“The feeling of fullness lasts a long time” ... Hanmi’s obesity drug is Korea’s 45th homegrown novel drug

[Financial News] Hanmi Pharmaceutical’s independently developed GLP-1 obesity treatment efpeglenatide has been approved as Korea’s 45th homegrown novel drug.
The Ministry of Food and Drug Safety said it approved ‘Epeo Auto-Injector Injection 2, 4, 6, 8 and 10 mg (active ingredient: efpeglenatide; development code: HM11260C)’ on the 7th.
The drug is an injection administered as an adjunct to a reduced-calorie diet and exercise for chronic weight management in adults with obesity or overweight who do not have diabetes. It acts on GLP-1 (glucagon-like peptide-1) receptors distributed in the central nervous system, including the hypothalamus and medulla oblongata, and in the gastrointestinal tract, suppressing appetite and slowing the rate at which food leaves the stomach to prolong the feeling of fullness. GLP-1 is a type of incretin hormone secreted by the gut after meals and helps regulate blood sugar and suppress appetite.
The Ministry of Food and Drug Safety conducted the approval review under its ‘Procedures for the Marketing Authorization and Review of New Drugs’ guideline, established last year. It formed a dedicated product review team of 19 members, including specialist reviewers, and conducted reviews under both Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) standards. The ministry said that after the marketing authorization application was submitted, it held tailored in-person meetings, communicated closely with the company, and carried out a prompt and thorough review.
A ministry official said, "We will continue to improve the predictability, transparency and speed of our authorization and review processes so that we can quickly make available treatments whose safety and efficacy have been sufficiently confirmed." 
If efpeglenatide launches, South Korea’s obesity treatment market will become a three-way contest. The domestic market is currently dominated by foreign-made obesity treatments, including Wegovy from Novo Nordisk and Mounjaro from Eli Lilly and Company. Wegovy launched in South Korea in October 2024.
Its mechanism of action is the same as Wegovy’s. Wegovy is a single-receptor agonist that acts only on GLP-1 receptors, while Mounjaro is a dual agonist that acts simultaneously on both GLP-1 and GIP receptors. Like Wegovy, efpeglenatide is a GLP-1-only agonist and a long-acting formulation made using Hanmi Pharmaceutical’s proprietary platform technology, LAPSCOVERY.
By the numbers, its weight-loss effect is lower than those of the other two drugs. In a Phase 3 trial involving 448 Korean patients with obesity, the mean change in body weight at week 40 of treatment was -9.75%, compared with -0.95% in the placebo group. The net weight loss after accounting for the placebo effect was 8.80 percentage points—less than the 12.5 percentage points in Wegovy’s STEP 1 trial (68 weeks), the 11.1 percentage points in STEP 6, which involved Korean and Japanese participants (68 weeks), and the 17.8 percentage points for the 15 mg dose in Mounjaro’s SURMOUNT-1 trial (72 weeks). The proportions of patients who lost at least 10% of their weight were 49.46% for efpeglenatide, 69.1% for Wegovy and 84% for Mounjaro 15 mg.
However, there are limits to a direct comparison. The efpeglenatide results are from an interim analysis at week 40 of a 64-week trial, while the Wegovy and Mounjaro results cover 68 to 72 weeks. There has also been no head-to-head trial directly comparing all three drugs, making it difficult to determine which is superior based on the current data alone.
Hanmi Pharmaceutical cites Korean-specific data, side effects and price as the drug’s strengths. Among the subgroups analyzed, female participants with a BMI below 30 had the largest change in body weight, at -12.20%. The company also said gastrointestinal adverse events such as vomiting, nausea and diarrhea occurred at rates far below those previously reported.

Another point of differentiation is that the drug can be produced at the Pyeongtaek Smart Plant and supplied reliably at an economical cost. Industry observers also expect that Wegovy and Mounjaro are likely to cut prices after efpeglenatide launches in order to gain market share.

[email protected] Jung Myeong-jin, medical correspondent Reporter