[Edaily Reporter NA EUN-KYUNG ] DuChemBio Co.,LTD.(176750)announced on the 24th that it has completed the registration of the main raw material (Fluoropropyl-CIT [18F]) for the Parkinson’s disease PET diagnostic agent “18F-FP-CIT” with the U.S. Food and Drug Administration (FDA) Drug Master File (DMF).

The company explained that with this registration, it has secured the foundation necessary for supplying the raw material in the United States, the world’s largest radiopharmaceutical market. Following the registration process, the FDA assigned the DMF number “MF044308” to the raw material.

A DMF is a system for registering information on the manufacturing process and quality control of pharmaceutical raw materials with the FDA. DMF registration of raw materials is required to license and manufacture drugs in the United States, and developers of finished pharmaceutical products can utilize the registered data during the licensing process.

DuChemBio Co, LTD announced that it currently holds the global rights to 18F-FP-CIT and has signed technology transfer agreements covering 12 countries in the Asia-Pacific region. The company plans to use this DMF registration as an opportunity to expand its technology export partnerships targeting the North American market.

18F-FP-CIT is a PET diagnostic agent that uses the radioactive isotope fluorine-18 (F-18) to image dopamine transporters in the brain; it is used to diagnose degenerative brain diseases such as Parkinson’s disease.

According to the company, it also received a decision in May to grant a U.S. patent for artificial intelligence (AI)-based technology that generates early diagnostic images for 18F-FP-CIT. This technology is designed to enhance testing efficiency by predicting and generating images showing the point at which drug distribution is complete, based solely on initial scan images.

Kim Sang-woo, CEO of DuChemBio Co, LTD, stated, “Following the acquisition of global rights to 18F-FP-CIT and the securing of clinical and regulatory data, this FDA DMF registration has laid the groundwork for our entry into the U.S. market.” He added, “Since finished-product manufacturers can utilize the registration data without having to prepare separate raw material-related documentation, we plan to expand negotiations for global technology exports.”

He added, “While pursuing entry into the North American market based on AI imaging technology and the registration of the active pharmaceutical ingredient, we will also expand the competitive edge we have established in Parkinson’s disease diagnostics to the field of Alzheimer’s disease diagnostics.”