[Edaily Reporter Kim Jinsoo ] HanmiPharm(128940) The GLP-1 obesity treatment “Epe Autoinjector Injection” (hereinafter “Epe”) has received domestic approval, throwing down the gauntlet to Wegovy and Mounjaro. With clinical data from Korean patients and a domestic production base as its strengths, Epe’s key competitive factors will be price and supply stability. The extent to which it can reduce the financial burden on patients undergoing long-term treatment is expected to determine its success in the market.

Wegovy and Mounjaro boast high market share on the global stage and have accumulated extensive data. However, since these drugs have not yet undergone analysis of domestic prescribing patterns, analysts predict that Epe—which has secured clinical data specific to Koreans—will possess strong competitive advantages in the domestic market.

In a Phase 3 clinical trial involving 448 obese patients, Epe recorded an average weight loss rate of 9.75% over 40 weeks. Among the patients, 79.42% lost 5% or more of their body weight, 49.46% lost 10% or more, and 19.86% lost 15% or more. While it is difficult to directly compare different clinical trials, given that Wegovy and Mounjaro demonstrated weight loss effects in the mid-to-high 10% range and around 20%, respectively, in global trials, Epe is not significantly behind in terms of weight loss rates, and its additional benefits are expected to appeal to patients.

HanmiPharm highlights Epe’s strength as a strategy that provides Korean patients with an appropriate level of weight loss while reducing the burden of treatment. Epe’s Phase 3 clinical trial was conducted on 448 obese patients in Korea. The Phase 3 data, collected primarily from Korean patients, could be a competitive advantage in the domestic market.

A HanmiPharm official stated, “Since the clinical trial was conducted to reflect the characteristics of Korean obese patients, who have a relatively lower body mass index (BMI) than Western patients, there is sufficient evidence to support its use in actual domestic prescribing practices.”

Gastrointestinal adverse reactions—such as nausea and diarrhea—commonly associated with GLP-1 agonists were found to be manageable. Since obesity treatments are administered over the long term, their actual competitiveness depends not only on weight loss efficacy but also on how long patients can continue taking the medication without discontinuing treatment due to side effects.

Price is expected to be another strength of Epe. Epe is produced in-house at HanmiPharm’s Pyeongtaek Bio Plant. Since everything from development to production takes place domestically, it can be manufactured at a lower cost than imported products such as Wegovy and Mounjaro. Furthermore, as it is unaffected by exchange rates and overseas supply chain issues, it is expected to hold a competitive advantage in terms of price.

Since most obesity treatments are prescribed as non-covered services, the financial burden on patients is significant. If the launch price is set low enough, Epe could become a powerful weapon capable of surpassing Wegovy and Mounjaro. Domestic production is also significant in that it can minimize the supply shortages that have repeatedly occurred in the global GLP-1 market.

Epe is widely regarded as possessing significant competitiveness not only in Korea but also on the global stage. In the “AMPLITUDE-O” study, previously conducted by HanmiPharm on 4,076 patients with type 2 diabetes, Epe reduced the risk of major cardiovascular events by 27% and the risk of renal composite events by 32% compared to a placebo. Although this study did not target obese patients, it is expected to serve as clinical evidence that can be utilized in the process of expanding the drug’s indications to the fields of diabetes and metabolic diseases in the future.

Kim Na-young, Executive Vice President and Head of the Innovation and Growth Division at HanmiPharm, stated, “We are reviewing pricing not merely in terms of low-cost competition, but with the goal of reducing the number of patients who forgo or discontinue necessary treatment due to financial burdens.” She added, “The final price will be determined after comprehensively reflecting market conditions and other factors. We plan to reduce the financial burden on patients requiring long-term treatment, thereby lowering the barriers to obesity treatment and improving access to care.”