Korea's First Domestic GLP-1 Obesity Drug Nears Launch, With Prices Set to Rise After First Month

A cheaper start, followed by a higher treatment bill

South Korea's first domestically developed GLP-1 obesity medicine could reach patients by late October 2026, with an estimated introductory wholesale cost of 129,800 won for four weeks. Hanmi Pharmaceutical's Epe, also rendered as Eppe, received Ministry of Food and Drug Safety approval on October 7. Its active ingredient is efpeglenatide.

The opening price is attracting attention because it is below the roughly 210,000 won quoted for Wegovy and 270,000 won for the lowest dose of Mounjaro over four weeks. Yet Epe's reported pricing schedule contains another important figure: four weeks at its eventual maintenance dose would cost 299,200 won at the wholesale level.

Patients therefore face two separate cost questions: how much it takes to begin treatment, and how much it takes to continue. Hanmi has not officially confirmed the reported dose prices, and the amount patients pay will vary by medical institution and prescribing arrangements.

The launch also comes as Novo Nordisk seeks national health insurance coverage for Wegovy. A successful application could lower eligible patients' personal expenses, changing a market in which imported medicines have dominated prescriptions.

Epe brings a different package of evidence and infrastructure: a trial involving 448 Korean adults, average weight loss of 9.75% after 40 weeks, and planned production of both its active ingredient and finished injections in Pyeongtaek. Its commercial prospects will depend on how those features work together with price, side effects and access to treatment.

What exactly has Korea approved?

The Ministry of Food and Drug Safety approved efpeglenatide injections in five strengths: 2, 4, 6, 8 and 10 milligrams. The approved product, Epeo Auto Injector, is intended for chronic weight management in adults with obesity or overweight who do not have diabetes, alongside a diet with fewer calories and exercise.

Epe became South Korea's 45th domestically developed new drug. Earlier expectations had placed it at number 44, before the approval announcement established its position.

The ministry reviewed the application under its New Drug Product Approval and Review Procedures guideline, introduced in 2025. A dedicated team of 19 people assessed clinical trial standards and manufacturing quality, and the regulator held tailored meetings with Hanmi during the review.

Approval gives Hanmi permission to market the medicine for the specified use. The company said it was working to supply Epe as early as the end of October, moving from regulatory clearance to production and distribution.

From a diabetes project to an obesity launch

Efpeglenatide's development stretches back more than a decade. Hanmi licensed it to Sanofi in 2015 as a potential diabetes treatment. The rights returned to Hanmi in 2020, after which the company pursued its own obesity development programme.

Hanmi's December 2025 announcement records the exact application date and the earlier fast review designation. It also describes a broader plan to develop diabetes uses, different injection devices and treatment combined with digital medical tools.

• 2015: Hanmi licensed efpeglenatide to Sanofi for diabetes development.
• 2020: The rights returned to Hanmi.
• October 2025: Hanmi released interim results after 40 weeks from its Korean obesity trial.
• November 27, 2025: Efpeglenatide received designation under the ministry's Global Innovative Products on Fast Track programme, known as GIFT.
• December 17, 2025: Hanmi completed its Korean marketing approval application.
• October 7, 2026: The ministry approved the obesity treatment.
• Late October 2026: Hanmi aims to begin market supply.

GIFT provides shorter review periods and tailored regulatory support for qualifying innovative medicines. Hanmi submitted its approval application 20 days after receiving that designation.

How a weekly injection helps people feel full

Efpeglenatide acts on receptors for GLP-1, a hormone released in the digestive system after eating. A receptor is a receiving point on a cell: when the medicine activates it, the body responds to a signal similar to the natural hormone's message.

GLP-1 helps stimulate insulin release, slows the movement of food out of the stomach and sends signals associated with fullness. Those effects can reduce appetite and help people eat less.

Natural GLP-1 is broken down within minutes by an enzyme called DPP-4. Hanmi uses its LAPSCOVERY technology to extend efpeglenatide's action in the body, allowing an injection once a week.

Wegovy's ingredient, semaglutide, also acts on GLP-1 receptors. Mounjaro's ingredient, tirzepatide, acts on both GLP-1 and another hormone pathway called GIP. These differences in design are part of the competition, alongside the weight loss measured in clinical trials.

What the Korean trial found

Hanmi's phase 3 obesity trial involved 448 Korean adults. Phase 3 studies are a major stage of testing used to assess a treatment's effectiveness and safety before a marketing decision. The interim results after 40 weeks showed average weight loss of 9.75% among participants receiving efpeglenatide.

The results also describe how many treated participants reached different levels of weight loss. A total of 79.42% lost at least 5% of their starting weight, 49.46% lost at least 10%, and 19.86% lost at least 15%. The greatest individual reduction reported was 30%.

The average and the largest individual reduction tell different parts of the story. The 9.75% figure describes the average result in the treatment group, while the 30% figure describes the highest reported individual result. Patients experienced a range of responses.

Professor Kim Sung-rae, an endocrinologist at the Catholic University of Korea's Bucheon St. Mary's Hospital and principal investigator of the domestic trial, described weight loss of around 10% as clinically meaningful for Korean patients. He also pointed to differences between the Korean participants and those enrolled in trials of imported drugs.

How Epe compares with Wegovy and Mounjaro

Wegovy produced average weight loss of 14.9% over 68 weeks in a global phase 3 trial. Mounjaro's reported average was 20.9% over 72 weeks. Epe's figure was 9.75% over 40 weeks.

The imported medicines were studied for 28 and 32 weeks longer, respectively. Professor Kim also noted that participants in their trials generally had an average body mass index of around 38, compared with approximately 32 in the Korean efpeglenatide trial.

Body mass index, or BMI, relates a person's weight to their height. The difference between those starting averages means the trial groups entered treatment with different degrees of obesity, alongside differences in study duration and design.

A comparison within the same study, using similar participants and the same follow-up period, would give a more useful measure of the medicines' relative effects. For patients and prescribers considering Epe at launch, its Korean trial supplies evidence from a population closer to the people expected to use it locally.

The full dose schedule changes the price picture

Industry pricing details published on October 14 put Epe's wholesale cost per injection at 24,200 won for 2 milligrams, 40,700 won for 4 milligrams, 57,200 won for 6 milligrams, 69,300 won for 8 milligrams and 74,800 won for 10 milligrams. Hanmi said wholesale charges differ from patients' prescription costs and had not officially confirmed those figures.

The reported schedule starts low and gradually increases the dose. The resulting four-week wholesale costs are:

• Weeks 1 to 4: Two injections of 2 milligrams and two of 4 milligrams, costing 129,800 won.
• Weeks 5 to 8: Four injections of 6 milligrams, costing 228,800 won.
• Weeks 9 to 12: Four injections of 8 milligrams, costing 277,200 won.
• From week 13: Four injections at the maintenance dose of 10 milligrams, costing 299,200 won per four weeks.

At those prices, the first four weeks cost 80,200 won less than Wegovy's quoted 210,000 won and 140,200 won less than Mounjaro's quoted 270,000 won. Epe's maintenance supply costs about 2.3 times its introductory supply, calculated from 299,200 won divided by 129,800 won.

The first 12 weeks would total 635,800 won in wholesale medicine costs. That calculation gives a fuller view of the starting treatment period than the opening price alone.

Epe's maintenance price also exceeds the cited introductory prices of its rivals. Comparing continuing treatment expenses requires the prices of the doses each patient actually receives, as well as consultation and dispensing charges.

A Hanmi Pharmaceutical representative explained the payment arrangements:

Eppe is a prescription drug that is not covered by national health insurance. The amount patients pay may vary depending on medical consultations and prescribing conditions.

Wegovy's insurance application could reshape access

Novo Nordisk Korea has submitted a reimbursement application for Wegovy to the Health Insurance Review and Assessment Service, or HIRA. The company says it is seeking broader treatment access for patients with severe obesity and accompanying conditions such as cardiovascular disease.

HIRA's Pharmaceutical Reimbursement Evaluation Committee reviews whether a medicine should receive coverage. Drug price negotiations with the National Health Insurance Service follow as part of the reimbursement process.

Insurance would shift part of the treatment bill from eligible patients to the national insurance system. The final coverage criteria, patient payments and decision date have not been announced.

If coverage focuses on severe obesity and associated illness, different groups of patients could face very different costs. People eligible for insured Wegovy could pay less personally, while those outside the criteria would continue comparing treatments largely through their own budgets.

Novo Nordisk previously reduced Wegovy's price in August 2025 as Mounjaro entered the Korean market. Its reimbursement application adds another route to improving affordability, although broader coverage would also create spending commitments for national health insurance.

Side effects and evidence beyond weight loss

Nausea, vomiting and diarrhoea were reported in Epe's obesity trial at levels described as manageable. Hanmi plans gradual dose increases at intervals of two and four weeks to help patients tolerate treatment, particularly during the early stages.

Hanmi says its formulation technology and dosing approach are intended to reduce fluctuations in medicine exposure and improve gastrointestinal tolerability. Direct comparative trials assessing tolerability against competing medicines are still lacking.

Efpeglenatide also has earlier evidence from the AMPLITUDE-O trial in people with type 2 diabetes. The study was described as enrolling approximately 6,000 people and reported a 27% reduction in the relative risk of major cardiovascular events, together with a reduction of more than 30% in kidney disease progression.

A relative risk reduction describes how much lower a risk was compared with the study's comparison group. It differs from the percentage of all participants who avoided an event, which depends on how often that event occurred in each group.

The diabetes findings belong to a different patient population from Epe's approved obesity use in adults without diabetes. Hanmi is pursuing a separate phase 3 programme combining efpeglenatide with an SGLT-2 inhibitor and metformin, two types of diabetes medicine, with a target of diabetes approval in 2028.

Domestic production and a wider development strategy

Hanmi plans to manufacture both efpeglenatide's active ingredient and the finished medicine at its Pyeongtaek Bio Plant in Gyeonggi Province. Domestic production gives the company direct responsibility for supply in a market that has experienced shortages of imported obesity treatments.

Kim Na-young, Hanmi's executive vice president and head of its Innovative Growth Division, described the approval's value for Korean patients:

The approval of efpeglenatide is particularly meaningful because it enables us to provide a stable supply of an obesity treatment supported by clinical evidence reflecting the characteristics of Korean patients, in a market that has long relied on imported medicines.

Hanmi also brings an established prescribing network. It ranked first among South Korean pharmaceutical companies in outpatient prescription sales for eight consecutive years from 2018 to 2025.

LG Chem's diabetes medicine Zemiglo provides a local commercial precedent. Launched in 2012 into a market with established imported competitors, it later expanded through clinical evidence, combination products and joint marketing with Daewoong Pharmaceutical. It ranked first in outpatient prescription sales among DPP-4 inhibitors in 2023.

Hanmi's plans extend beyond the current injector. Its December 2025 announcement proposed syringes already filled with medicine, pens containing multiple doses and packages of health supplements and medicines sold without a prescription. The company also set a target of applying in the first quarter of 2026 for permission to test a treatment combining efpeglenatide with digital medical devices.

A digital lifestyle platform called TLS is being developed to monitor diet, physical activity and sleep. Hanmi's stated aims include supporting continued treatment and addressing weight regain and muscle loss.

A separate candidate, HM17321, is being developed to reduce fat while preserving muscle. Its phase 1 trial is underway following clearance of its US investigational application in November 2025. Hanmi licensed the candidate to Genentech in a deal with a $190 million upfront payment and potential payments of up to $2.3 billion, including development milestones.

Hanmi retains Korean rights and would receive royalties after commercialization. Genentech is set to take over development from phase 2 and handle manufacturing and commercialization outside Korea. Investor interest in that candidate and Epe has prompted higher brokerage price targets, including increases from 680,000 won to 720,000 won at DS Securities and from 500,000 won to 610,000 won at Samsung Securities.

Key Points

• Epe received Korean approval on October 7, 2026, with supply targeted for late October.
• The weekly injection is approved for weight management alongside diet and exercise in adults with obesity or overweight who do not have diabetes.
• Its Korean trial reported average weight loss of 9.75% after 40 weeks.
• The estimated wholesale cost rises from 129,800 won for the first four weeks to 299,200 won for four maintenance doses. Hanmi has not officially confirmed the figures.
• Epe is not covered by national health insurance, and patient bills will vary.
• Wegovy's pending insurance application could change treatment costs for eligible patients.
• Hanmi plans domestic production in Pyeongtaek and is targeting a separate diabetes approval in 2028.