[비즈한국] Domestic anti-obesity drugs are set to enter the local market in earnest, which has been dominated by Wegovy and Mounjaro. This follows the Ministry of Food and Drug Safety's (MFDS) approval of an anti-obesity drug from Hanmi Pharmaceutical. While price and supply competitiveness based on domestic production are key strengths, there are clear hurdles to overcome regarding weight-loss efficacy and market preemption.
On the 7th, the MFDS approved Hanmi Pharmaceutical’s ‘Efpe-Auto Injector 2, 4, 6, 8, 10mg (efpeglenatide)’ as the 45th new drug in Korea. It is a once-weekly injectable intended as an adjunct to a low-calorie diet and exercise for chronic weight management in obese or overweight adults without diabetes.
Efpe is an anti-obesity treatment that utilizes ‘LAPSCOVERY,’ a long-acting platform technology developed in-house by Hanmi Pharmaceutical. It helps induce weight loss by acting on GLP-1 receptors to suppress appetite and delay gastric emptying, thereby maintaining a sense of satiety.
A market grown by Wegovy and Mounjaro… reaching 800 billion won in just one year
The domestic anti-obesity market that Efpe is entering has expanded rapidly over the past two years with the arrival of GLP-1 class treatments from global pharmaceutical companies. According to the pharmaceutical market research firm IQVIA, the domestic anti-obesity market grew more than threefold in just one year, from 242.6 billion won in 2024 to 819.5 billion won last year.
Wegovy and Mounjaro were the primary drivers of this market growth. Last year, sales of Novo Nordisk's Wegovy were estimated at 483.3 billion won, while Eli Lilly's Mounjaro reached 220.9 billion won. Combined, sales of these two products totaled 704.2 billion won, accounting for approximately 86% of the entire market.
For Hanmi Pharmaceutical, while the fact that Wegovy and Mounjaro have expanded the market is an opportunity, their early market dominance is inevitably a burden. As these global products have already built up extensive prescription experience and brand recognition, Hanmi must present a differentiated choice—whether through price, supply stability, or treatment strategies optimized for domestic patients—to carve out a space in the local market.
One card Hanmi Pharmaceutical can play is domestic production. Efpe will be produced at the Hanmi Pyeongtaek Bio Plant. Unlike Wegovy and Mounjaro, which are imported as finished products, the ability to manage the entire process from production to supply domestically is seen as a key advantage for supply stability.
Price will also be a variable influencing its market settlement. As the domestic anti-obesity market is a non-reimbursable one where patients bear the full cost, the financial burden increases with long-term use. Although Hanmi has not yet disclosed the final supply price for Efpe, securities firms expect it to be set lower than that of Wegovy and Mounjaro. DS Investment & Securities estimated that the 4-week supply price for Efpe would be in the mid-100,000 won range. If the rumored price of around 150,000 won becomes a reality, it could reduce the financial burden compared to Wegovy and Mounjaro, even based on starting dosages.
Price competition is expected to intensify once Efpe is launched. Even Wegovy, which landed in Korea earlier, lowered its starting dose supply price from 372,000 won to 216,000 won ahead of Mounjaro’s entry. Mounjaro’s starting dose supply price is around 278,000 won.
A Hanmi Pharmaceutical official stated, “The final price will be determined by comprehensively reflecting the market environment, distribution structure, clinical value of the product, and sustainable supply conditions after approval,” adding, “We plan to lower the barriers to entry and increase treatment accessibility by offering a more economical price to reduce the cost burden for patients requiring long-term treatment.”
Price and supply alone aren’t enough… challenges remain in weight-loss efficacy and market preemption
Efpe markets itself as an ‘anti-obesity treatment tailored for Koreans.’ Unlike existing GLP-1 class treatments where patients with severe obesity made up a significant portion of Western clinical trials, Hanmi’s strategy is to target overweight and Stage 1 obese patients, who make up a relatively higher proportion of the domestic population. The Phase 3 clinical trial was also conducted on 448 Koreans.
In the 40-week domestic Phase 3 clinical results released by Hanmi, the average weight loss rate for the Efpe group was 9.75%. 79.42% of patients lost at least 5% of their body weight, 49.46% lost at least 10%, and 19.86% lost at least 15%. In women with a BMI of less than 30 kg/m², weight decreased by an average of 12.20%, with a maximum weight loss rate of 30.14% for an individual patient.
While there are limitations in comparing clinical data directly to determine drug superiority due to differences in trial duration, patient groups, and clinical design, the weight-loss efficacy of Efpe appears to lag behind Wegovy and Mounjaro based on raw numbers. Wegovy showed an average weight loss of 14.9% over 68 weeks, and Mounjaro recorded average weight loss rates of 15.0% for the 5mg group, 19.5% for the 10mg group, and 20.9% for the 15mg group after 72 weeks of administration in the SURMOUNT-1 trial.
From drugs to obesity management… expanding to digital convergence medicine
Starting with the launch of Efpe, Hanmi Pharmaceutical plans to fully implement its H.O.P strategy. H.O.P (Hanmi Obesity Pipeline) is a project to develop new anti-obesity drugs that encompass everything from treatment to management and prevention. The goal is to build an end-to-end portfolio for obesity management by connecting Efpe with next-generation anti-obesity drugs, oral treatments, and digital therapeutics.
Hanmi Pharmaceutical is expanding Efpe’s indications to diabetes and is also pursuing the development of digital convergence medicine. This approach combines drug treatment with digital therapeutic devices to provide not just medication, but also lifestyle management such as diet and exercise. The strategy is to increase patient medication adherence and integrate individualized obesity management into a single treatment system.
Given that obesity is a chronic disease where maintaining weight and lifestyle management after stopping medication is crucial, there is significant potential for combining it with digital technology. If Hanmi succeeds in its plan to develop digital convergence medicine, it can shift the standard of competition from the weight-loss efficacy and price of individual drugs to the broader field of long-term patient management.
A Hanmi Pharmaceutical official stated, “We are making company-wide efforts to supply Efpe to the market as early as the end of this month.”