Hanmi Pharmaceutical's New Drug for Danjang Syndrome Designated as Pediatric Orphan Drug by US FDA

[Asia Economy Reporter Cho Hyun-ui] Hanmi Pharmaceutical announced on the 30th that LAPS GLP-2 Analog (HM15912), a biopharmaceutical drug under development for the treatment of short bowel syndrome, has been additionally designated as a Rare Pediatric Disease (RPD) by the U.S. Food and Drug Administration (FDA).

Hanmi Pharmaceutical is developing the drug with the goal of once-monthly administration, based on improved in vivo durability and excellent villous cell growth-promoting effects. Short bowel syndrome is a rare disease caused by the congenital or acquired loss of more than 60% of the entire small intestine, leading to malabsorption and malnutrition.

This designation is the second following the designation of LAPS Glucagon Analog (a biopharmaceutical drug for congenital hyperinsulinism) as an RPD on the 24th.

Hanmi Pharmaceutical is currently conducting a Phase 1 clinical trial of HM15912 for the indication of short bowel syndrome in South Korea and plans to start Phase 2 clinical trials in the U.S. and Europe in the second half of this year. HM15912 was designated as a rare disease drug for the treatment of short bowel syndrome by the FDA and the European Medicines Agency (EMA) last year.

Kwon Se-chang, CEO of Hanmi Pharmaceutical, said, “Through continuous research and development and expansion of indications, we will dramatically improve the quality of life for patients suffering from rare diseases worldwide.”

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