A homegrown obesity drug will join South Korea’s market next month, where Wegovy and Mounjaro currently dominate. Hanmi Pharmaceutical’s Efe (ingredient: efpeglenatide) is a GLP-1 obesity treatment developed in-house. Attention is focused on whether it can differentiate itself from existing treatments with clinical data from Korean patients, its safety profile and domestic production.
According to industry sources on Sept. 10, Hanmi Pharmaceutical is in the final stages of preparations for Efe’s launch in South Korea as early as next month. Hanmi applied for approval from the Ministry of Food and Drug Safety in December last year, and the drug is undergoing review after being designated for the Global Innovative Product on Fast Track (GIFT) program.
Efe is a once-weekly GLP-1 receptor agonist developed using Hanmi Pharmaceutical’s proprietary LabDiscovery platform technology. If launched, it will become the first homegrown GLP-1 obesity treatment developed and manufactured by a South Korean pharmaceutical company using its own technology.
The biggest point of interest is its weight-loss efficacy. In a 40-week interim analysis of a Phase 3 trial involving 448 South Korean patients with obesity, the average weight-loss rate in the Efe group was 9.75%. A total of 79.42% of patients lost at least 5% of their body weight, while 49.46% lost at least 10% and 19.86% lost at least 15%. The maximum weight loss for an individual patient was 30%.
Mounjaro recorded a maximum average weight-loss rate of 20.9% at 72 weeks in global clinical trials, while Wegovy recorded an average weight-loss rate of 13.2% at 68 weeks in a trial involving Korean and Japanese patients. However, Efe’s results are interim findings at 40 weeks, and the treatment periods, patient populations and trial designs differ, making direct comparisons difficult.
Efe’s key differentiator is clinical data from Korean patients. A total of 448 Korean patients with obesity participated in the Phase 3 trial. In particular, women with a body mass index (BMI) below 30 kg/m² recorded an average weight-loss rate of 12.20%, higher than that of the overall treatment group. Hanmi Pharmaceutical plans to target a broad range of patients, from those with severe obesity to those who are overweight or have Class 1 obesity.
As nausea, vomiting and diarrhea are among the most common gastrointestinal side effects associated with GLP-1 treatments, safety is also a key competitive factor. Hanmi Pharmaceutical said its Efe trials confirmed a favorable gastrointestinal safety profile. However, no clinical trial has directly compared Efe with Wegovy or Mounjaro.
Efe also reduced the risk of major adverse cardiovascular events by 27% compared with placebo in a global clinical trial involving about 4,000 patients with Type 2 diabetes. The risk of composite kidney-related events was also reduced by 32%. Hanmi Pharmaceutical is also pursuing plans to expand Efe’s indications to diabetes treatment in the future.
Hanmi Pharmaceutical plans to manufacture Efe at its Pyeongtaek Bio Plant. With global GLP-1 treatments experiencing supply shortages and stockouts amid surging demand, the ability to manufacture and supply Efe domestically is also seen as an advantage.
However, the specific price has not yet been disclosed. Because obesity treatments are not covered by South Korea’s national health insurance, patients must pay the full cost of the medication, making price one of the factors that can determine whether treatment is continued. Attention is also focused on whether domestic production will allow Hanmi to secure price competitiveness.
With Efe joining the South Korean market already dominated by Wegovy and Mounjaro, patients will have a broader range of obesity treatment options. Attention will now turn to whether Efe can establish itself in the market by leveraging its clinical data from Korean patients, safety profile and supply stability.
