Hanmi’s new drug for short bowel syndrome gains WHO recognition as 'sonefpeglutide'

Hanmi Pharmaceutical said Monday that the International Generic Name (INN) of its new drug candidate for short bowel syndrome, LAPS GLP-2 analog (HM15912 in development name), has been finalized as “sonefpeglutide.”

Officially listed by the World Health Organization (WHO), sonefpeglutide is a compound of the prefix “ef-,” which refers to the protein to which Hanmi Pharmaceutical's proprietary platform technology “Lapscovery” was applied, and the suffix “-glutide,” which refers to a glucagon-like peptide analog. In the future, all products containing this ingredient will use the generic name sonefpeglutide.

Short bowel syndrome is a rare disorder in which more than 60 percent of the small intestine is missing, causing malabsorption and malnutrition. It affects about 24.5 per 100,000 newborns. In adults, it can occur after surgery due to inflammatory bowel disease, small bowel inflammation, tumors, and trauma.

Hanmi Pharmaceutical is developing sonefpeglutide as the world's first once-monthly treatment for short bowel syndrome, and a global phase 2 clinical trial is now underway. Once commercialized, the new drug is expected to significantly reduce the treatment burden for patients regarding the durability of treatment effect, safety, and convenience of dosing.

In September, Hanmi Pharmaceutical presented the phase 1 study of sonefpeglutide results at the European Society of Parenteral Enteral Nutrition (ESPEN) in Milan, Italy. In a comparative study of patients with severe renal impairment and healthy individuals, both groups showed good tolerability, safety, and similar pharmacokinetic profiles.

“Currently licensed treatments for short bowel syndrome require daily subcutaneous injections and are inaccessible to patients due to the high cost and lack of insurance coverage in Korea,” said Lee Moon-hee, director of the GM Clinical Team at Hanmi Pharmaceutical. “We will continue to work with domestic and international experts to develop sonefpeglutide into a new treatment that can dramatically improve the quality of life for patients with rare diseases.”

Sonefpeglutide received orphan drug designation from the U.S. Food and Drug Administration, the European Medicines Agency, and the Ministry of Food and Drug Safety in 2019. It was subsequently designated as an FDA Pediatric Orphan Drug (RPD) in 2020 and an FDA Fast-Track Development Drug in 2021.