[Edaily Reporter Kim Jinsoo ] Epfeglenatide, developed by HanmiPharm, has received approval from the Ministry of Food and Drug Safety as the first domestically developed GLP-1-based obesity treatment. With this approval, Korea has laid the groundwork to compete in the global obesity treatment market—which is projected to grow to approximately 160 trillion won by 2030—by leveraging its own domestically developed new drug. Analysts say this marks a turning point where domestically developed obesity drugs have moved beyond the research and development stage and are now entering full-scale market competition.

On the 7th, the Ministry of Food and Drug Safety granted marketing authorization to HanmiPharm’s “Epe Autoinjector Injection 2, 4, 6, 8, 10 mg” (hereinafter “Epe”), the 45th domestically developed new drug.

Epe is an injectable medication administered as an adjunct to a low-calorie diet and exercise therapy for the chronic weight management of obese and overweight adults without diabetes. It is an obesity treatment that acts on GLP-1 receptors distributed throughout the central nervous system—including the hypothalamus and medulla oblongata—and the gastrointestinal tract to suppress appetite and delay gastric emptying, thereby sustaining a feeling of fullness.

GLP-1 is a type of incretin hormone secreted in the intestines after a meal; it plays a role in regulating blood sugar and suppressing appetite. Most obesity treatments currently dominating the global market are GLP-1-based medications.

The approval of HanmiPharm’s Epe is significant because it marks the first time a GLP-1-based obesity treatment developed independently by a domestic pharmaceutical company has entered the commercialization phase. While the domestic market has been effectively dominated by imported products such as Wegovy and Mounjaro, the launch of Epe has significantly increased the likelihood of intense competition in terms of price and supply. In particular, HanmiPharm has a vertically integrated system capable of handling everything from the raw material (epeglenatide) to final production, ensuring supply stability and cost competitiveness.

The global obesity treatment market is growing rapidly, driven by the widespread adoption of GLP-1 agonists; Goldman Sachs projects the market size to reach approximately $114 billion (152.59 trillion won) by 2030. Given that global GLP-1-based obesity treatments, such as Mounjaro, are solidifying their market positions with strong clinical and prescribing data as originator products, Epe is expected to demonstrate its competitiveness in terms of price, safety, clinical data specific to Koreans, and long-term treatment convenience.

A HanmiPharm spokesperson stated, “We plan to lower the barriers to entry for obesity treatment and increase access to care by offering a more affordable price, thereby reducing the financial burden on patients who require long-term treatment.”

Choi In-young, Vice President of HanmiPharm, emphasized, “Just as Eli Lilly, a late entrant, led a shift in the obesity drug landscape, HanmiPharm is preparing to be a game-changer with differentiated competitive advantages that big pharma lacks. We will succeed in the obesity drug market with our diverse pipeline.”