Ministry of Food and Drug Safety grants marketing approval on the 7th... Commercialization of the first GLP-1 obesity treatment developed by a domestic pharmaceutical company

The South Korean GLP-1 obesity treatment market is bracing for a shake-up as Hanmi Pharmaceutical’s homegrown new drug, "Epe," enters the arena. With the commercialization of the first domestically developed GLP-1 treatment in a market previously dominated by Wegovy and Mounjaro, the competitive landscape is set to undergo significant changes.

On the 7th, Hanmi Pharmaceutical announced that it has received marketing approval from the Ministry of Food and Drug Safety (MFDS) for "Epe" (generic name: efpeglenatide), a GLP-1 receptor agonist obesity drug.

Epe is the first GLP-1 obesity drug for which a domestic pharmaceutical company has independently carried out the entire process—from candidate substance discovery and clinical development to approval, manufacturing, and commercialization. It applies Hanmi’s proprietary platform technology, "LAPSCOVERY."

Previously, efpeglenatide underwent global clinical trials with partner company Sanofi involving approximately 6,000 type 2 diabetes patients. Following the return of its rights, Hanmi continued its independent development as an obesity treatment based on accumulated clinical data, ultimately entering the domestic commercialization stage with this approval.

Domestic clinical trials verified its efficacy and safety specifically targeting Korean patients.

According to interim topline results from a 40-week Phase 3 clinical trial released last October, 448 Korean obesity patients treated with Epe showed an average weight loss of 9.75%, with individual patients achieving up to 30% weight loss.

Patients who experienced weight loss of 5% or more accounted for 79.42% of the treatment group, while those with a 10% or greater reduction stood at 49.46%, and those with a 15% or greater reduction were recorded at 19.86%. Hanmi explained that the drug demonstrated favorable tolerability regarding common gastrointestinal adverse events associated with GLP-1 class treatments, such as nausea, vomiting, and diarrhea.

Notably, Hanmi presented two key differentiating factors for Epe: clinical data based entirely on 100% Korean participants and a step-by-step dose escalation regimen spanning 2+4 week intervals. This strategy gradually increases the dosage to lower the risk of gastrointestinal side effects.

The company also differentiated Epe from existing imported products in terms of production and supply. Epe will be manufactured entirely in-house, from raw material synthesis to finished product manufacturing, at Hanmi Pharmaceutical’s Pyeongtaek Bio Plant. This strategy aims to reduce supply uncertainties caused by reliance on imported pharmaceuticals and build a stable domestic supply chain.

Price competitiveness will also be a variable shaping future market settlement. Hanmi plans to lower the barrier to entry for medical staff and patients by applying a reasonable pricing structure based on initial dosages. As specific market pricing and prescription environments take shape, competition with existing imported GLP-1 treatments is expected to intensify.

Leveraging Epe, Hanmi is also pursuing the development of digital convergence pharmaceuticals that combine drugs with digital medical devices. Through the "TLS (Total Lifestyle care) platform," which supports improved athletic performance and better dietary and lifestyle habits post-administration, the company envisions building an integrated treatment platform that manages not only weight loss but also long-term treatment compliance.

Industry insiders view Epe's approval as going beyond the mere addition of a single obesity drug; it signifies the first time a homegrown novel drug is entering active competition in a domestic GLP-1 market previously driven by global pharmaceutical giants. However, experts note that to successfully compete with global products that have already secured a first-mover advantage, Epe will be comprehensively evaluated on its long-term safety, real-world treatment persistence rates, price, and supply stability. Particularly in the domestic obesity treatment market, which is centered on non-reimbursable (out-of-pocket) spending, price competitiveness is widely analyzed as a major variable determining actual prescription expansion.

As the GLP-1 treatment market—currently led by imported pharmaceuticals from global drugmakers—grows to approximately 2 trillion won, Hanmi Pharmaceutical aims to expand its new drug competitiveness in the metabolic disease sector and strengthen its domestic production foundation through the commercialization of Epe.

Kim Na-young, Vice President of Hanmi Pharmaceutical’s Innovation Growth Division, stated, "This product approval for Epe is highly significant because it allows us to stably supply a treatment tailored to the characteristics of Koreans, backed by clinical evidence, moving away from our past reliance on overseas imported drugs. To ensure successful market settlement, we will contribute to improving patients' quality of life through rigorous quality control and a reasonable pricing system."

[ⓒ Global Economic Times. 무단전재-재배포 금지]