Norroy Bioscience Receives FDA Clearance for IND Applications of Two Proprietary Radiopharmaceuticals Targeting Prostate Cancer

Norroy Bioscience has recently received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for two proprietary theranostic radiopharmaceuticals, 68Ga/177Lu-NY108 (NYM032). The company secured three clinical trial approvals within just a few days—highlighting its strong R&D capabilities and accelerated innovation pace.

68Ga/177Lu-NY108 (NYM032) is a high-affinity small-molecule compound targeting Prostate-Specific Membrane Antigen (PSMA), developed from a single molecular precursor. It is indicated for metastatic castration-resistant prostate cancer (mCRPC). The diagnostic and therapeutic isotopes can be combined to enable integrated imaging and radionuclide therapy. Preclinical and early clinical studies have demonstrated the compound’s strong potential and advantages in the field of prostate cancer theranostics. As a next-generation theranostic radiopharmaceutical, 68Ga/177Lu-NY108 (NYM032) is poised to offer patients a more precise, safer, more effective, and cost-efficient treatment option.

In addition to NYM032, Norroy’s innovative radiotherapeutic agent for kidney cancer—68Ga-NY104 (NYM005)—along with 177Lu-NY108, has also received clinical trial approvals in both China and the United States. These milestones mark significant progress for original Chinese radiopharmaceutical innovations on the global stage.

Looking ahead, Norroy Bioscience plans to submit at least three IND applications annually and will continue advancing key milestones for both approved and pipeline programs. The company remains committed to bringing breakthrough theranostic solutions to market as quickly as possible—delivering new hope and better outcomes to patients worldwide.