As the launch of South Korea's first obesity drug, Hanmi Pharmaceutical's 'Epe' (epiglenatide), approaches, attention is turning to the strategies of domestic competitors. If Epe competes with the established weekly injections of Wegovy and Manjaro, other local companies are opting for differentiated dosing schedules, formulations, and mechanisms of action to carve out niche markets.
According to industry sources, the Ministry of Food and Drug Safety approved Hanmi Pharmaceutical's GLP-1 (glucagon-like peptide-1) obesity treatment 'Epe' as the 45th new drug developed in South Korea on October 7. Hanmi plans to launch the product as early as the end of this month. The emergence of the first domestic GLP-1 obesity treatment is expected to accelerate the development competition among latecomers.
The most advanced competitor is HK inno.N. Its 'Eknoglutide,' introduced from China's Saiwind Biosciences in 2024, is notable for being the world's first cAMP (cyclic adenosine monophosphate) biased GLP-1 receptor agonist, enhancing signaling selectivity. In China, it received approval for obesity indications in March this year, following its approval as a diabetes treatment. Clinical trials for obesity and diabetes treatments are currently underway in South Korea.
Competition is also heating up for long-acting injectable formulations with extended dosing intervals. JW Pharmaceutical secured exclusive development and commercialization rights in South Korea for 'Bofanglutide' from China's Gan & Lee in April. This GLP-1 receptor agonist is administered every two weeks. In a Chinese phase 3 trial, participants receiving 48 mg showed an 18.54% weight reduction after 52 weeks.
In August, JW Pharmaceutical submitted plans for domestic phase 3 clinical trials for obesity and type 2 diabetes indications to the Ministry of Food and Drug Safety. The obesity trial is set to begin in December. By extending the dosing interval from weekly to biweekly, the annual injection frequency would decrease from 52 to 26.
Dongkook Pharmaceutical is developing a long-acting obesity treatment candidate, 'DKF-MB501,' which is designed to maintain efficacy for over three months with a single dose. Currently in the formulation and preclinical research stage, it aims to enter phase 1 clinical trials next year.
The competition is also intensifying for non-injection formulations. Daewoong Pharmaceutical and Daewoong Therapeutics are developing 'DWRX5003,' a patch that delivers semaglutide via microneedles applied to the skin. They have received approval for phase 1 clinical trials, with the first participant registration completed in May.
Il Dong Pharmaceutical continues to work on an oral obesity treatment. 'ID110521156,' taken once daily, showed an average weight loss of 9.9% and a maximum of 13.8% after four weeks in a phase 1 trial involving 36 healthy adults.
Market analysts note that pricing and insurance coverage will be critical factors for commercialization. According to a study published in the journal 'Obesity' by the American Obesity Society, 47.6% of 288 patients who discontinued treatment with semaglutide and tirzepatide cited cost and insurance issues as reasons for stopping.
Jung Jae-won, a researcher at iM Securities, stated, "Given that economic burden is a major reason for discontinuing obesity treatment, demonstrating competitive pricing could trigger an increase in market share. If Epe can also highlight its price advantages compared to existing obesity treatments, it is expected to secure a significant market share."
Meanwhile, the domestic obesity treatment market is rapidly expanding. The market, valued at 242.6 billion won in 2024, grew to 819.5 billion won last year, more than tripling in just one year. Currently, Wegovy and Manjaro dominate the market with approximately 86% share. With the anticipated entry of 'Epe' this year, the competitive landscape is likely to shift from a two-player to a three-player dynamic.
* This article has been translated by AI.
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