[Edaily Reporter NA EUN-KYUNG ] A new domestically developed drug has emerged to compete in the obesity treatment market, which is currently dominated by global pharmaceutical companies. With HanmiPharm’s efeglenatide receiving marketing authorization from the Ministry of Food and Drug Safety (MFDS), the development of new obesity drugs in Korea has reached a turning point, moving beyond research and clinical trials into actual market competition. This also demonstrates the company’s capability to independently bring new obesity drugs to market, going beyond simply being selected by global pharmaceutical companies.

The Ministry of Food and Drug Safety announced on the 7th that it had approved “Epeo Autoinjector 2, 4, 6, 8, and 10 milligrams” (active ingredient: efeglenatide) manufactured by HanmiPharm(128940). It is the 45th new drug developed in Korea and the first new obesity treatment in the glucagon-like peptide (GLP)-1 class.

From Development to Prescription… First Domestic GLP-1 Drug Enters the Market

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

GLP-1 is a type of incretin hormone secreted from the intestines after meals, which plays a role in blood glucose control and appetite suppression. Epe glilenatide incorporates HanmiPharm’s proprietary sustained-release platform, “Lapscovery.” It has been developed as a once-weekly obesity treatment.

With this approval, HanmiPharm has secured its own new drug to compete with global products such as Novo Nordisk’s Wegovy and Eli Lilly’s Mounjaro. As domestic companies pursue clinical trials and technology exports for obesity treatment candidates, Epe has entered a phase where its competitiveness will be evaluated through actual prescriptions and sales.

Product approval signifies that the drug has cleared the gateway to market entry. Following its launch, factors such as weight loss efficacy and safety, as well as price, supply stability, and prescribing accessibility, are expected to influence product selection. The prescribing and sales experience HanmiPharm accumulates in the domestic market could also serve as the foundation for the development and commercialization strategies of subsequent obesity treatments.

From Return by Sanofi to In-House Development and Approval

Epfeglenatide was originally a candidate compound undergoing global development as a diabetes treatment. HanmiPharm licensed the technology for epfeglenatide to Sanofi in 2015 but had the rights returned in 2020. Since then, the company has continued in-house development and expanded clinical trials to include domestic obesity patients. This approval is significant in that the return of the rights from a global partner did not lead to the termination of development, but rather resulted in a domestically developed new obesity drug.

Along with commercializing the obesity treatment, HanmiPharm is also proceeding with development to expand its indications to include diabetes. Last May, the company began dosing in a domestic Phase 3 clinical trial evaluating the combination of efeglenatide with metformin and dapagliflozin in patients with Type 2 diabetes whose blood glucose levels are not adequately controlled by those medications alone. However, the indication approved this time is for obese and overweight adults who do not have diabetes.

Along with the commercialization of Epe, HanmiPharm is also developing a follow-up new drug to compensate for muscle loss during the weight loss process. Choi In-young, Head of the R&D Center (Vice President) at HanmiPharm, said in a recent interview with E-Daily, “Existing obesity treatments work by inducing a feeling of fullness to reduce food intake, which can lead to muscle loss,” adding, “HM17321, for which we licensed the technology to Genentech, is differentiated in that it compensates for this by promoting fat-centered weight loss.”

The Ministry of Food and Drug Safety (MFDS) conducted the approval review for Epe in accordance with the “Procedures for New Drug Product Approval and Review” guidelines established last year. It formed a dedicated 19-member product review team, including review specialists, and examined compliance with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) standards. The MFDS explained that it completed the review while maintaining communication with the company through tailored in-person meetings following the submission of the approval application.

The MFDS stated, “We will continue to enhance the predictability, transparency, and speed of our approval and review processes to ensure that treatments with sufficiently verified safety and efficacy can be made available promptly.”