Hanmi Pharm "Obesity Treatment Drug Epeglenatide Phase 3 Approved by MFDS"

"Clinical Trials Underway with Goal of Commercialization Within 3 Years"

Hanmi Pharmaceutical announced on the 23rd that it has received approval from the Ministry of Food and Drug Safety to conduct Phase 3 clinical trials for 'Epeglenatide,' which has been developed as a metabolic disease treatment, as a treatment for obesity.

Epeglenatide is a once-weekly injectable metabolic disease treatment that activates glucagon-like peptide-1 (GLP-1), which increases the body's energy metabolism.

Hanmi Pharmaceutical licensed Epeglenatide to the multinational pharmaceutical company Sanofi in 2015, but in 2020, Sanofi returned the rights after changing its management strategy.

However, in the following year, 2021, Sanofi presented research results at the American Diabetes Association (ADA) showing that Epeglenatide is effective in controlling blood sugar and reducing body weight.

After concluding that this substance could be developed as a treatment suitable for the obesity standards of Koreans, Hanmi Pharmaceutical submitted a Phase 3 clinical trial plan to the Ministry of Food and Drug Safety in July.

Hanmi Pharmaceutical explained that Epeglenatide will be produced at the state-of-the-art biopharmaceutical dedicated factory, 'Pyeongtaek Smart Plant,' and unlike imported obesity treatments experiencing shortages, it can be supplied stably.