Hanmi Pharm’s First-in-Class Drug for Rare Disease Selected for National New Drug Development Program


A view of Hanmi Pharm headquarters (courtesy of Hanmi Pharm)

Hanmi Pharm announced that LAPS Glucagon Analog (HM15136) under development for treatment of congenital hyperinsulinism (CHI) has been chosen for the national new drug development program by the Korea Drug Development Fund (KDDF).

The national new drug development program is aimed at providing support throughout the entire process for new drug development, based on an open innovation strategy involving pharmaceutical companies, universities, research institutes, and hospitals.

Hanmi Pharm will be provided state funding for global clinical trials and commercialization of CHI treatment agent over the course of 24 months.

CHI is a rare disease affecting one in every 25,000 to 50,000 people, and there is currently no treatment agent that has been approved. Patients, therefore, must use unapproved medications while risking adverse effects or opt for surgery.

LAPS Glucagon Analog is a long-acting glucagon derivative that is being developed to become the world’s first single-dose drug for CHI. LAPScovery, Hanmi’s platform technology that boosts the efficacy and prolongs the effectiveness of a biological, was applied.

The analog dramatically improves the residence time of glucagon, which promotes glucose synthesis in the body.

“We’ll speed up the development process so that [LAPS Glucagon Analog] can be commercialized as the world’s first therapeutic agent for a rare disease for which there is currently no treatment by proving its effectiveness in the Phase 2 clinical trial that is currently being carried out with child patients in the United States,” said Kwon Se-chang, President and co-CEO of Hanmi Pharm.

Source: Newsis