A new decisive phase is coming to South Korea’s biotech sector. Hanmi Pharmaceutical’s Efpeglenatide, the nation’s first homegrown GLP-1 obesity drug, has been granted fast-track review by the Ministry of Food and Drug Safety (MFDS). The move signals a structural shift toward faster domestic commercialization and positions Korea to compete in the rapidly expanding global obesity drug market dominated by U.S. and European players.
Hanmi’s Efpeglenatide Designated for Fast-Track Review
On December 5, Hanmi Pharmaceutical announced that its GLP-1–based obesity drug Efpeglenatide was officially designated by the MFDS as part of its Global Innovative Product Fast-Track (GIFT) program.
The program, established in September 2022, aims to accelerate approval for drugs that show clear medical advancement or fill unmet treatment needs. Products under GIFT receive dedicated review teams, tailored evaluations, and priority scheduling, which shortens approval time by about 25% compared to standard reviews.
Efpeglenatide qualifies as an “innovative new drug” developed by a certified Korean pharmaceutical company. It is the first obesity drug developed entirely with domestic technology to enter this stage of accelerated regulatory assessment.
Efpeglenatide: A National Push for Pharmaceutical Innovation
Hanmi’s GIFT designation aligns with Korea’s broader drive to strengthen its biopharmaceutical innovation capacity under the “Global Innovative Drug Initiative.” This program aims to establish the country as a top-five global biotech power by nurturing high-value R&D pipelines in obesity, metabolic disorders, oncology, and AI-driven drug discovery.
Efpeglenatide stands at the intersection of these priorities. As a GLP-1 receptor agonist, it stimulates insulin secretion, suppresses appetite, and improves metabolic function. The drug’s fast-tracking comes at a time when GLP-1–based drugs such as Ozempic and Wegovy have transformed global pharmaceutical markets, creating a multi-billion-dollar category that Korea is now poised to enter.
Clinical Performance: Promising Data from Phase 3 Trials
Hanmi reported Phase 3 core treatment results in October 2025 from a study involving 448 obese adults without diabetes.
- At the 40-week mark, the average weight reduction reached 9.75%, compared with the placebo group’s negligible change.
- Among women with a BMI under 30 kg/m², the average loss was 12.2%, and the maximum individual reduction reached 30.14%.
- Efpeglenatide also showed a lower incidence of mild gastrointestinal side effects than existing GLP-1 therapies.
The study demonstrated significant improvements in secondary indicators, including BMI, waist circumference, blood glucose, insulin resistance, lipid levels, and blood pressure. Hanmi is conducting a 24-week extension trial (64 weeks total) to evaluate long-term sustainability before commercialization.
Confidence in Early Approval and Market Readiness of Efpeglenatide
Hanmi CEO Park Jae-hyun emphasized the strategic importance of the designation:
“Efpeglenatide’s selection for fast-track review brings us closer to early approval and commercialization as a ‘national obesity drug.’ We are accelerating every process so patients can access it by the second half of next year.”
Executive Vice President Kim Na-young, who leads Hanmi’s New Product Development division, noted:
“Efpeglenatide’s low side-effect profile enhances treatment adherence and allows integrated management of obesity and metabolic disorders. It could serve not only obesity patients but also those with diabetes or high metabolic risk.”
Korea’s Biopharma Confidence Test
Hanmi’s milestone reflects more than a single company’s progress. It underscores Korea’s maturing capacity to develop globally competitive biotech assets. Fast-tracking a fully domestic GLP-1 candidate signals regulatory willingness to prioritize innovation-led health exports and reduce reliance on imported blockbuster drugs.
In recent years, Korea’s biotech and healthcare startups have quietly led the nation’s venture rebound. Since 2023, the bio and medical sectors have accounted for the largest share of domestic venture investment, outpacing the ICT service sector. Yet, structural support and policy prioritization have often lagged behind this performance.
The fast-track designation of Hanmi’s Efpeglenatide could mark a turning point — an early sign that Korea’s innovation policy is beginning to recognize the biotech sector’s strategic importance. With new R&D allocations for pharmaceutical ventures in the 2026 budget, the move suggests that biotech may finally be shifting from an overlooked growth engine to a central pillar of Korea’s next venture boom.
For investors, it marks a policy-backed inflection point in Korea’s biopharma sector — one where accelerated review and domestic R&D pipelines converge. The MFDS’s GIFT initiative mirrors similar pathways in the U.S. FDA’s Breakthrough Therapy program and the EMA’s PRIME scheme, allowing Korea to align with global standards for pharmaceutical agility.
If approved, Efpeglenatide will be Korea’s first homegrown obesity treatment to compete internationally, reinforcing the nation’s ambition to become a regional hub for biotech commercialization.
A Fast-Track Moment for Korean Innovation
Efpeglenatide’s regulatory acceleration encapsulates the next phase of Korea’s biotech journey — one defined by speed, safety, and scalability. As global investors and policymakers watch how Korea executes its innovation agenda, the outcome of this approval could shape future confidence in its biopharma export ecosystem.
The race to commercialize a safe, effective obesity therapy has become a defining benchmark of healthcare innovation. Korea’s first GLP-1 fast-track drug suggests the nation is not only catching up, but now preparing to lead in translating research into real-world therapeutic impact.
– Stay Ahead in Korea’s Startup Scene –
Get real-time insights, funding updates, and policy shifts shaping Korea’s innovation ecosystem.
➡️ Follow KoreaTechDesk on LinkedIn, X (Twitter), Threads, Bluesky, Telegram, Facebook, and WhatsApp Channel.
