Norroy's Kidney Cancer Radiopharmaceutical 18F-NYM005 Receives IND Approval from the U.S. FDA

Norroy’s Global First-in-Class Kidney Cancer Radiopharmaceutical 18F-NYM005 Receives IND Approval from the U.S. FDA

Clear cell renal cell carcinoma (ccRCC) is the most prevalent histological subtype of kidney cancer. Early diagnosis and accurate staging are critical for improving patient outcomes. However, conventional diagnostic methods such as CT, MRI, and biopsy have limitations, and 18F-FDG PET/CT shows suboptimal sensitivity for kidney cancer imaging.

Carbonic anhydrase IX (CAIX) has emerged as a promising target for the diagnosis and treatment of kidney cancer. Norroy Bioscience has spent five years advancing innovation in this field, having developed four generations of CAIX-targeted molecules, validated through thousands of animal models and over 300 clinical research cases. The company now holds a global leading position in the CAIX-targeted radiopharmaceutical development landscape.

18F-NYM005, Norroy’s investigational PET imaging agent, binds CAIX with high specificity and affinity. In early-stage clinical research involving over 100 subjects, it has demonstrated encouraging results. With a longer half-life than 68Ga, the 18F radionuclide enables centralized production and broader distribution, supporting a scalable supply model through global partnerships. 18F-NYM005 is expected to offer enhanced accuracy for early diagnosis and treatment response monitoring in ccRCC, contributing to improved clinical decision-making.

Within just two years, Norroy has obtained seven IND approvals across China and the United States. Multiple investigational radiopharmaceuticals are now progressing rapidly toward late-stage clinical development, reflecting the company’s strong innovation capability and swift response to unmet medical needs.

Norroy’s founder Dr. Peng Fang stated:

"We will continue close collaboration with regulatory agencies including the NMPA and FDA, and work with global partners to develop first-in-class radiopharmaceuticals that meet urgent clinical needs. By exploring new radionuclides and next-generation diagnostic and therapeutic strategies, we aim to accelerate clinical development and commercialization of innovative radiopharmaceuticals, making novel radiotherapeutics more accessible to patients worldwide."