The domestic new drug “Epe,” a glucagon-like peptide-1 (GLP-1) class therapy, is entering the obesity treatment market that has been dominated by Wegovy and Mounjaro. Attention is focusing on whether the arrival of this third entrant will reignite competition in obesity drugs. As the entry of Mounjaro previously led to a 40% reduction in the price of Wegovy’s lowest (starting) dose, there is also interest in whether Epe will trigger further price changes in obesity medications.

According to the pharmaceutical industry on the 16th, Hanmi Pharmaceutical is in the final stages of procedures with the goal of obtaining marketing authorization for Epe from the Ministry of Food and Drug Safety (MFDS) in October. After applying for marketing authorization in December last year, the company has been supplementing and submitting the data requested by the MFDS. If approval is granted in October, Hanmi is preparing to launch the product within one month, with a plan for an official market launch within this year. Epe has been designated by the MFDS as a candidate for Global Innovative product Fast Track (GIFT) review.

The marketing authorization review for a new drug proceeds through back-and-forth submission of supplementary data between the MFDS and the pharmaceutical company, allowing the company to gauge the review status to some extent. Jung Yoon-taek, head of the Pharmaceutical Industry Strategy Research Institute, said, “Judging from the fact that Hanmi is targeting October for approval, it is highly likely that the review has progressed considerably without any serious additional supplementation issues.”

The key question in the market is “At what price will Epe be launched?” Currently, the ex-factory price for a four-week supply of the starting dose is KRW 216,000 for Wegovy 0.25 mg and KRW 278,000 for Mounjaro 2.5 mg. Within the pharmaceutical industry, there is speculation that, as a latecomer, Epe could be priced in the KRW 100,000 range for a four-week supply.

Hanmi Pharmaceutical is withholding specific comments, stating that “no price has been decided yet,” but industry observers believe that securing price competitiveness will be essential for Epe to break through the “two-strong” structure formed by Wegovy and Mounjaro, which have extensive global clinical trial and prescription experience. A mid-level manager with more than 10 years of experience in the pharmaceutical sector said, “Hanmi has a very strong sales network targeting neighborhood clinics and small hospitals, to a degree that foreign pharmaceutical firms find difficult to match,” adding, “If it also secures price competitiveness, it will be able to rapidly expand its market share, especially among private clinics.”

The earlier launch of Mounjaro significantly drove down Wegovy’s price. Ahead of the launch of Mounjaro in August last year, Novo Nordisk cut Wegovy’s ex-factory price by approximately 10–40% depending on the dose. The starting dose price was reduced from KRW 372,000 to KRW 216,000, a decline of more than 40%. In response to the entry of a latecomer, the first mover countered with price cuts. This is why there is strong interest in what price tag Epe will carry when it comes to market.

Hanmi Pharmaceutical is also highlighting clinical data on Korean patients as one of Epe’s strengths. In a Phase 3 clinical trial involving 448 domestic obesity patients, subjects showed an average weight reduction rate of 9.75% after 40 weeks of treatment.

There are projections that the obesity treatment market itself could expand once Epe joins. This is because individuals who previously did not consider obesity medication due to cost burdens may newly enter the market. Lee Seung-kyu, vice chairman of the Korea Biotechnology Industry Organization, said, “If it is launched in the KRW 100,000 range, that would be nearly half the price of current products, making it an attractive option for people who have been unable to receive treatment due to cost,” adding, “As new demand emerges, the market itself could grow.”

Following Epe, domestic pharmaceutical companies seeking to enter the market are also accelerating obesity drug development. HK inno.N has completed enrollment of 313 patients for a domestic Phase 3 clinical trial of “EcnoGLP-1” (Ecnoglutide), a once-weekly GLP-1 class drug, and is aiming to complete dosing within this year. JW Pharmaceutical also filed for a domestic Phase 3 clinical trial last month for “Bopanglutide,” a GLP-1 class drug administered once every two weeks. Daewoong Pharmaceutical, Ildong Pharmaceutical, and Dong-A ST are also developing obesity treatments.

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