Hanmi’s Hyperinsulinism Medicine Designated as Orphan Drug by U.S. FDA

Hanmi Pharmaceutical announced that its LAPSGlucagon Analog (HM15136) was designated as an orphan drug by the U.S. Food and Drug Administration on February 1.

The Orphan Drug Designation (ODD) by the U.S. FDA is to facilitate the development and authorization of medicines for rare incurable diseases. The system includes tax incentives and new drug application fee exemption. In addition, the first one authorized in each product category is given exclusive rights valid for seven years starting from the date of approval.

The LAPSCOVERY, Hanmi Pharmaceutical’s technology for biomedicine development, is applied to LAPSGlucagon Analog. The first clinical phase is scheduled for the first half of this year.

“The designation by the U.S. FDA will accelerate our development of the medicine,” said Hanmi Pharmaceutical CEO Kwon Se-chang, adding, “We will do our utmost for the commercialization of the medicine so that the pain of patients suffering from rare diseases can be alleviated.”