The U.S. Food and Drug Administration has granted an orphan drug designation (ODD) status to Hanmi's HM15912, a drug candidate for short bowel syndrome.
|Hanmi headquarters in Bangi-dong, eastern Seoul.|
The FDA's ODD is a system that helps smoothe the development and approval of therapeutic drugs for rare or life-threatening diseases. ODD drugs receive tax holidays, exemption of license application fees, and seven-year monopoly after obtaining authorization.
Short bowel syndrome is a malabsorption disorder caused by a dysfunctional small intestine. Infants are either born with the condition or develop it due to surgery for necrotizing enterocolitis, while adults can develop the syndrome either through intestinal resection due to mesenteric vascular disease or Crohn's disease.
The most common symptoms are diarrhea, malnutrition, dehydration, foul-smelling stool, and weight loss. Its severe cases can also lead to death.
With the ODD status for HM159129, Hanmi has four ODD drugs, including HM15136, a congenital hyperinsulinemia treatment, HM43239 for acute myeloid leukemia, and Oraxol, an oral anticancer drug for angiosarcoma.
"As the company's new drugs continue to acquire ODD status, the future value of Hanmi's pipeline is expanding and solidifying," Hanmi Pharmaceutical's President-CEO Kwon Se-chang said. "Our company will speed up development for patients suffering from the disease."