MFDS approves Hanmi's EPPE, Korea's first homegrown GLP-1 obesity drug
In short
Korea's Ministry of Food and Drug Safety approved Hanmi Pharmaceutical's EPPE auto-injector (efpeglenatide) on Oct 7, the first domestically developed GLP-1 obesity drug and the country's 45th homegrown new drug. The injectable is indicated for chronic weight management in obese or overweight adults without diabetes, as an adjunct to a low-calorie diet and exercise. Yonhap reported the drug will join a market it says is divided between Novo Nordisk's Wegovy and Eli Lilly's Mounjaro, with Hanmi reportedly planning a launch within the year.
Read the full story 3 min read
Korea's Ministry of Food and Drug Safety approved Hanmi Pharmaceutical's EPPE auto-injector, whose active ingredient is efpeglenatide, on Oct 7, according to the company's home-market outlets and Yonhap. The approved doses are 2, 4, 6, 8 and 10 milligrams. Outlets reported it as the first GLP-1 obesity drug developed in Korea and the 45th domestically developed new drug approved in the country. [ 2 , 3 , 4 , 6 , 7 ]
The drug is an injectable for chronic weight management in obese or overweight adults who do not have diabetes, given as an adjunct to a low-calorie diet and exercise. According to the ministry's description carried by the outlets, it acts on GLP-1 receptors distributed in the central nervous system, including the hypothalamus and medulla, and in the gastrointestinal tract, suppressing appetite and slowing the emptying of food from the stomach so that feelings of fullness last longer. GLP-1 is described as a hormone released from the gut after eating that is involved in blood sugar control and appetite suppression. [ 2 , 3 , 4 , 6 , 9 ]
The ministry said it reviewed the product under the “new drug approval and review procedure” guideline it drew up last year, forming a 19-person dedicated product team that included review specialists and examining clinical trial and manufacturing and quality control standards, followed by tailored face-to-face meetings with Hanmi after the application. A ministry official said it would keep raising the predictability, transparency and speed of approval and review so that treatments with sufficiently confirmed safety and efficacy can be supplied quickly. [ 2 , 3 , 4 , 6 , 7 ]
Yonhap reported that EPPE will join a domestic GLP-1 obesity market it says is divided between Novo Nordisk's Wegovy and Eli Lilly's Mounjaro, and that competition is expected to intensify. It cited industry observers saying the drug will need price competitiveness to take hold early, and reported that EPPE is the flagship of Hanmi's obesity pipeline, H.O.P., with the company known to plan a launch within the year. [ 4 ]
Newsis, in a follow-up, said EPPE uses Hanmi's own LAPScovery platform and was developed as a “Korean-tailored” GLP-1 built around the Korean obesity threshold of a BMI of 25. It reported that in an interim top-line readout of a phase 3 trial in 448 Koreans, the mean weight change was -9.75%, with weight loss of up to 30%, and that rates of side effects such as vomiting and nausea were lower than for existing competing drugs. It also reported a -12.20% weight change among women with a BMI under 30, the largest reduction in that subgroup analysis. Those clinical figures appear in no other document here. [ 9 ]
Newsis also reported that the drug was out-licensed to the global pharmaceutical company Sanofi in 2015 and returned to Hanmi in 2020, and that Hanmi continued development. The outlet said the company is producing a documentary about the development journey covering its obesity and metabolic disease direction. Kim Na-young, the vice president responsible for EPPE's domestic development, was quoted as saying the drug carries the legacy of Hanmi's decades of new drug development and that the company plans to develop it beyond obesity treatment into a core option spanning metabolic diseases. [ 9 ]
Why it matters
The approval puts a domestically developed product into the Korean GLP-1 obesity market that Yonhap describes as split between Novo Nordisk's Wegovy and Eli Lilly's Mounjaro, which points to more competition. Yonhap cited industry observers saying price competitiveness will be needed for an early market foothold, and said Hanmi plans to launch within the year, which would give Korean patients a locally developed option. The documents give no approved price and, apart from one outlet's interim figures, no details of the pivotal trial results behind the approval.
Key facts
- The Ministry of Food and Drug Safety approved Hanmi Pharmaceutical's EPPE auto-injector, with the active ingredient efpeglenatide, in 2, 4, 6, 8 and 10 milligram doses. [ 2 , 3 , 4 , 6 , 7 ]
- It is the first GLP-1 obesity drug developed in Korea and the country's 45th domestically developed new drug. [ 2 , 3 , 4 , 5 , 6 , 7 , 9 ]
- The drug is an injectable for chronic weight management in obese or overweight adults who do not have diabetes, given alongside a low-calorie diet and exercise. [ 2 , 4 , 6 , 7 ]
- It works on GLP-1 receptors in the central nervous system and gastrointestinal tract to suppress appetite and slow the emptying of food from the stomach, prolonging fullness. [ 2 , 3 , 4 , 6 , 9 ]
- The ministry reviewed the product under its “new drug approval and review procedure” guideline drawn up last year, using a 19-person dedicated product team and reviewing clinical trial and manufacturing and quality control standards. [ 2 , 3 , 4 , 6 , 7 ]
- Yonhap reported the drug will enter a domestic GLP-1 obesity market it says is divided between Novo Nordisk's Wegovy and Eli Lilly's Mounjaro, and that Hanmi is known to plan a launch within the year. [ 4 ]
Confirmed by several sources
- The Ministry of Food and Drug Safety approved Hanmi Pharmaceutical's EPPE auto-injector (efpeglenatide) at 2, 4, 6, 8 and 10 milligram doses on Oct 7. [ 2 , 3 , 4 , 6 , 7 ]
- EPPE is the first GLP-1 obesity drug developed in Korea and the 45th domestically developed new drug. [ 2 , 3 , 4 , 5 , 6 , 7 , 9 ]
- The indication is chronic weight management in obese or overweight adults without diabetes, as an adjunct to a low-calorie diet and exercise. [ 2 , 4 , 6 , 7 ]
- The mechanism is action on GLP-1 receptors in the central nervous system and gastrointestinal tract, suppressing appetite and delaying gastric emptying. [ 2 , 3 , 4 , 6 , 9 ]
- The ministry reviewed the application under the “new drug approval and review procedure” guideline established last year, with a 19-person dedicated product team and reviews of clinical trial and manufacturing and quality control standards. [ 2 , 3 , 4 , 6 , 7 ]
Still unclear
- Reported efficacy: a mean weight change of -9.75% and weight loss of “up to 30%” in a phase 3 interim top-line analysis of 448 Koreans, with a -12.20% weight change in women with a BMI under 30. These figures appear only in the Newsis report, are attributed to Hanmi's interim top-line results rather than to the regulator, and the two headline figures are difficult to reconcile as reported.
- When the drug will actually go on sale in Korea and at what price. Yonhap says Hanmi is known to plan a launch within the year and that industry observers say price competitiveness will be needed, but no launch date or price is confirmed by the company or the ministry in the documents.
- The full pivotal trial data on which the approval rests. Outlets describe the review process and dosing but give no completed phase 3 results or primary endpoint; the only trial numbers cited are interim and come from a single outlet.
- Whether EPPE causes fewer side effects such as vomiting and nausea than competing drugs. This claim appears only in the Newsis report and is attributed to company information, not to the regulator.
What local media are saying
Timeline, local time
- Seoul Economic Daily reports the Ministry of Food and Drug Safety has approved Hanmi Pharmaceutical's EPPE auto-injector, the first domestically developed GLP-1 obesity drug and the country's 45th new drug. [ 2 ]
- Maeil Business reports the approval, including the 2 to 10 milligram dose range and the ministry's 19-person product team. [ 3 ]
- Yonhap reports the approval and notes the domestic GLP-1 obesity market is divided between Wegovy and Mounjaro, with industry expectations of price competition and a reported plan for a launch within the year. [ 4 ]
- Chosun Ilbo carries the approval, listing the five approved doses and the appetite-suppressing mechanism. [ 5 ]
- Hankook Ilbo reports the approval, describing EPPE as a Korean equivalent to Wegovy and Mounjaro and quoting a ministry official on speeding up approvals. [ 7 ]
- Newsis publishes a follow-up explaining the drug's Korean-tailored development, its phase 3 interim results and its history of being out-licensed to Sanofi and later returned. [ 9 ]