[Edaily Reporter NA EUN-KYUNG ] All eyes are on whether “Epe,” the first domestically developed glucagon-like peptide (GLP)-1 class obesity drug from Hanmi Pharmaceutical ( HanmiPharm(128940)), will serve as a catalyst for the commercialization of subsequent obesity treatments. Industry analysts suggest that HanmiPharm will prioritize securing a prescription base and real-world patient data by lowering the price barrier, even if initial profitability is low. Domestic obesity drug developers are also expressing optimism, as Epe could potentially broaden the base of the domestic obesity drug market if it prompts competing drugs to lower their prices as well.

According to HanmiPharm on the 12th, the company is reviewing the final supply price with the goal of delivering the first batch of Epe by the end of this month. A HanmiPharm official stated, “We have never disclosed the price range for Epe to the public, and it has not actually been decided yet,” adding, “However, we will definitely adhere to the principle of improving patient access.”

‘Epe’ Expected to Gain Market Share by Reducing the Cost Burden of Long-Term Obesity Treatment ‘Epe’

is a once-weekly injectable drug approved in five dosages: 2, 4, 6, 8, and 10 mg. It is indicated for obese patients with a body mass index (BMI) of 30 or higher, or for patients with a BMI of 27 or higher but less than 30 who have one or more weight-related comorbidities, such as hypertension or dyslipidemia.

In a Phase 3 clinical trial involving 448 obese adult patients in South Korea, Epe demonstrated an average weight loss rate of 9.75% after 40 weeks. While direct comparisons are limited due to differences in trial duration and patient populations, the average weight loss rate was lower than that of Wegovy (14.9% at 68 weeks) and Mounjaro (20.9% at 72 weeks); however, fewer gastrointestinal side effects were observed.

There are also calls for a cautious evaluation of the clinical evidence for Koreans presented by HanmiPharm. A professor in the Department of Endocrinology at a university hospital noted, “While the blood glucose-lowering effect of GLP-1 agonists appears to be slightly stronger in TONGYANGs, there do not seem to be significant racial differences in effects such as weight loss.” He added, “Although the existence of a study on Koreans is meaningful in itself, the clinical trial itself was relatively small in scale and did not last very long. In contrast, other drugs have been studied over the long term, and various studies have been conducted in areas such as cardiovascular health.”

In this regard, price is the key factor that will determine the drug’s success in the market. Analysts suggest that if the monthly out-of-pocket cost for patients can be reduced to the 100,000 won range, Epe could gain a competitive edge even against global Big Pharma. Some in the industry even speculate that the supply price for a four-week supply of the low-dose formulation could be set below 100,000 won.

GLP-1-class obesity drugs are typically started at a low dose and gradually increased to minimize the risk of side effects. The manufacturer’s suggested retail price for a four-week supply at the standard starting dose is 216,000 won for Wegovy and 278,000 won for Mounjaro. The actual out-of-pocket cost for patients is higher than these figures due to the addition of distribution and medical service fees. In particular, obesity treatment in South Korea is not covered by health insurance, so patients must bear the full cost of the medication.

Cho Young-min, a professor in the Department of Endocrinology at Seoul National University Hospital, said, “If the monthly medication cost is 100,000 won or less, the price difference compared to existing products will be significant, so many patients will likely want to use it,” adding, “I believe that if Epe is priced affordably, it will greatly contribute to driving down drug prices competitively across the entire market.”

Kim Dae-jung, a professor in the Department of Endocrinology at Ajou University Hospital, also explained, “Since obesity medications are used long-term—typically for six months to a year—many patients find it difficult to begin treatment if they have to pay 300,000 won per month.” He added, “Due to the cost, doctors often hesitate to recommend treatment, and patients frequently discontinue it.” Regarding the patient’s monthly out-of-pocket cost, he noted, “If the cost is around 150,000 won for the low dose and 200,000 won for the high dose, doctors would feel less burdened about recommending the medication.”

Furthermore, since the extent of efficacy and side effects varies from patient to patient, Epe offers the advantage of providing patients with a wider range of options, allowing them to find the treatment that best suits their individual needs as they continue taking the medication.

“For HanmiPharm, securing data will be more important than initial profitability”

HanmiPharm highlights Epe’s strength as its ability to produce everything from raw materials to finished products domestically, allowing it to respond nimbly to changes in demand. In particular, as recently as early this year, there were shortages of Wegovy and Mounjaro, as well as regional supply disruptions in South Korea. Professor Kim recalled, “As supply was concentrated in areas with high volumes of weight-loss drug prescriptions, facilities that prescribed them only intermittently sometimes struggled to secure sufficient quantities.” However, supply issues similar to those experienced at the time have since eased.

Domestic production is also crucial for managing manufacturing costs. HanmiPharm’s Pyeongtaek Bio Plant No. 2—for which the company invested 286.1 billion won in new construction and equipment following the technology export to Sanofi—saw its operating rate drop to 0% at one point due to the return of rights and delays in securing production volumes. Expanding production of Epe and other products could serve as an opportunity to increase facility utilization and reduce cost burdens. A HanmiPharm official stated, “The target operating rate for the Pyeongtaek plant—including Efe and other products—is 70% this year and 90% next year.”

However, initial profitability cannot be guaranteed by in-house production alone. A bioindustry official pointed out, “To secure profitability at low prices, we must increase sales volume and lower costs,” adding, “Since there are limits to how much costs can be reduced, we need to boost sales volume; however, in a market already dominated by existing products, it is difficult to raise market share to 5–10% right from the start.” This suggests that if initial sales volume is limited, there may be constraints on securing sufficient profitability.

Some analysts also argued that Epe’s success should not be limited to initial profits alone. An executive at a domestic obesity drug developer emphasized, “HanmiPharm’s primary goal with Epe is likely to lay the groundwork in advance for the market entry of follow-on products,” adding, “Real-world data (RWD) is an incredibly valuable asset; accumulating it can be highly beneficial for obtaining overseas approvals and for further development.” They also noted that even if initial profitability is low, accumulating prescribing experience and data could support the commercialization—such as technology exports—of HanmiPharm’s follow-on obesity drugs, which the company prioritizes over Epe.

HanmiPharm is currently conducting a Phase 2 clinical trial for HM15275, a triple-action agent targeting GLP-1, glucose-dependent insulinotropic polypeptide (GIP), and glucagon (GCG). HM17321, a urocortin 2 (UCN2) analog designed to simultaneously reduce fat and increase muscle mass, is also in Phase 1 clinical trials, and In August, the company licensed the global rights (excluding Korea) for this candidate to Genentech in a deal worth up to $2.3 billion (approximately 3.2 trillion won), including an upfront payment of $190 million (approximately 260 billion won).

For the expansion of Epe’s prescriptions to serve as a foundation for follow-on products, the company must also overcome pricing competition from rival drugs. Previously, in August of last year, Novo Nordisk Korea lowered the wholesale price of a four-week supply of the starting dose of Wegovy from 372,000 won to 216,000 won—a reduction of approximately 42%—ahead of the launch of Lilly Korea’s Mounjaro. However, a representative from Novo Nordisk Korea stated, “At this stage, there are no discussions regarding a price reduction for Wegovy.”

The expansion of prescriptions driven by price competition is expected to present an opportunity for domestic companies developing differentiated obesity drugs. An executive at an obesity drug developer mentioned earlier predicted, “If price competition intensifies, revenue per patient will decrease, but the number of patients using the drug will increase,” adding, “As the market grows—including patients who want lower prices, those who prefer once-a-month dosing, and those seeking rapid weight loss—the market will segment according to specific patient needs.” Accordingly, he expected that the barrier to entry for subsequent developers entering the market with differentiated products would also be lowered.

However, the government’s future efforts to strengthen oversight of misuse could become a variable in market expansion. This is because the Ministry of Food and Drug Safety is moving to designate GLP-1-based obesity treatments as drugs of concern regarding misuse. An official in the biotech industry stated, “While oversight of GLP-1 obesity drug misuse is expected to be strengthened, we’ll have to wait and see to what extent government regulations will be implemented, given that these drugs currently remain in the non-reimbursed market.”