Korean radiopharmaceutical company DuChemBio said on Monday it has submitted a new drug application to the Ministry of Food and Drug Safety for flotufolastat F18, a diagnostic imaging agent used in prostate cancer. The company said it expects regulatory approval as early as this summer.

Originally developed by Blue Earth Diagnostics (BED), a subsidiary of Italian imaging company Bracco, flotufolastat F18 was approved by the U.S. FDA in 2023 under the brand name Posluma. 

The agent is a positron emission tomography (PET) imaging tracer that binds to prostate-specific membrane antigen (PSMA), a protein frequently overexpressed in prostate cancer cells. 

It allows physicians to visualize areas where the cancer may have spread or recurred after initial treatment, particularly in patients with rising prostate-specific antigen (PSA) levels—a blood marker commonly used in prostate cancer monitoring.

DuChemBio said it plans to manage the full commercialization of flotufolastat F18 in Korea, including regulatory approval, manufacturing, marketing, and sales. If approved, a portion of future revenue will be paid to BED in the form of royalties, the company added.

The product would expand DuChemBio’s radiopharmaceutical lineup alongside Neuraceq and Vizamyl, both used to detect early signs of Alzheimer’s by imaging abnormal protein buildup in the brain.