Hanmi Pharm "Developing Hyperinsulinemia Treatment Designated as Rare Pediatric Drug in the US"

[Asia Economy Reporter Choi Dae-yeol] Hanmi Pharm announced on the 26th that its congenital hyperinsulinism treatment candidate, "Raps Glucagon Analog" (HM15136), has been designated as a Rare Pediatric Disease (RPD) by the U.S. Food and Drug Administration (FDA).

The RPD program is a special FDA initiative established to encourage the development of new drug candidates that prevent or treat rare pediatric diseases. If a candidate drug designated as an RPD receives marketing approval for the specified indication, it earns the right to a Priority Review Voucher (PRV), which allows the FDA to complete the approval review within six months. This voucher can be used advantageously in the approval process for other products and can also be sold or transferred between companies.

The treatment candidate developed by Hanmi was designated as an orphan drug in 2018 and has now additionally been designated as an RPD. The company stated that this increases the likelihood that its innovative drug candidates will benefit from the FDA's expedited drug development special programs.

Congenital hyperinsulinism is a rare disease causing severe and persistent hypoglycemia in newborns and children, occurring in approximately 1 in every 25,000 to 50,000 newborns. About 60% of cases are diagnosed within the first month after birth. There are currently no approved treatments, so many newborns diagnosed early do not receive adequate treatment. The treatment candidate developed by Hanmi focuses on improving the short half-life of glucagon, which promotes glucose synthesis in the body, as well as enhancing solubility and stability under physiological conditions. It is considered the world's first once-weekly glucagon candidate. Currently, a Phase 1 clinical trial for obesity indication is underway in the United States.

Kwon Se-chang, CEO of Hanmi Pharm, said, "Our innovative drug pipeline currently under development has received 12 orphan drug designations from the FDA and EMA," adding, "Through continuous research and development, we will contribute to improving the quality of life for pediatric patients suffering from rare diseases and patients worldwide."

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