NYM032 is a novel investigational PSMA-targeted, small-molecule therapeutic radiopharmaceutical for radioligand therapy (RLT) independently developed in China.

Led by the Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, a randomized, open-label, multicenter Phase III study is being conducted at multiple sites across China to evaluate the efficacy and safety of ¹⁷⁷Lu-NYM032 in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).

¹⁷⁷Lu-NYM032 has demonstrated promising anti-tumor activities and a favorable safety profile in its Phase I/II clinical study, with the data to be disclosed in a Top-Rated Oral Presentation (TROP) at the 2026 Annual Congress of the European Association of Nuclear Medicine (EANM 26). Previously, the corresponding diagnostic radiopharmaceutical pair, ⁶⁸Ga-NYM032, was dosed in the first patient in a Phase III clinical trial, marking a key milestone in the advancement of the company's integrated prostate cancer theranostic pipeline. The ⁶⁸Ga/¹⁷⁷Lu-NYM032 theranostic pair has also received U.S. FDA Investigational New Drug (IND) clearance.

The pair of diagnostic and therapeutic agents of NYM032 are derived from the same precursor structure, enabling a fully integrated theranostic approach and offering the potential to provide patients with prostate cancer in China with a more precise and coordinated diagnosis and treatment option.

Prostate cancer is the fifth leading cause of cancer death among men worldwide. In 2022, more than 134,000 patients in China were newly diagnosed with prostate cancer, and approximately 47,500 deaths were reported. A substantial proportion of the patients will eventually progress to have metastatic castration-resistant prostate cancer (mCRPC), an aggressive late-stage form of the disease. At that stage, many patients face limited treatment options after exhausting standard-of-care therapies, thus underscoring the substantial unmet medical need for novel targeted radiopharmaceuticals in China.