Hanmi Pharm said the Ministry of Food and Drug Safety (MFDS) has approved its phase 3 clinical trial plan for efpeglenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, to treat obesity.

After submitting an investigational new drug (IND) application to the MFDS in July, Hanmi was able to secure speedy approval for the study through various support programs run by the ministry.

The company utilized the MFDS's "Global Innovative Products on Fast Track (GIFT)" system, which provided a close communication opportunity with regulatory authorities, pre-resolving many potential issues.

Efpeglenatide, based on Hanmi's proprietary LAPSCOVERY platform, is a once-weekly GLP-1 formulation. The drug acts as an analog of the GLP-1 hormone found in the body, promoting insulin secretion and suppressing appetite.

After exporting its technology to Sanofi as a diabetes treatment candidate in 2015, efpeglenatide's efficacy in weight loss and blood sugar control was verified in a large-scale global phase 3 trial. It was also found to reduce the incidence of major cardiovascular and renal diseases significantly.

These findings were subsequently published in esteemed journals, including the New England Journal of Medicine (NEJM).

Despite the drug's efficacy, Sanofi returned the rights of efpeglenatide in 2020.

Given the drug's already confirmed global potential, Hanmi aims to commercialize efpeglenatide domestically within three years, with production planned at their Pyeongtaek Smart Plant.

Unlike imported obesity treatments facing global shortages, Hanmi expects to supply efpeglenatide at a more economical cost, ensuring stable availability and significantly enhancing access and adherence for obese patients.

Meanwhile, Hanmi had recently initiated the H.O.P (Hanmi Obesity Pipeline) Project, exploring comprehensive treatment approaches spanning from obesity treatment to prevention.

Efpeglenatide is set to be the first commercial model from this project. The H.O.P Project also encompasses innovative treatments, including HM15275, which mirrors the weight loss effects of surgical procedures, and other drugs to improve weight loss quality and suppress the yo-yo effect.

"Obesity is a severe disease threatening human health, and there's a global recognition of its chronic nature requiring treatment," said Kim Na-young, managing director of Hanmi's new product development division. "Starting with the first GLP-1 obesity drug, we will strive to achieve groundbreaking results through the simultaneous development of drugs within the H.O.P Project."