[Edaily Reporter Kim Hyung-il ] HanmiPharm(128940)is set to enter the domestic market ahead of the launch of Epe, an obesity treatment it developed in-house. In a market already dominated by Wegovy and Mounjaro, the company is expected to leverage its price competitiveness to attract new patients. HK inno.N Corporation(195940)is currently conducting clinical trials on follow-up candidate compounds, while global pharmaceutical company Eli Lilly is expanding its competitive scope through the development of oral treatments and next-generation drugs.

According to the securities industry on the 17th, HanmiPharm received marketing approval from the Ministry of Food and Drug Safety on the 7th for Epe glinatide (Epe), a glucagon-like peptide-1 (GLP-1) class obesity treatment. The company is targeting a launch by the end of this month. The supply price for the first four weeks is reported to be 129,800 won, including value-added tax. Korea Investment & Securities analyzed that the initial treatment cost for Epe is 37% lower than that of Wegovy.

Epe is entering the obesity treatment market by leveraging its price competitiveness. HanmiPharm confirmed an average weight loss of 9.75% in a domestic Phase 3 clinical trial involving 448 participants treated for 40 weeks. Korea Investment & Securities estimated Epe’s sales for next year at 128.7 billion won. The company plans to increase patient access by lowering the initial treatment cost and grow sales by expanding prescriptions. As the dosage increases, the supply price for a 4-week supply rises to 228,800 won for the 6 mg dose, 277,200 won for the 8 mg dose, and 299,200 won for the 10 mg dose. Consequently, whether its initial price competitiveness translates into actual prescription growth and long-term treatment demand will determine the success of its commercialization.

HanmiPharm’s short-term earnings are a cause for concern. Korea Investment & Securities estimated third-quarter revenue at 374 billion won and operating profit at 37.5 billion won. While revenue is expected to increase by 3% year-over-year, operating profit is projected to decline by 32%. Reflecting factors such as the poor performance of Beijing Hanmi, the firm lowered its target price by 10% to 730,000 won but maintained its “Buy” rating. The deferral of revenue recognition for technology royalties related to Genentech from the third quarter to the fourth quarter also impacted the operating profit outlook. The commercial success of Epe and the development of follow-on new drugs are cited as key variables for future earnings recovery.

HanmiPharm’s follow-on pipeline is also worth noting. Eposepegtrutide is a triple-action candidate that simultaneously targets GLP-1, GIP, and glucagon receptors. The company is expanding its development scope beyond obesity treatment to include metabolic-associated steatohepatitis (MASH). The company has completed a U.S. Phase 2b clinical trial and is currently analyzing the data; the possibility of additional technology transfers depending on the clinical results is also a point of interest. While Epe is expected to drive short-term sales, these follow-on candidates will be key indicators of HanmiPharm’s medium- to long-term growth potential.

Competition among latecomers in development is also intensifying. HK inno.N Corporation is conducting a Phase 3 clinical trial in Korea for Eknoglutide, a GLP-1 receptor agonist candidate for the treatment of obesity. Its Chinese partner, Saiwind Biosciences, announced results from a Phase 1b clinical trial targeting obese adolescents. At Week 20, the weight of the ecnoglutide treatment group decreased by 10.4–12.1% compared to baseline. The company appears to be expanding its research scope to include adolescent indications, following the development of obesity treatments for adults. Domestic clinical results and the future approval timeline are expected to determine its competitiveness as a latecomer.

Global pharmaceutical company Eli Lilly is competing in the domestic market with Mounjaro while simultaneously advancing the development of the oral obesity treatment Foundayo and the next-generation candidate Retatruotide. Oral treatments could offer a new option for patients who find injectable medications burdensome. Retatrutide is also a candidate drug that targets multiple receptors and could influence the competitive landscape of the next-generation obesity treatment market depending on future clinical results. With Novo Nordisk’s Wegovy also entering the fray, competition in the obesity drug market is expanding beyond price to include weight loss efficacy, side effects, and ease of administration.

Woo Hae-joo, an analyst at Korea Investment & Securities, stated, “Epe is priced 37% lower than Wegovy for the initial treatment cost and 17% lower for maintenance therapy, thereby improving accessibility,” adding, “With the initial monthly treatment cost set at around 129,000 won, this is expected to have a positive impact on expanding early market penetration.” He continued, “The cost-effectiveness and the perceived severity of side effects will influence sales,” adding, “The triple-action agent eposepegtrutide is currently in the data analysis phase following the completion of the U.S. MASH Phase 2b clinical trial, so attention should also be paid to the results and the potential for technology transfer.”