2026 is expected to be the year when Hanmi Pharmaceutical's corporate value is again judged by "clinical data." This year, Hanmi Pharmaceutical is set to disclose clinical results for key pipelines in obesity, metabolic dysfunction–associated steatohepatitis (MASH), and rare diseases.
As the ownership dispute within the founding family has effectively concluded, the new drug research and development achievements accumulated so far are now moving squarely onto the market's evaluation stage.
Hanmi Group faced its worst crisis since its founding amid a management control conflict among the owner family after founder Lim Sung-ki died. However, as the equity structure was settled early last year, much of the governance uncertainty was resolved.
Han Seung-yeon, an analyst at NH Investment & Securities, said, "If last year was the phase of expectations for new drugs, this year is the year of actual results disclosure." Jung Lee-su, an analyst at IBK Securities, also said, "This year, both the visibility of clinical results and the momentum for commercializing new drugs are in place, making it a time to watch closely."
◇ Obesity drug "Efpeglenatide," 64-week dosing results to be released in the first half… launch in the second half
The first pipeline to face market scrutiny is the obesity drug "Efpeglenatide." Hanmi Pharmaceutical plans to release clinical results on an additional 64 weeks of dosing in the first half of this year.
Efpeglenatide is a once-weekly injection based on GLP-1, a hormone that regulates weight. In the global market, Novo Nordisk's "Wegovy" and Eli Lilly and Company's "Mounjaro" are already commercialized. Hanmi Pharmaceutical is highlighting clinical data that reflect Asian body types and obesity characteristics as a strength.
Hanmi Pharmaceutical disclosed key phase 3 results in Oct. last year. In adults with obesity without diabetes who received the drug for 40 weeks, average body weight fell by about 8%, and more than 60% of all patients lost at least 5% of their weight. The company said the results showed a statistically significant difference versus placebo.
Based on these data, the company is proceeding with the domestic approval process and is aiming for a launch in the second half. Efpeglenatide is included in the Ministery of Food and Drug Safety's Global Innovative product Fast Track (GIFT), which could shorten the review timeline.
The variable is the global competitive landscape. With the substance patent for Novo Nordisk's semaglutide expiring in 2028, the possibility of generic launches thereafter has been raised. Some also say changes in the market environment will be inevitable if price competition intensifies.
The industry is focusing on the point that Efpeglenatide showed relatively low gastrointestinal (GI) side effects and that Hanmi Pharmaceutical has a vertically integrated structure from active pharmaceutical ingredients to manufacturing, distribution, and sales. Analysts say that in the domestic market, in addition to price competition, prescribing trust and supply stability could act as variables.
Kim Min-jung, an analyst at DS Investment & Securities, said, "Assuming the domestic obesity drug market is about 1.2 trillion won a year, Efpeglenatide could generate about 24.9 billion won in sales in the fourth quarter of this year."
◇ "MSD out-licensing" MASH therapy set to release phase 2b data… a gauge for development direction
The next pipeline drawing attention after the obesity drug is the MASH therapy "Epinepegdutide." This candidate completed a phase 2b trial late last year and is set to disclose results in the first half of this year.
Epinepegdutide is a drug that Hanmi Pharmaceutical out-licensed to Merck (MSD) in the United States in 2020 in a deal worth a total of $870 million. MSD holds the global development and sales rights excluding Korea, while Hanmi Pharmaceutical receives milestones and royalties by clinical stage.
In the previously disclosed phase 2a trial, it posted higher figures than competing drugs in reducing liver fat content (LFC). The liver fat in the Epinepegdutide-treated group fell an average of 72.7%, while the semaglutide group declined 42.3% over the same period.
However, because many patients with MASH also have diabetes, blood sugar control (HbA1c improvement) is also cited as a key endpoint. Some assess that Epinepegdutide has yet to show a clear advantage over competing drugs in this area. Novo Nordisk and Eli Lilly and Company are accumulating data demonstrating both liver fat reduction and blood sugar improvement.
Market caution grew recently when MSD did not mention Epinepegdutide separately at the JPM Healthcare Conference. The industry expects the phase 2b results to clarify whether it will enter phase 3 and the future development strategy.
◇ Rare disease pipelines at clinical inflection points as well… "Efeglucagon" awaiting phase 2b results
In rare diseases, the congenital hyperinsulinism treatment "Efeglucagon" has reached a clinical inflection point. Congenital hyperinsulinism is a disease in which excessive insulin secretion leads to recurrent hypoglycemia, occurring mainly in infants and children.
Hanmi Pharmaceutical is developing the therapy to manage the disease with a once-weekly injection and plans to release phase 2b results within the year. Efeglucagon has been designated an orphan drug in the United States, Europe, and Korea, and it also obtained the U.S. Food and Drug Administration (FDA) pediatric rare disease designation.
In the interim analysis of a phase 2 trial released in May last year, the incidence of hypoglycemia decreased significantly. After eight weeks of treatment, episodes of hypoglycemia, defined as blood glucose falling to 70 mg/dL or lower, were reduced by about 72%, and severe hypoglycemia fell by more than 87%.
Meanwhile, in the second half, results from a phase 1 trial of the next-generation obesity candidate "HM17321" and a phase 2b trial of "Eposipegtrutide" are also slated for release.
HM17321, unlike existing obesity drugs that focus on appetite suppression, is based on a mechanism that simultaneously promotes muscle gain and fat breakdown. Eposipegtrutide targets three hormonal pathways involved in weight and blood sugar control at the same time.
Heo Hye-min, an analyst at Kiwoom Securities, said, "HM17321 is a pipeline with a relatively high likelihood of technology transfer, and cooperation with global pharmaceutical companies could come into view after the phase 1 data release."