Korean pharmaceutical and biotech companies seek to enter the market for rare diseases through the orphan drug designation. Th rare disease field has a small pool of patients, but companies can obtain an exclusive status by acquiring innovative new drugs when they succeed and create high-added value. New drug candidates from various companies, including Hanmi Pharm, GC Biopharma, GI Innovation, and Rznomics, successfully obtained the U.S. Food and Drug Administration (FDA)'s Orphan Drug Designation (ODD).

According to industry sources on December 16, twenty-one new drug candidates under development by Korean pharmaceutical and biotech companies received ODD from the FDA. ODD provides companies developing t