Hanmi Pharma’s Phase 3 trials for anti-obesity medicine approved

South Korea’s Hanmi Pharmaceutical Co. on Monday said the Ministry of Food and Drug Safety approved Phase 3 clinical trials for the company’s exclusive efpeglenatide, a glucagon-like peptide 1 (GLP-1) receptor agonist candidate for treating obesity and diabetes. 

Efpeglenatide is a GLP-1 medication to be taken once a week using Hanmi’s own platform technology Lapscovery.

A member of the GLP-1 receptor agonist class of medications, efpeglenatide acts as a GLP-1 hormone’s analog to stimulate insulin secretion and appetite suppression in the body. Major Phase 3 clinical trials done worldwide after the medicine was out-licensed in 2015 by the France-based global pharmaceutical giant Sanofi verified the drug’s effectiveness in weight loss and control of blood sugar level.

Efpeglenatide also slashes the incidence of major cardiovascular and kidney diseases, and academic journals worldwide including the prestigious New England Journal of Medicine published the results of the candidate drug’s trials.

Hanmi Pharmaceutical will pursue clinical development of efpeglenatide for commercial application in South Korea within three years.

The recent launch of the Hanmi Obesity Pipeline Project seeks to find full-period methods for the treatment, management and prevention of obesity. The development of efpeglenatide is this venture’s first commercialization model.

In addition, the project includes LA-GLP/GIP/GCG (HM15275), whose verified effectiveness is comparable to the weight loss effect of about 25% from surgical therapy, and a new bio drug for enhancing the quality of weight loss and suppressing yo-yo dieting by preventing muscle mass loss that could occur when using GLP-1 drugs.

Also featured are medicine for eating disorders, oral anti-obesity drugs, and digital treatment for obesity prevention and management.

Write to Ji-Hyun Lee at bluesky@hankyung.com