Hanmi Pharm "New Drug for Short Bowel Syndrome Treatment Designated FDA Fast Track"

Hanmi Pharmaceutical Headquarters (Provided by Hanmi Pharmaceutical)

[Asia Economy Reporter Chunhee Lee] Hanmi Pharmaceutical announced on the 7th that its short bowel syndrome treatment 'LAPS GLP-2 Analog (code name HM15912)' has been designated as a Fast Track by the U.S. Food and Drug Administration (FDA).

Short bowel syndrome is a rare disease caused by congenital or acquired surgical resection resulting in the loss of more than 60% of the entire small intestine, leading to malabsorption and consequent malnutrition. It occurs in approximately 24.5 out of every 100,000 newborns, with a survival rate below 50%. Artificial nutritional supplementation is necessary for growth and life maintenance.

Hanmi Pharmaceutical plans to accelerate the development of this innovative treatment through the Fast Track designation. Fast Track is a procedure implemented by the FDA to expedite the development and early supply of important new drugs for the treatment of serious diseases. Drugs designated as Fast Track can receive necessary support through consultations with the FDA at each development stage, enabling faster commercialization.

Additionally, drugs designated as Fast Track benefit from a 'rolling review' process, allowing sequential submission of approval materials as they become available when applying for marketing authorization. Furthermore, if clinical data are adequately prepared, the company can negotiate with the FDA for priority review designation, which shortens the review period from 10 months to 6 months.

HM15912 was previously designated as an orphan drug by the FDA and the European Medicines Agency (EMA) in 2019, and last year it was also designated as a Rare Pediatric Disease (RPD) by the FDA.

Based on the confirmed in vivo persistence and villous cell growth-promoting effects from domestic Phase 1 clinical trials, Hanmi Pharmaceutical plans to initiate global Phase 2 clinical trials in the U.S. and Europe.