Hanmi’s P3T for ’Korean GLP-1 obesity drug’ is approved

Optimized for Koreans

MFDS approves Phase III trial for ‘efpeglenatide’ in Korea

Clinical development to start at full scale at the end of the month… to commercialize the drug within 3 years

The development of an ‘GLP-1 obesity treatment optimized for Koreans' is gaining momentum.

 

Hanmi Pharmaceutical announced on the 23rd that the Ministry of Food and Drug Safety approved the Phase III clinical trial for its ‘efpeglenatide,’ a glucagon-like peptide 1 (GLP-1) receptor agonist developed by the company.

 

Epeglenatide is a GLP-1 receptor agonist that acts as a GLP-1 hormone analogue that helps secrete insulin and suppress appetite in the body.

 

After being licensed out to the global pharmaceutical company Sanofi in 2015, its efficacy in weight loss and blood sugar control was confirmed through a large-scale global Phase III clinical trial.

 

In addition, it significantly reduced the incidence of major cardiovascular and kidney diseases, and the results were published in a number of academic journals including the world-renowned New England Journal of Medicine (NEJM).

 

As the innovativeness of efpeglenatide has been confirmed through large-scale global clinical trials, Hanmi Pharmaceutical plans to conduct clinical trials to commercialize the drug in Korea within 3 years.

 

Efpeglenatide will be produced at Hanmi Pharmaceutical's state-of-the-art biopharmaceutical plant, 'Pyeongtaek Smart Plant'.

 

This is because the domestic production of the drug will ensure stable supply at an economical cost, greatly increasing the accessibility and sustainability of drugs for obese patients in Korea.

 

Hanmi Pharmaceutical recently launched the 'H.O.P Project’ that seeks a treatment approach that encompasses the whole cycle of obesity, from its treatment, and management, to prevention.

 

The company seeks to accelerate the development of efpeglenatide as the first commercial model.

 

Na-young Kim, Senior Managing Director at Hanmi Pharmaceutical (Head of new product development), said “Starting with the first new GLP-1 obesity drug developed solely by a Korean pharmaceutical company with its proprietary technology, we strive to bring innovative results through the simultaneous development of drugs through H.O.P.

 

project.”