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Design logo for Hanmi Pharm's obesity treatment 'Eppe.' / Hanmi Pharm

The first homegrown novel drug has emerged in the domestic GLP-1 obesity treatment market, which had long been dominated by imported medications. This milestone follows the domestic product approval of Eppe, independently developed by Hanmi Pharm. As a therapeutic handled domestically from development to manufacturing enters the commercialization phase, competition in the obesity market is poised to broaden into a battlefield featuring domestic options.

The Ministry of Food and Drug Safety announced on the 7th that it approved Hanmi Pharm's Eppe Auto-Injector (ingredient: efpeglenatide) in 2, 4, 6, 8, and 10 mg dosages. It marks the first domestically developed GLP-1 class obesity therapy and South Korea's 45th novel drug. The drug received approval as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients who are obese or overweight without diabetes.

This approval holds significant weight, as it represents the first time a GLP-1 obesity therapeutic developed using homegrown proprietary technology has reached commercialization. Hanmi Pharm confirmed its weight loss efficacy through domestic clinical trials and established an in-house manufacturing framework at its Pyeongtaek Bio Plant. As a novel obesity therapy handled entirely in-house from development to production, the company aims to leverage this foundation to secure supply stability and price competitiveness.

Eppe was designed for once-weekly administration utilizing Hanmi Pharm's extended-release platform technology, LAPSCOVERY. It acts on GLP-1 receptors distributed across the central nervous system and the gastrointestinal tract to suppress appetite, while slowing gastric emptying to prolong satiety.

According to Hanmi Pharm, 40-week interim results from a domestic Phase 3 clinical trial involving 448 obese adults demonstrated an average weight reduction rate of 9.75% in the Eppe administration group. Among female patients with a body mass index (BMI) under 30 kg/m², an average weight reduction of 12.20% was observed. Significant improvements compared to the placebo cohort were also confirmed across metabolic indicators such as waist circumference, blood glucose, lipids, and blood pressure.

Efpeglenatide was initially developed as a type 2 diabetes drug candidate. It was licensed out to multinational pharmaceutical company Sanofi in 2015, but rights were returned in 2020 following changes in Sanofi's business strategy. Hanmi Pharm subsequently focused on its weight loss efficacy and continued developing it as an obesity treatment. This stands as a rare success story where a domestic firm persevered through a license return to successfully achieve domestic approval.

Following efpeglenatide's designation for Global Innovative Products on Fast Track (GIFT) review in November last year, Hanmi Pharm submitted its application for product approval in December of the same year. This year, the company has operated a cross-functional launch committee spanning R&D, clinical development, manufacturing, and distribution to achieve commercialization within the year.

Once Eppe is launched, market competition currently led by Wegovy and Mounjaro is expected to intensify further. According to reports citing IQVIA data, combined domestic sales of the two drugs reached 427.2 billion won in the first quarter of this year. Given that Wegovy previously lowered starting-dose pricing in response to Mounjaro's domestic launch, Eppe's launch price and countermeasures from established incumbents will likely serve as key determinants in the ensuing market rivalry.

                                                                                                              Bae Da-hyun