Norroy Bioscience Completes Enrollment for Phase I/II Clinical Trial of In-House Developed Therapeutic Radiopharmaceutical 177Lu-NYM032

Norroy Bioscience today announced the completion of subject enrollment for its Phase I/II clinical trial of 177Lu-NYM032 (NY108), a PSMA-targeted therapeutic radiopharmaceutical candidate developed in-house. The study focuses on patients with metastatic castration-resistant prostate cancer (mCRPC). This milestone reflects Norroy’s continued momentum in developing integrated diagnostic and therapeutic radiopharmaceuticals, with multiple assets achieving significant progress in rapid succession — demonstrating strong R&D capabilities and execution speed.

The ongoing open-label, single-center trial is designed to evaluate the safety, pharmacokinetics, radiation dosimetry, and preliminary efficacy of 177Lu-NYM032 in PSMA-positive mCRPC patients. Its diagnostic counterpart, 68Ga-NYM032 (NY108), has also completed full subject enrollment and dosing in a separate Phase I/II study. The pair — derived from the same precursor structure — enables a true theranostic approach, combining molecular imaging with targeted radioligand therapy for precise and visualized treatment.

Preclinical and investigator-initiated clinical studies involving hundreds of patients have demonstrated promising performance of the 68Ga/177Lu-NYM032 pair. Compared to existing compounds, the combination shows enhanced tumor uptake, improved tumor-to-background ratio, and extended tumor retention time, while rapidly clearing from the bloodstream and normal organs. Preliminary clinical findings suggest therapeutic efficacy at lower radiation doses (15–30 mCi).

Unmet Needs and Market Potential in mCRPC

Prostate cancer incidence in China continues to rise sharply, with faster growth rates in both incidence and mortality compared to global averages. mCRPC represents the end stage of the disease, with a poor 5-year survival rate and a median overall survival of less than three years. Treatment options remain limited.

PSMA has emerged as a key therapeutic target in prostate cancer research. However, no PSMA-targeted radiopharmaceuticals have been approved in China, representing a major unmet clinical need. The international success of Pluvicto® has underscored the significant therapeutic and commercial potential of PSMA-targeted radioligands.

Data recently published in the European Journal of Nuclear Medicine and Molecular Imaging (EJNMMI) confirm the superior pharmacological profile of Norroy’s candidates. 68Ga-NYM032 demonstrated higher tumor uptake than 68Ga-PSMA-617, while 177Lu-NYM032 showed extended tumor retention and rapid clearance from non-target organs.

Advancing Innovation and Globalization in Radiopharmaceuticals

Looking ahead, Norroy Bioscience will continue to advance its clinical pipeline and accelerate the commercialization of its next-generation radiopharmaceuticals. With a mission to pioneer innovation in China-originated nuclear medicine, the company is committed to breaking barriers and shaping the future of integrated theranostics on a global scale.