Efpeglenatide approval makes Hanmi the first Korean maker of a GLP 1 obesity drug

South Korea's drug regulator has cleared Hanmi Pharmaceutical's weekly GLP 1 injection for chronic weight management, and the efpeglenatide approval makes it the first obesity drug of its class developed by a Korean company. The Ministry of Food and Drug Safety announced the decision on Wednesday 7 October, according to Korean newspapers, and Hanmi says supply could start as early as the end of October. The molecule moves from filed to approved on our board. Its trial weight loss is smaller than that of the market leaders, so the case rests on tolerability, local data and supply.

What the Korean regulator approved

The approval covers adults without diabetes who have a body mass index of 30 or more, or who are overweight with a body mass index from 27 to under 30 and at least one weight related condition. Those conditions include high blood pressure, abnormal blood fats, sleep apnoea and cardiovascular disease. The drug is a once weekly injection given from an auto injector, meant to be used alongside diet and exercise. Korean outlets report that it is the 45th new drug developed in the country to win approval. The Korea JoongAng Daily report describes it as the first GLP 1 obesity treatment developed by a domestic company.

Efpeglenatide has a long history. Hanmi first developed it and licensed it to Sanofi in 2015 as a diabetes treatment. Sanofi handed the rights back in 2020, and Hanmi then shifted the programme towards obesity and ran its own trials in Korea. During the Sanofi years, a global cardiovascular outcomes trial of roughly 4,000 people reported fewer major heart events and signs of kidney protection, according to the Herald Corporation business daily. That trial was in people with diabetes, not in the obesity population now on the label. Hanmi also plans to manufacture the drug at its own plant in Pyeongtaek, which Korean coverage presents as a supply advantage over imported rivals.

The Korean phase 3 behind the efpeglenatide approval

The efpeglenatide approval rests on a phase 3 trial in 448 Korean adults with an average age of 43, an average weight of 89 kilograms and an average body mass index of 32. The study ran for 64 weeks in total. At week 40, people on the drug had lost 9.02 percent of their starting weight against 0.89 percent on placebo, as reported by the Korea JoongAng Daily. Weight loss seen by week 40 tended to hold through week 64, but the final average at week 64 has not been disclosed. Herald Corporation, citing an interim analysis, reported a week 40 figure of 9.75 percent, so the exact number depends on which analysis is quoted.

At week 40, people on the drug had lost 9.02 percent of their starting weight against 0.89 percent on placebo, as reported by the Korea JoongAng Daily.

Gastrointestinal effects were the most common side effects, as with other drugs in the class. The table lists the reported rates in the efpeglenatide group; placebo rates and the share of people who stopped treatment were not given in the coverage we could check. A full peer reviewed paper would settle these gaps. The Korea JoongAng Daily notes that side effect rates were lower than those reported for semaglutide and broadly similar to or lower than those for tirzepatide. That comparison crosses separate trials with different designs and populations, so it is a pointer, not a finding. The trial was also run only in Korea, which suits the local label but limits how far the numbers travel.

How it compares with Wegovy and Mounjaro

On weight loss alone, efpeglenatide sits below the two drugs that lead the Korean market. Korean coverage points to an average of 14.9 percent for semaglutide in a 68 week trial and up to 20.9 percent for tirzepatide in a 72 week trial, depending on the dose. Those trials ran longer, in different populations, and the reporters themselves note that the numbers cannot be compared directly. Still, the gap is wide enough that Hanmi is unlikely to compete on efficacy. The company's pitch, as reported, leans on tolerability, a trial run in Korean patients and a domestic supply chain, which Korean coverage presents as more stable than relying on imported drugs.

The approval also fits a wider pattern of national regulators clearing locally developed incretin drugs before Western ones reach them. Our story on how China approved mazdutide describes a similar step for Innovent's dual agonist. Unlike mazdutide, efpeglenatide is a single GLP 1 agonist, so it competes on access rather than on a new mechanism. Whether it gains a share of the Korean market will depend on uptake data that do not exist yet. Both cases show that a peptide can win its first approval in its home market well before any filing in the United States or Europe, which is why our board records national decisions as moves in their own right.

What Hanmi plans next

Hanmi is pursuing a diabetes label in a separate phase 3 programme that combines efpeglenatide with an SGLT2 inhibitor and metformin, with approval targeted for 2028, Herald reported. It is also developing prefilled syringe and multi pen versions and a form linked to digital therapeutics. Behind efpeglenatide sit two next generation candidates, HM15275, a triple agonist, and HM17321, which Hanmi is developing for weight loss with muscle preservation. Neither has reached a late stage trial, so neither appears on our board yet. The near term checkpoint is simpler: the first supply of the drug to Korean clinics, which the company said could come at the end of October.

For readers following the class, the approval adds a new name to the approved column of our pipeline board. It joins semaglutide, tirzepatide, mazdutide and the oral agents among incretin drugs with at least one approval somewhere in the world. Full week 64 results and a peer reviewed paper are the pieces still missing. Until they appear, the efficacy picture rests on week 40 figures reported in the press, and two outlets give slightly different numbers. All incretin molecules we follow, with their stage and latest move, sit on our incretins class page, where efpeglenatide now has its own entry and its next checkpoint listed.

Conclusion

The efpeglenatide approval gives South Korea its first locally developed GLP 1 obesity drug, cleared on a 448 person domestic trial that showed about 9 percent weight loss at week 40. That is less than the market leaders achieve in longer trials, and full week 64 data are still unpublished. The next checkpoints are the planned end of October launch and a peer reviewed trial report. This story is research news, not medical advice.