Hanmi Pharmaceutical wins approval for homegrown obesity drug 'Epe'; target price raised to 650,000 won

[Financial News] Expectations for Hanmi Pharmaceutical's obesity-treatment business are growing as, following domestic approval of its independently developed obesity drug efpeglenatide, the company also steps up development of next-generation obesity drugs using its proprietary artificial intelligence (AI) platform. iM Securities raised its target price for Hanmi Pharmaceutical from 600,000 won to 650,000 won, reflecting the value of a next-generation candidate that has entered clinical development.
On the 8th, iM Securities maintained its Buy rating on Hanmi Pharmaceutical and raised its target price to 650,000 won.
Hanmi Pharmaceutical's independently developed GLP-1-class obesity drug efpeglenatide (development code HM11260C) received approval from the Ministry of Food and Drug Safety on the 7th. It was approved as Epe Auto-Injector Injection in 2-, 4-, 6-, 8- and 10-mg strengths, making it Korea's 45th homegrown new drug.
It is an injectable treatment for chronic weight management in adults with obesity or overweight who do not have diabetes, used as an adjunct to a reduced-calorie diet and exercise.
Like Wegovy, it works on GLP-1 receptors to suppress appetite and increase feelings of fullness. Another distinguishing feature is that it is a long-acting formulation using Hanmi Pharmaceutical's proprietary platform technology, LAPSCOVERY.
As Wegovy from Novo Nordisk and Mounjaro from Eli Lilly compete in South Korea's obesity-treatment market, efpeglenatide from Hanmi Pharmaceutical is set to join them, expanding competition in the domestic market into a three-way contest.
However, clinical trials have shown weight-loss effects below those of Wegovy and Mounjaro, making price, data on Korean patients, side effects and supply competitiveness key factors expected to determine future market share.
Hanmi Pharmaceutical's obesity portfolio is not limited to commercializing existing products. Its next-generation obesity drug candidate HM17321, designed using its proprietary AI platform HARP-pSARo, is also currently in Phase 1 clinical trials.
Jung Jae-won, an analyst at iM Securities, said, "Beginning with the launch of its first obesity drug in the second half of this year, commercialization of existing products and development of next-generation drugs will proceed in parallel, potentially strengthening its business competitiveness in obesity and metabolic diseases."
He said, "No additional adverse events were identified in the Phase 1 trial of HM17321, and if positive news also emerges from clinical trials of MASH candidates being conducted by MSD, this could act as a catalyst for the stock price to rise."

[email protected] Kang Jung-mo Reporter