Hanmi Pharmaceutical's first domestically developed glucagon-like peptide-1 (GLP-1) obesity treatment, 'Epe' (ingredient name: epeglunatide), is expected to be available in the domestic market by the end of this month. The supply price for a four-week supply at the lowest dosage is projected to be in the high 100,000 won range. If priced lower than Wegovy and Munjaro, the domestic obesity treatment market could shift from a two-player dynamic to a three-way competition.
On October 7, the Ministry of Food and Drug Safety approved the marketing of 'Epe,' making it the 45th new drug developed in South Korea and the first GLP-1 obesity treatment produced domestically. Epe is a once-weekly injection used as an adjunct to a low-calorie diet and exercise for weight management in adults with obesity or overweight who do not have diabetes.
Market attention is focused on the pricing of 'Epe.' Industry sources indicate that the supply price for a four-week supply at the lowest dosage of 2 mg is being discussed in the high 100,000 won range.
Currently, the supply prices for the lowest dosages are approximately 216,000 won for Wegovy at 0.25 mg and about 278,000 won for Munjaro at 2.5 mg. If Epe is launched at a lower price than existing products, pricing could become a key competitive factor in the non-reimbursed obesity treatment market.
An industry insider noted, "Hanmi Pharmaceutical is reportedly deliberating on the pricing of Epe and is expected to emphasize its price advantage compared to competing products Wegovy and Munjaro."
Currently, the domestic obesity treatment market is largely dominated by Eli Lilly's Munjaro and Novo Nordisk's Wegovy. According to market research firm IQVIA, Munjaro's sales in the first half of this year reached 744.3 billion won, while Wegovy's sales totaled 217 billion won. Combined, these two products accounted for about 86% of the domestic obesity treatment market last year.
Epe's pricing competitiveness is seen as a potential game-changer in the market. There is a precedent for Novo Nordisk lowering the supply price of Wegovy before the launch of Munjaro.
Additionally, Epe's clinical competitiveness is bolstered by data obtained from Korean participants. In a Phase 3 clinical trial involving 448 adult patients with obesity in South Korea, Epe was administered for 40 weeks, resulting in an average weight loss of 9.75% from baseline. The average weight loss rate, including dropouts, was 9.02%, while the placebo group experienced a weight loss rate of 0.89%.
Among the treatment group, 49.4% lost more than 10% of their weight, and the average weight loss rate for female patients with a BMI under 30 was 12.2%. The total duration of the clinical trial was 64 weeks, and the weight loss effect observed at 40 weeks tended to be maintained afterward. However, the extent of additional weight loss after 40 weeks has not been disclosed.
Epe's average weight loss rate is lower than the key clinical results for Wegovy and Munjaro. Wegovy showed an average weight loss rate of 14.9% after 68 weeks, while Munjaro demonstrated a 20.9% average weight loss rate after 72 weeks. However, experts caution that direct comparisons are difficult due to differences in trial duration, patient populations, dosages, and evaluation methods.
Epe is expected to differentiate itself through tolerability and supply stability. In the Phase 3 trial, the incidence of nausea was 16.6%, and vomiting was 11.6%, both lower than Wegovy's rates of 43.9% for nausea and 24.5% for vomiting. The rate of discontinuation due to gastrointestinal adverse reactions was also lower for Epe at 1.2%, compared to Wegovy's 4.3%.
The stability of supply due to domestic production is also considered a strength. Unlike Wegovy and Munjaro, which are manufactured overseas, Epe is produced at Hanmi Pharmaceutical's bio plant in Pyeongtaek, Gyeonggi Province. This facility has the capacity to produce up to 20 million pre-filled syringes annually.
Hanmi Pharmaceutical plans to reduce the typical three-month launch preparation period to less than a month, aiming to supply Epe to the market by the end of this month. Kim Na-young, Vice President of Hanmi Pharmaceutical, stated, "It is significant that we can provide a treatment based on clinical evidence tailored to the characteristics of Koreans. We will ensure thorough quality control and a reasonable pricing system."
* This article has been translated by AI.
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