Hanmi Pharm to develop obesity drug customized for S.Korean

South Korea's Hanmi Pharmaceutical Co. plans to develop the GLP-1 class "Epeglenatide," which it received as a technology return from Sanofi S.A., into a personalized obesity drug for domestic.

This decision is based on the assessment that there is a market potential for developing a therapeutic agent targeting domestic obese patients with a body mass index (BMI) of 25 or higher.

With global companies launching successive GLP-1 drugs and experiencing soaring prices and scarcity, it is expected that expanding the domestic GLP-1 market will be profitable.

Hanmi Pharm announced Monday that it had submitted on July 28 an investigational new drug (IND) application for clinical phase 3 of the obesity drug Epeglenatide to the Ministry of Food and Drug Safety.

The company has been developing Epeglenatide, applying the Long Acting Protein/Peptide Discovery (LAPSCOVERY) technology, as a metabolic disorder treatment administered once a week. If it receives regulatory approval as an obesity drug, it plans to expedite commercialization.

Epeglenatide was a substance whose development rights were transferred to the French pharmaceutical company Sanofi in 2015 in a mega-contract worth up to 5 trillion won ($3.9 billion). However, Sanofi returned the development rights to Hanmi Pharm in June 2020.

This decision was made because the market potential weakened due to delays in Epeglenatide's development and the release of similar GLP-1 therapies such as Novo Nordisk's Saxenda and Ozempic.

After the agreement with Hanmi Pharm, Sanofi conducted five global phase 3 clinical trials involving about 6,000 metabolic disorder patients. In June 2021, the French drug maker presented the clinical results orally at the American Diabetes Association (ADA) and published the research results in The New England Journal of Medicine. Hanmi Pharm's explanation was that this confirmed the drug's potential.

According to the South Korean company, Epeglenatide was proven to reduce the risk of major cardiovascular and renal events in a large-scale cardiovascular outcome trial (CVOT) involving over 4,000 patients.

Considering these circumstances, Hanmi Pharmaceutical concluded that Epeglenatide could be optimized for Koreans with obesity standards (BMI 25kg/m2) as a "Korean-customized GLP-1." While global companies are introducing GLP-1 obesity drugs one after another, most of them are tailored for severely obese patients in Western countries.

"It means developing the first GLP-1 obesity drug developed by a Korean pharmaceutical company through independent technology, as a 'Korean-customized obesity drug' that reflects the physique and weight of Koreans," a company source said.

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