Hanmi Pharmaceutical said Friday that the FDA has granted orphan drug designation (ODD) to HM15136, the company's investigational new drug for treating congenital hyperinsulinemia.
HM15136, also known as LAPSGlucagon Analog, applied “LAPSCOVERY,” Hanmi's new drug platform technology, and will enter phase 1 clinical phase in the first half of this year.
ODD is a status given to certain medications called orphan drugs, which show promise in the treatment, prevention, or diagnosis of orphan diseases. The designation provides tax and license application fee exemption and grants a monopoly for seven years if it succeeds in becoming the first drug approved in the field.
“Due to the FDA's ODD designation, the company will be able to speed up the development for LAPSGlucagon Analog,” Hanmi CEO Kwon Se-chang said. “We will do our best to commercialize the drug and take up the responsibility of improving the quality of life of patients suffering from the rare disease.”
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