Hanmi Pharmaceutical has entered the domestic obesity drug market with EPPE (Efpeglenatide), a 100% homegrown medication, challenging the long-standing duopoly of Wegovy and Mounjaro. EPPE aims to carve out its market share by leveraging clinical data from Korean subjects and domestic production capabilities.
On Thursday, industry sources reported that the Ministry of Food and Drug Safety had approved EPPE as an injectable supplement to low-calorie diets and exercise regimens for chronic weight management in overweight or obese adults without diabetes.
EPPE is a once-weekly GLP-1 class obesity treatment. GLP-1, a hormone released by the intestines after eating, regulates blood sugar and increases satiety. GLP-1 based therapies have become the cornerstone of the obesity treatment market due to their appetite-suppressing and weight-reducing effects.
Hanmi applied its proprietary LAPSCOVERY platform technology to EPPE, extending the drug’s duration in the body and allowing for less frequent dosing.
Previously, Hanmi and its former partner Sanofi conducted global clinical trials involving approximately 6,000 type 2 diabetes patients. After regaining the rights, Hanmi continued development based on accumulated clinical data, ultimately securing approval for EPPE as an obesity treatment.
This makes EPPE the first GLP-1 obesity drug entirely developed by a Korean pharmaceutical company, from candidate discovery through clinical development, approval, manufacturing, and commercialization.
Hanmi emphasizes EPPE’s strength in clinical evidence gathered exclusively from Korean subjects. The Phase 3 trial for domestic approval included only Korean participants. Interim top-line results from the 40-week Phase 3 trial, released last October, showed an average weight loss of 9.75% among 448 Korean obesity patients, with some individuals losing up to 30% of their body weight.
Of the participants, 79.42% lost more than 5% of their body weight, 49.46% lost over 10%, and 19.86% shed more than 15%.
Notably, EPPE demonstrated good tolerability regarding gastrointestinal side effects common to GLP-1 obesity treatments, such as nausea, vomiting, and diarrhea. Hanmi believes that gradually increasing the dosage at 2-week and 4-week intervals may help mitigate these issues.
EPPE is manufactured entirely at Hanmi’s Pyeongtaek Bio Plant, from raw material production to final product manufacturing. The company claims this approach ensures a stable domestic supply, addressing concerns about reliance on imported pharmaceuticals.
Hanmi also touts price competitiveness as a key market entry strategy. They plan to offer the initial dosage of EPPE at a reasonable price to lower barriers for patients beginning obesity treatment.
Furthermore, Hanmi is pioneering the development of digital fusion medicine, combining digital medical devices with pharmaceuticals – a first for a Korean drug company. This initiative aims to position EPPE as a comprehensive obesity management solution rather than just a weight loss treatment.
Through their Total Lifestyle Care (TLS) platform, Hanmi plans to support patients in improving exercise performance, diet, and lifestyle habits post-treatment, promoting healthy weight loss and enhancing long-term treatment adherence.
