Eppe now enters a three-way race against Novo Nordisk's Wegovy and Eli Lilly's Mounjaro, two imported drugs that have split the Korean market between them.
Hanmi said the domestic GLP-1 market has grown to about 2 trillion won ($1.49 billion), and most of that spending goes to global drugmakers. Shares however opened Thursday 6 percent lower at 502,000 won.
The drug, known chemically as efpeglenatide, cut body weight by an average of 9.75 percent over 40 weeks in a phase 3 trial of 448 Korean patients with obesity, according to interim results released last October.
Nearly half of patients shed 10 percent or more of their weight, and some lost as much as 30 percent.
The firm says it carried the drug through every stage itself, from discovery to manufacturing. It builds on data from global trials of about 6,000 type 2 diabetes patients run with Sanofi before the French drugmaker returned the rights.
Production runs from start to finish at Hanmi's bio plant in Pyeongtaek, south of Seoul.
"The approval carries great significance, as it allows us to provide a steady supply of a treatment based on clinical evidence tailored to Koreans, in a market that has long relied on imported drugs," said Kim Na-young, executive vice president and head of Hanmi's innovation growth division.
Hanmi said a stepwise increase in dosage lowers the risk of nausea, vomiting and diarrhea, side effects common to GLP-1 drugs, and that it will set a competitive price for the starting dose.
Eppe has not been tested head to head against Wegovy or Mounjaro.
AJP Takeaways
- Hanmi Pharmaceutical's Eppe (efpeglenatide) received marketing approval from South Korea's Ministry of Food and Drug Safety on Oct. 7, 2026, the first GLP-1 obesity drug developed by a Korean company.
- Eppe reduced body weight by an average of 9.75 percent over 40 weeks in a phase 3 trial of 448 Korean patients, according to interim results Hanmi released in October 2025.
- Eppe enters a Korean GLP-1 market of about 2 trillion won that Novo Nordisk's Wegovy and Eli Lilly's Mounjaro have dominated, and Hanmi makes the drug at its own plant in Pyeongtaek.
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