FDA grants breakthrough status to Norroy kidney cancer imaging agent

WUXI, China, Aug. 19, 2026 /PRNewswire/ -- NORROY BIOSCIENCE (NORROY), a clinical-stage biotechnology company focused on innovative targeted radiopharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) has granted both Breakthrough Therapy and Fast Track designations to NORROY's 68Ga-NYM096, a potential radiopharmaceutical imaging agent targeting carbonic anhydrase Ⅸ (CAⅨ) for PET imaging of clear cell renal cell carcinoma (ccRCC).

68Ga-NYM096 is the first China-originated innovative radiopharmaceutical to receive FDA Breakthrough Therapy Designation. It is being developed as a non-invasive PET imaging agent to enable the characterization of indeterminate renal masses identified by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) and support the differentiation of ccRCC from non-ccRCC lesions.

The granting of this Breakthrough Therapy designation recognizes the potential of 68Ga-NYM096 to provide meaningful clinical advantages over current diagnostic approaches based on preliminary clinical data, while addressing significant unmet clinical needs in the diagnosis and management of patients with ccRCC. The Fast Track designation is designed to facilitate the development and expedite the review of 68Ga-NYM096 by enabling more frequent interactions with the FDA, enhanced regulatory guidance throughout the clinical development process, and potential eligibility for rolling review of a New Drug Application (NDA).

Clear cell renal cell carcinoma is the most common subtype of renal cell carcinoma (RCC), accounting for approximately 70%–80% of RCC cases. According to the American Cancer Society, in 2026, an estimated 80,450 new cases of kidney (renal) cancer will be diagnosed in the US, and 15,160 people will die from the disease.

NORROY Founder and CEO, Mr. Peng Fang, said: "We have seen promising clinical data from the ongoing development of 68Ga-NYM096, supporting its potential to advance the diagnosis and management of patients with ccRCC. Additional clinical data of 68Ga-NYM096 will be presented at the 2026 EANM Annual Congress. We plan to initiate Phase I clinical trials evaluating 68Ga-NYM096 in both China and the United States, and will continue to work closely with the FDA to advance its clinical development. We believe this innovative imaging agent has the potential to reshape the diagnosis and management of ccRCC and ultimately benefit more patients worldwide."

To learn more about NORROY, visit https://www.norroybiopharm.com/
and follow us on LinkedIn: https://www.linkedin.com/company/norroybiopharm/