Hanmi Pharmaceutical's efpeglenatide aims to challenge Wegovy and Mounjaro dominance

Hanmi Pharmaceutical's efpeglenatide is emerging as a challenger in the obesity treatment market, targeting patients who prioritize minimizing gastrointestinal side effects. While domestic clinical trials showed a weight loss of approximately 10% over 40 weeks, the drug's commercial success depends on its ability to compete with the efficacy of Wegovy and Mounjaro.

The obesity treatment market has entered a "Warring States period." While GLP-1 (glucagon-like peptide-1) class drugs developed with massive capital from global pharmaceutical companies lead the market, Hanmi Pharmaceutical's domestic new drug, efpeglenatide (efpe), is emerging as a new challenger. Professor Lee Seung-hun of Seoul National University Hospital recently appeared on the "Understanding: All the Knowledge in the World" channel to analyze the scientific principles of obesity drugs and technical trends in the global market.

Hints found in lizard venom: 'Sustainability' is the key to obesity drug technology

GLP-1, the core of obesity treatments, is a hormone secreted in the small intestine. This hormone sends satiety signals to the brain to suppress appetite, promotes insulin secretion, and slows the digestion of food in the stomach. However, in its natural state, GLP-1 has an extremely short half-life of only 1 to 2 minutes because it is instantly decomposed by an enzyme called DPP4 upon entering the body. Professor Lee noted the short duration of the hormone, stating, "The feeling of fullness disappears faster than people think. That is why you feel hungry as soon as you turn around."

To solve this problem, scientists took hints from organisms in nature. Professor Lee explained, "It was discovered that one of the venom components of the Gila monster is about 50–60% similar to human GLP-1." He added that "Exendin-4," extracted from this venom component, had the characteristic of decomposing much slower than natural GLP-1, allowing the effect to last much longer. The core theme of early obesity drug development focused on this: "how to maintain the drug effect for a long time (securing sustainability)." Early drugs using Exendin-4 increased the half-life to 2.4 hours, and as technology advanced, the direction evolved toward increasing the administration interval. Novo Nordisk's Saxenda increased the half-life to 13 hours to enable once-daily administration, which eventually opened the era of Wegovy and Mounjaro, which only require a once-weekly injection.

The market is currently expanding from injection-based treatments to oral medications. The video cited orforglipron, developed by Chugai Pharmaceutical (a subsidiary of Roche in Japan) and acquired by Eli Lilly, as an example. This drug was introduced as a technology realizing the dream of oral obesity drugs, much like aspirin, because it is made in the form of a "small molecule drug (chemical drug)" that has nothing to be decomposed, unlike proteins or peptides.

Hanmi Pharmaceutical's 'efpe': Dilemma between technical differentiation and market competitiveness

Hanmi Pharmaceutical's efpe follows a slightly different technical trajectory than the mainstream global drugs like Wegovy or Mounjaro. Efpe applies Fc fusion technology to an Exendin-4-based component. Professor Lee analyzed, "There is an assessment that the technical method used by efpe differs somewhat from the mainstream trend of current global new drug development," adding, "This is a point that could raise concerns in terms of production costs and price competitiveness."

In fact, the clinical results of efpe show both market expectations and cold reality. In domestic clinical trials, efpe showed a weight loss effect of approximately 10% over 40 weeks. This is relatively low compared to the powerful weight loss figures shown by Wegovy or Mounjaro. However, Professor Lee added a caveat, stating, "Since the test periods and conditions are different, it is impossible to conclude the superiority of drug efficacy through simple numerical comparison." Meanwhile, he explained that efpe was previously exported to the global pharmaceutical company Sanofi but was returned, noting this was a result of changes in Sanofi's business strategy rather than defects in the drug efficacy itself.

Competition among global pharmaceutical companies is fierce. Based on the success of Saxenda (liraglutide), Novo Nordisk introduced Wegovy (semaglutide) and Ozempic. Eli Lilly is leading the market by developing Mounjaro through Trulicity (tirzepatide). These companies are staking everything on securing patents and increasing market share through new drugs with different structures.

Will it target a 'niche market' with reduced side effects? The key to commercial success

The strategy for efpe to survive in a market preempted by global giants is "side effect management" and "price." Currently, the most common side effects of GLP-1 class treatments are gastrointestinal symptoms such as nausea and vomiting. Efpe can claim the strength that these side effects appeared relatively less during the clinical process. Professor Lee predicted, "For patients who value minimizing side effects and medication adherence over high weight loss effects, efpe could be a valid option."

Ultimately, the success or failure of efpe depends on "commercial competitiveness" beyond medical achievements. In a situation where Wegovy and Mounjaro have already dominated the market with strong brand power and efficacy, efpe must secure price competitiveness or prove a clear advantage in terms of side effects. Professor Lee emphasized, "It is true that efpe has achieved clinically meaningful results, but to succeed in the market, it must demonstrate differentiated competitiveness."

The obesity treatment market is now facing another inflection point with the emergence of oral medications like Poundayo, moving beyond injections. Industry attention is focused on which path the domestic new drug efpe will take to settle into the market amidst the intense waves of global companies.

Source: original video (YouTube)