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  • Numerous K-Bio drugs secure FDA ODD
  • by Son, Hyung Min | translator Hong, Ji Yeon | Dec 18, 2024 05:55am
11 in the first half of 2024¡¤10 in the second half of 2024 receive ODD from the FDA
Companies target various diseases, including solid cancers¡¤pulmonary hypertension¡¤Wilson's disease¡¤Lafora disease
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 treatments fo
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