Hanmi Pharmaceutical won South Korean approval for Eppe on Oct. 7, advancing its effort to turn a returned diabetes candidate into an obesity treatment for patients in its home market.
The Ministry of Food and Drug Safety (MFDS) cleared five strengths: 2, 4, 6, 8 and 10 milligrams. Under the approved use, Eppe is for eligible adults who do not have diabetes; care also includes limiting calorie intake and exercising. Hanmi says Eppe is the first GLP-1 obesity drug developed by a South Korean company.
Label data from a Korean phase 3 trial involving 448 adults put the adjusted mean weight change at −9.02% for patients given efpeglenatide after 40 weeks, compared with −0.89% for those given placebo. The label also says 75.05% of efpeglenatide recipients lost at least 5% of body weight, compared with 13.53% in the placebo group. The study compared Eppe with placebo, not with other obesity drugs.
Hanmi credits Group Vice Chair Lim Ju-hyun with deciding to redevelop efpeglenatide for obesity. Hanmi formed a group on April 13 to coordinate development, manufacturing, distribution and marketing. Hanmi plans to produce the drug at its Pyeongtaek facility and says it wants the starting price to make treatment easier to begin.
Efpeglenatide originated as a diabetes candidate and was one of three treatments covered by Hanmi and Sanofi’s 2015 licensing agreement. Sanofi’s announcement put the portfolio deal’s upfront payment at €400 million, with eligibility for up to €3.5 billion in milestone payments across the three candidates. Those milestones were contingent payments, not money already received for Eppe. Hanmi later said it regained efpeglenatide’s rights in 2020 after Sanofi changed its research strategy.
Hanmi began its obesity-pipeline program in 2023 and identifies Eppe as its lead asset. The company has not announced a firm launch date or the final price patients will pay.
