Hanmi Pharmaceutical’s obesity drug candidate HM11260C (epiglenatide) achieved significant weight loss and a favorable safety profile in a South Korean Phase III trial, accelerating plans for commercialization in the second half of 2026.
At the same time, results from Hanmi’s MASH treatment licensed to Merck are expected early next year, further strengthening the company’s metabolic-disease portfolio.

On October 27, Hanmi Pharmaceutical announced topline Phase III results for HM11260C, its once-weekly GLP-1 receptor agonist.

In 448 obese adult participants without diabetes, 79.4% of patients receiving epiglenatide achieved > 5% body-weight reduction, compared with 14.5% in the placebo group—a 65-point difference after 40 weeks (p < 0.0001).

Average weight reduction reached 9.75% in the treatment group versus 0.95% for placebo (ANCOVA, p < 0.0001).

For reference, Novo Nordisk’s Wegovy (semaglutide) reported –13.2% mean weight loss (placebo –2.1%) over 68 weeks in 401 Asian participants. Despite a shorter trial period, Hanmi’s epiglenatide demonstrated comparable efficacy through the same mechanism of action.

The Phase III safety assessment found that gastrointestinal events—nausea (16.7%), vomiting (11.7%), and diarrhea (17.7%)—occurred less frequently than typically reported with other GLP-1 agents.

Although study design and duration differ across trials, epiglenatide appeared to cause fewer GI reactions than Wegovy (24% nausea, 26% diarrhea) or Mounjaro (31% nausea, 23% diarrhea).

However, whether epiglenatide can avoid the muscle loss often seen with GLP-1 therapies remains unclear. Muscle-mass data were not included in the announcement, though a Hanmi spokesperson highlighted “reduced gastrointestinal side effects as a key differentiator.”

Hanmi is also advancing next-generation obesity programs focused on simultaneous fat reduction and muscle preservation. These include the triple agonist HM15275 (target commercialization by 2030, FDA Phase II clearance in July) and the CRFR2-selective UCN2 analog HM17321 (IND filed for Phase I in September). Both will be featured at ObesityWeek 2025 in Atlanta this November.

Building on the Phase III success, Hanmi plans to file for marketing authorization this year and launch HM11260C in the second half of 2026. A 24-week extension study will follow the 40-week core treatment to assess weight-loss durability over 64 weeks.

Wegovy’s sales in Korea have already exceeded $140 million within six months of launch, and the South Korean obesity drug market is expected to reach $349 million this year. With manufacturing capacity secured and a nationwide distribution network established through its dyslipidemia drug Rosuzet, Hanmi is well-positioned to capture market share.

An industry expert remarked, “If Hanmi enters the market by late next year, it could quickly establish itself as a leading South Korean player.” Still, government scrutiny over misuse and overprescription is expected to shape reimbursement and regulatory policies for the category.

Hanmi is also advancing in the MASH (Metabolic Associated Steatohepatitis) space. Its candidate MK-6024 (epinofegtutide), licensed to Merck in 2020, is in the final stage of a Phase IIb trial.

Merck’s study enrolls 360 patients to compare epinofegtutide, semaglutide, and placebo arms, with completion expected in December and results due in Q1 2026. The primary endpoint is MASH resolution without fibrosis worsening at week 52.

As the FDA-approved Wegovy recorded 62.9% success for the same endpoint in Phase III, the upcoming Merck readout could draw renewed attention to Hanmi’s MASH platform technology.