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).