Wuxi, China-based biotechnology company Norroy Bioscience has received both breakthrough therapy and fast-track designations from the U.S. Food and Drug Administration (FDA) for gallium-68 (Ga-68) NYM096, a PET imaging agent for clear cell renal cell carcinoma (ccRCC).
Ga-68 NYM096 targets an overexpressed enzyme in ccRCC called carbonic anhydrase IX and is designed to characterize indeterminate renal masses identified by CT or MRI and differentiate ccRCC from non-ccRCC lesions, the company said. Norroy said Ga-68 NYM096 is the first China-originated radiopharmaceutical to receive FDA breakthrough therapy designation.
The company plans to initiate phase I clinical trials in both China and the U.S. and will present additional data at the 2026 European Association of Nuclear Medicine annual congress to be held October 17 to 21 in Vienna.
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