Hanmi Pharm Selected for National Support Drug Development Project for 'Congenital Hyperinsulinism Treatment New Drug'

Hanmi Pharm Headquarters View (Photo by Hanmi Pharm)

[Asia Economy Reporter Chunhee Lee] Hanmi Pharmaceutical's rare disease treatment new drug 'LAPS Glucagon Analog (HM15136)' has been selected for the national support new drug development industry.

Hanmi Pharmaceutical announced on the 8th that LAPS Glucagon Analog, being developed as an innovative new drug for congenital hyperinsulinism, has been selected as a project of the National New Drug Development Foundation's national new drug development program. The national new drug development program is a government-wide national research and development (R&D) project that supports all stages of new drug development based on an open innovation strategy involving pharmaceutical companies, academia, research institutes, and hospitals.

With this project selection, Hanmi Pharmaceutical will receive national research funding for 24 months to conduct global clinical trials and product development research for the treatment of congenital hyperinsulinism. Congenital hyperinsulinism is a rare disease occurring in approximately 1 in 25,000 to 50,000 people. Since there are no approved treatments to date, patients have relied on off-label drugs with side effects or surgical interventions.

LAPS Glucagon Analog is a long-acting glucagon derivative being developed with the goal of once-weekly administration, the first in the world. It applies Hanmi Pharmaceutical's proprietary platform technology 'LAPSCOVERY,' which significantly improves the short half-life of glucagon that promotes glucose synthesis in the body.

In clinical trials conducted so far, LAPS Glucagon Analog has shown superior safety compared to existing glucagon drugs. Normal blood glucose levels were continuously maintained even in models exhibiting severe hypoglycemia. Based on these results, LAPS Glucagon Analog was designated as an orphan drug for congenital hyperinsulinism by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2018. Subsequently, last year, EMA designated it as an orphan drug for insulin autoimmune syndrome, and the FDA designated it as a rare pediatric disease (RPD) drug.

Kwon Se-chang, CEO of Hanmi Pharmaceutical, said, "The National New Drug Development Foundation, launched for global commercialization, highly evaluated the potential of Hanmi Pharmaceutical's rare disease new drug, enabling us to proceed with new drug development more dynamically. We will accelerate development to prove innovative results in the ongoing Phase 2 clinical trial in pediatric patients and commercialize it as the world's first treatment in the unmet rare disease field with no existing therapies."