Korea approves Hanmi's homegrown obesity shot after a trial showing 9% weight loss in 40 weeks
Korea's regulator approved Hanmi Pharmaceutical's efpeglenatide, the first homegrown GLP-1 obesity drug, after patients lost 9.02% of body weight in 40 weeks. That is less than Wegovy and Mounjaro showed in longer trials, so Hanmi's case rests on milder side effects and a price for long-term patients that it has not yet set.
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What happened
- The weekly shot is cleared for non-diabetic adults with a BMI of 30 or more, or 27 to 30 with a weight-related condition such as high blood pressure.
- Its final Phase 3 trial enrolled 448 Koreans averaging 43 years old, 89 kilograms and a BMI of 32.
- In that trial 75.1% of patients on the drug lost at least 5% of their body weight, against 13.5% on placebo.
- Hanmi licensed the molecule to Sanofi in 2015 for diabetes, got the rights back in 2020 and redeveloped it for obesity in Korean trials.
- Hanmi expects to start supplying the drug as early as the end of this month.
Why it matters
- Who has to decide decision Hanmi has to set a launch price before showing whether weight loss kept building after week 40, and that answer governs how close to Wegovy's price it can credibly go.
- What's now possible capability Production at a Korean plant gives prescribers a GLP-1 supply outside the import channel where Wegovy and Mounjaro have run short.
- What it limits constraint Because the efficacy comparisons rest on separate trials of different length, patients and design, Hanmi has to compete on tolerability and price.
Next story · Invest · 2d ago
Hanmi's Eppe discount to Mounjaro shrinks from 53% at the starting dose to 19% at maintenanceConfirmed3 publishers
Next to the rivals' published results, Hanmi's 40-week figure is about 60% of the 14.9% that semaglutide, Wegovy's ingredient, produced over 68 weeks. It is about 43% of the 20.9% tirzepatide reached at its top dose over 72 weeks [4][12]. For the trial's average patient, efpeglenatide's result works out to roughly 8 kilograms lost, against about 13 and 19 at the rivals' rates [13]. On that crude ratio, a course of efpeglenatide matches a course of Wegovy on cost per point of weight lost only if it costs about 60% as much [12].
The ratio ignores time. Hanmi's reading came 28 weeks before semaglutide's endpoint and 32 weeks before tirzepatide's [16]. Spread evenly across each trial, efpeglenatide's loss is about 0.23 points a week, against 0.22 for semaglutide and 0.29 for tirzepatide [14]. On that measure Hanmi could charge about 3% more per week than Wegovy and still match it per point lost [14]. That holds only if the loss kept accruing at the same pace after week 40.
The trial ran 64 weeks. According to JoongAng Daily, the loss seen at week 40 tended to persist through week 64, and the week-64 average was not disclosed [11]. If the 9.02% simply held, the weekly rate over the full trial falls to about 0.14 points, and the break-even drops to about 64% of Wegovy's weekly price [15]. The 64-week case is also the closer match in length to the 68-week semaglutide trial. Between the two readings, Hanmi's price ceiling against Wegovy moves by about 39 percentage points [17]. Hanmi has the week-64 figure that decides between them and has not released it [11].
Tolerability is what Hanmi offers for any price near the top of that range. Diarrhea hit 17.6% of patients, nausea 16.6% and vomiting 11.6% [10]. JoongAng Daily says those rates were lower than Wegovy's and generally at or below Mounjaro's [20]. The report does not give the rivals' rates, so the size of that gap cannot be checked from it.
"The price has not yet been finalized, but we plan to set it at a level that can ease the burden on patients who require long-term treatment and lower the barrier to accessing obesity drugs," a Hanmi spokesperson said [3]. Where that price lands sets up three outcomes. Below about 64% of Wegovy's, the drug holds up on cost per point even if weight loss stalled after week 40 [15]. Near import prices, patients would be paying for fewer side effects alone. And if imported supply tightens again, availability could decide prescriptions before price does [7].
I think Hanmi is pricing for maintenance, the patient who stays on a weekly shot for years, and the spokesperson's wording points the same way [3]. The counter-case is the week-64 number: if patients had regained weight by then, the long-term pitch fails [11]. A launch price above about 64% of Wegovy's, with no week-64 figure published, would prove this view wrong. Hanmi would then be charging for a tolerability edge the published comparison cannot size [15][20].
What to watch
- Hanmi's launch price as a share of Wegovy's weekly cost, against a break-even between roughly 64% and 103% depending on the week-64 result.
- Publication of the trial's week-64 average weight loss, and whether it sits above or below the 9.02% seen at week 40.
- Whether imported Wegovy or Mounjaro supply tightens in Korea after the launch.
Information, not investment advice. This story is general information about companies and markets, drawn from cited reporting. It is not a recommendation to buy, sell or hold any security; check the cited sources before acting.
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- [1]
The Ministry of Food and Drug Safety approved Hanmi Pharmaceutical's Eppe Auto Injector, active ingredient efpeglenatide, as the 45th new drug developed in Korea; it is Korea's first domestically developed GLP-1 obesity drug.
- [2]
Hanmi's drug is expected to reach the market as early as the end of this month.
- [3]
"The price has not yet been finalized, but we plan to set it at a level that can ease the burden on patients who require long-term treatment and lower the barrier to accessing obesity drugs."
- [4]
Semaglutide, Wegovy's active ingredient, produced average weight loss of 14.9% in a 68-week trial; tirzepatide, Mounjaro's active ingredient, produced up to 20.9% depending on dose in a 72-week trial.
- [5]
According to JoongAng Daily, efficacy cannot be determined from those figures alone because the trials differed in duration, participants and design.
- [6]
Hanmi developed efpeglenatide itself, licensed it to Sanofi in 2015 for global development as a diabetes treatment, resumed development after Sanofi returned the rights in 2020, and shifted it to obesity with clinical trials in Korea.
- [7]
Hanmi plans to make efpeglenatide at a domestic plant, seen as an advantage for supply stability with less risk of the shortages experienced with Wegovy and Mounjaro.
- [8]
The weekly injection is approved, alongside diet and exercise, for chronic weight management in non-diabetic adults with a BMI of 30 or higher, or a BMI of at least 27 but under 30 with at least one weight-related condition such as high blood pressure, dyslipidemia, sleep apnea or cardiovascular disease.
- [9]
The final Phase 3 trial enrolled 448 Koreans with an average age of 43, average weight of 89 kilograms and average BMI of 32.
- [10]
Side effects in the efpeglenatide trial were mainly gastrointestinal: diarrhea 17.6%, nausea 16.6%, indigestion 15.6%, constipation 14.6% and vomiting 11.6%.
- [11]
The full trial lasted 64 weeks; weight loss observed through week 40 tended to persist through week 64, but the final average weight loss at week 64 was not disclosed.
- [12]
Efpeglenatide's 40-week weight loss is about 60% of semaglutide's 68-week figure and about 43% of tirzepatide's top-dose 72-week figure; on endpoint figures alone, matching Wegovy on cost per point lost requires a course costing about 60% as much.
- [13]
For an 89 kg patient, efpeglenatide's 40-week result is roughly 8 kg lost, against about 13 kg and 19 kg at semaglutide's and tirzepatide's published rates.
- [14]
Spread evenly over each trial, weight loss is about 0.23 points a week for efpeglenatide, 0.22 for semaglutide and 0.29 for tirzepatide; on that basis efpeglenatide's break-even weekly price is about 103% of Wegovy's.
- [15]
If efpeglenatide's 9.02% loss held flat to week 64, its weekly rate over the full trial is about 0.14 points, and its break-even weekly price falls to about 64% of Wegovy's.
- [16]
Hanmi's 40-week reading came 28 weeks before semaglutide's 68-week endpoint and 32 weeks before tirzepatide's 72-week endpoint.
- [17]
The break-even weekly price against Wegovy ranges from about 103% (40-week pace) to about 64% (loss flat to week 64), a spread of about 39 percentage points.
- [18]
After 40 weeks of treatment, patients on efpeglenatide lost an average 9.02% of initial body weight, versus 0.89% for placebo.
- [19]
75.1% of efpeglenatide patients lost at least 5% of their body weight, versus 13.5% in the placebo group.
- [20]
Those side-effect rates were lower than with Wegovy and generally lower than or similar to those of Mounjaro, according to JoongAng Daily.
Sources
2 independent publishers whose own reporting we read for this story.
- en.sedaily.comKorea Approves First Homegrown GLP-1 Obesity Drug
4 articles · October 9, 2026
- koreajoongangdaily.comKorea's first GLP-1 obesity drug wins approval with less weight loss but fewer side effects
1 article · October 7, 2026
Topics and entities
Topics
- GLP-1 and obesity pharmacotherapy
- Drug pricing
- Drug approval in South Korea