EJNMMI: Preliminary Study Results of Norroy’s New Generation PSMA-Targeted Theranostic Radiopharmaceutical Released

The European Journal of Nuclear Medicine and Molecular Imaging (EJNMMI) recently published a significant study evaluating the diagnostic and therapeutic potential of Norroy Bioscience’s next-generation theranostic radiopharmaceutical, 68Ga/177Lu-NYM032, for prostate cancer (PCa).

Prostate-specific membrane antigen (PSMA) is a critical biomarker and therapeutic target for prostate cancer. Norroy’s dual-labeled PSMA-targeted small-molecule agents were independently developed using a unified precursor structure, enabling true theranostic integration. With hundreds of research and clinical trial cases completed, 68Ga/177Lu-NYM032 has rapidly emerged following the breakthrough of Pluvicto, showing unmatched advantages and the potential to fill a global gap in the availability of similar agents.

In this study, the diagnostic efficacy of the PET tracer 68Ga-NYM032 was first evaluated in PSMA-positive xenograft tumor models (LNCaP). A comparative analysis was then conducted using 68Ga-PSMA-617 in 10 PCa patients. Finally, the therapeutic potential of 177Lu-NYM032 was assessed in the LNCaP model. Key findings include:

Higher Affinity:

NYM032 was structurally optimized from Norroy’s earlier molecule NYM016. Through ongoing research and validation, Norroy significantly enhanced the compound’s affinity for PSMA.

Higher Tumor Uptake and Improved Target-to-Background Ratios (TBR):

Compared with 68Ga-PSMA-617, 68Ga-NYM032 demonstrated PSMA specificity and significantly higher uptake in LNCaP tumors, bone metastases, and lymph node metastases (median SUVmax in bone metastases: 5.10 vs. 3.88, P<0.001, n=48; in lymph nodes: 7.81 vs. 5.46, n=2). TBR was also slightly higher in both primary and metastatic lesions.

Biodistribution and Retention:

177Lu-NYM032 showed superior uptake and longer retention in tumor tissues within the LNCaP model. Even at a low dose (18.5 MBq/mouse), it effectively inhibited tumor progression. The compound exhibited prolonged tumor retention with rapid clearance from blood and healthy tissues. Early clinical pharmacodynamic data suggest that effective responses can be achieved at relatively low radiation doses (15–30 mCi).

Favorable Safety Profile:

No adverse events were observed in either preclinical or clinical studies.

These findings support the safety and efficacy of 68Ga/177Lu-NYM032 as a novel theranostic radiopharmaceutical for prostate cancer, highlighting its promise as a new treatment option.

Following regulatory approvals in both China and the United States, 68Ga/177Lu-NYM032 has achieved several clinical milestones within just six months, reflecting Norroy’s rapid development pace. The Phase I/II trial for 68Ga-NYM032 has completed enrollment and dosing, and Phase III preparations are well underway.

With the continued progress of clinical studies, 68Ga/177Lu-NYM032 is expected to deliver even more encouraging outcomes. Norroy Bioscience remains fully committed to accelerating clinical development and commercialization of this innovative agent—contributing to the advancement of original Chinese radiopharmaceuticals and offering new options to meet urgent global patient needs.

Both 68Ga and 177Lu-labeled NYM032 were synthesized using the Mortenon M1 automated multi-functional module, independently developed by Sunmao Medical. Labeling was completed within 20 and 40 minutes respectively, with radiochemical purity exceeding 95%.