[Edaily Reporter Kwon Oh Seok ] DuChemBio Co.,LTD.(176750)’s stock price surged to the daily upper limit early in the trading session. It appears that buying interest is surging following news that the company has completed registration of the active pharmaceutical ingredient (Fluoropropyl-CIT [18F]) for its Parkinson’s disease diagnostic agent “18F-FP-CIT” with the U.S. Food and Drug Administration (FDA).

According to MP Doctor on the 24th, as of 9:08 a.m., DuChemBio Co, LTD is trading at the daily price limit of 7,310 won, up 29.84% from the previous trading day.
Earlier that day, the company stated in a press release, “With this, we have secured the raw material requirements necessary for supply to North America, the world’s largest radiopharmaceutical market.”
FDA registration of active pharmaceutical ingredients is considered a prerequisite for entering the U.S. market. This is because, in order to manufacture and supply finished pharmaceutical products in the U.S., a Drug Master File (DMF) containing information on the manufacturing process and quality of the active ingredient must be registered; furthermore, the approval process requires the disclosure of supplier information and proof of manufacturing facilities. Through this procedure, the FDA assigned the unique number “MF044308” to DuChemBio Co, LTD’s primary active ingredient.
“18F-FP-CIT” is a PET (positron emission tomography) diagnostic agent based on the radioactive isotope fluorine-18 (F-18) that binds to dopamine transporters in the brain to aid in the early diagnosis of degenerative brain diseases such as Parkinson’s disease. High-performance liquid chromatography (HPLC) is used in the production of the active ingredient to precisely separate the target compound from impurities, and manufacturing conditions and records are meticulously managed to ensure consistent quality.
CEO Kim Sang-woo emphasized, “We have finalized technology transfer agreements for 18F-FP-CIT with 12 countries in the Asia-Pacific region, and with this FDA DMF registration, we have met the requirements for entering the world’s largest market.” He added, “Since our finished-drug partners can refer to the registration data without having to prepare separate raw material documentation, we will accelerate negotiations for technology exports.”