Hanmi Pharm's epeglenatide clears Ministry of Food and Drug Safety review as the country's 45th approved new drug; five dosage strengths to launch this year

Drug rebounds from rights reversion with proprietary LapScovery platform delivering flat PK profile; H.O.P project reaches first commercial milestone

"Epe," South Korea's first GLP-1 receptor agonist obesity treatment, developed by Hanmi Pharm. [Hanmi Pharm]
"Epe," South Korea's first GLP-1 receptor agonist obesity treatment, developed by Hanmi Pharm. [Hanmi Pharm]

South Korea has produced its first homegrown new drug in the class of glucagon-like peptide-1 (GLP-1) receptor agonists, joining a global obesity treatment market that has reshaped the pharmaceutical industry.

Industry observers are calling the approval a pivotal turning point — not only for the domestic obesity treatment market, but for South Korea's broader ambitions in biopharmaceutical sovereignty. The drug was developed entirely through independent research and development amid chronic shortages and high prices driven by a handful of global pharmaceutical giants.

The Ministry of Food and Drug Safety announced Wednesday that it had granted manufacturing and marketing approval for Hanmi Pharm's Epe Auto-Injector (epeglenatide) in five dosage strengths — 2, 4, 6, 8 and 10 milligrams — designating it the country's 45th approved new drug.

The drug is a subcutaneous injection indicated for chronic weight management in adults with obesity who do not have diabetes (initial body mass index of 30 kg/m² or above), as well as overweight adults (BMI of 27 to below 30 kg/m²) who have at least one weight-related comorbidity such as hypertension, dyslipidemia or cardiovascular disease. It works by binding to GLP-1 receptors in the central nervous system and gastrointestinal tract, suppressing appetite and slowing gastric emptying to induce satiety.

Following new drug review guidelines established last year, the ministry assembled a dedicated 19-member review team of specialists in biotech, clinical science and quality assurance. Epeglenatide was designated the 62nd target under the ministry's Global Innovative Fast Track (GIFT) program, significantly accelerating its development timeline. The drug completed its marketing authorization application within 20 days of receiving GIFT designation, after interim top-line results from a domestic Phase 3 trial involving 448 adults with obesity at week 40 showed a maximum weight reduction of 30 percent and a mean weight loss rate of 9.75 percent.

The approval has drawn particular attention from the pharmaceutical and biotech industry because it came after overcoming the setback of a rights reversion by a global pharmaceutical company.

Epeglenatide was originally developed as a diabetes treatment and was at the center of a major technology licensing deal in 2015, but the rights were returned in 2020 when French pharmaceutical company Sanofi restructured its business strategy. Hanmi Pharm did not abandon the compound, instead pivoting swiftly to reposition it as an obesity treatment.

The decision was grounded in robust metabolic disease data from a large-scale global Phase 3 trial published in the New England Journal of Medicine and presented at the American Diabetes Association annual meeting in 2021, shortly after the rights reversion. Hanmi Pharm redefined the drug as a tailored treatment optimized for the Korean obesity phenotype — defined at a BMI of 25 kg/m² or above, a lower threshold than Western standards — and filed an investigational new drug application for a Phase 3 clinical trial with the ministry in July 2023, formally launching its independent development program.

Under its in-house obesity initiative, the H.O.P (Hanmi Obesity Pipeline) project, and driven by decisions from senior management including Vice Chairman Lim Joo-hyun and supported by clinical data from its research teams, Hanmi Pharm completed what the industry is describing as a remarkable turnaround — producing South Korea's first GLP-1 obesity drug.

The drug's pharmacological profile also sets it apart from competing global products. Hanmi Pharm's proprietary LapScovery platform achieves a flat pharmacokinetic profile, and a stepwise dose-escalation regimen with intervals of two and then four weeks substantially reduces gastrointestinal side effects such as nausea and vomiting — a persistent limitation of existing GLP-1 agents.

Interim Phase 3 results from 448 Korean adults with obesity showed a mean weight loss rate of 9.75 percent, with a maximum reduction of 30 percent. Some 79.42 percent of patients achieved weight loss of 5 percent or more, and 49.46 percent lost 10 percent or more.

Additional clinical strengths include a demonstrated reduction in major cardiovascular events and renal protective effects, confirmed through a large-scale global Phase 3 cardiovascular outcomes trial involving approximately 4,000 participants conducted during the Sanofi period. Patient adherence has also been maximized through a self-administered auto-injector device available across all five dosage strengths.

The commercial significance is equally notable. The domestic GLP-1 treatment market has grown rapidly to around 2 trillion won ($1.49 billion), but imported products from multinational companies including Novo Nordisk and Eli Lilly have dominated it, fueling persistent supply instability and controversy over high out-of-pocket costs.

Epeglenatide will be manufactured entirely in-house at Hanmi Pharm's Pyeongtaek biopharma plant, from active pharmaceutical ingredient through to finished product, giving it a stable supply chain. The company plans to price the drug competitively to lower the initial barrier to entry and maximize its import-substitution effect.

Epeglenatide will serve as the cornerstone of Hanmi Pharm's next-generation obesity pipeline. Through a lifecycle management strategy aimed at maximizing the product's value, the company is conducting a Phase 3 clinical trial combining the drug with an SGLT-2 inhibitor and metformin for diabetes, targeting approval in 2028. It is also developing prefilled syringe and multi-pen formulations, pursuing South Korea's first digital therapeutics-integrated drug, and expanding into customized health supplement packages.

Further along the H.O.P pipeline, the company is advancing a next-generation triple agonist (HM15275) targeting weight loss of 25 percent or more — comparable to bariatric surgery outcomes — as well as a novel obesity drug (HM17321) designed to simultaneously reduce body weight and increase muscle mass.

The approval is being interpreted as a strategic milestone: Hanmi Pharm turned a crisis — the return of rights by a foreign pharmaceutical company — into a victory through independent clinical capabilities, securing a domestically produced alternative in a market previously monopolized by imported drugs, and opening the door to global commercialization of a next-generation obesity pipeline that extends into muscle-preserving and metabolic disease combination therapies.

"This approval of Epe is highly significant in that we are now able to stably supply a treatment grounded in clinical evidence tailored to the characteristics of Korean patients, moving away from a treatment environment that had depended entirely on imported drugs," said Kim Na-young, executive vice president and head of Hanmi Pharm's innovation and growth division. "We will contribute to improving patients' quality of life through rigorous quality management and a rational pricing structure to ensure a successful launch in the domestic market."


silverpaper@heraldcorp.com