Hanmi Pharmaceutical's first domestically developed glucagon-like peptide-1 (GLP-1) class obesity treatment has been approved by the Ministry of Food and Drug Safety (MFDS). As the local obesity treatment market, dominated by Novo Nordisk's Wegovy and Eli Lilly's Mounjaro, now sees the entry of a homegrown drug, its potential impact on the market landscape is drawing attention.
The MFDS announced on the 7th that it approved Effpeo Injection (ingredient name: efpeglenatide) in 2mg, 4mg, 6mg, 8mg, and 10mg doses as the 45th domestically developed new drug.
The approved indication is chronic weight management for adult obese or overweight patients without diabetes, used as an adjunct to a reduced-calorie diet and exercise. It works by acting on GLP-1 receptors distributed in the central nervous system and gastrointestinal tract to suppress appetite, delay gastric emptying, and maintain satiety.
Effpeo Injection is a new drug developed based on efpeglenatide, which was initially licensed out to a global big pharma but returned. In 2015, it was exported to Sanofi for development as a diabetes treatment but the rights were returned in 2020.
Hanmi Pharmaceutical continued in-house development without abandoning the compound, preparing for commercialization as an obesity treatment. The company applied its proprietary biopharmaceutical platform, “Lapscovery.”
This approval marks Hanmi's successful reattempt to develop the drug as an in-house new drug after the technology return, forming a competitive structure as the first domestic drug in the obesity treatment market led by global big pharma.
For Effpeo Injection to secure a meaningful market share in South Korea, it will need to establish a competitive price compared to Mounjaro and Wegovy. Currently, Wegovy and Mounjaro range from at least 200,000 won to over 600,000 won depending on the dose. If Effpeo Injection is priced lower, it could attract latent demand from patients hesitant due to cost concerns.
According to Hanmi's interim results from a phase 3 clinical trial involving 448 South Korean adult obesity patients, the efpeglenatide group showed an average weight reduction of 9.75% at week 40.
Mounjaro recorded a maximum reduction of approximately 22.5-25% over 68-72 weeks, while Wegovy showed an average reduction of 14.9-17% after 68 weeks.
With domestic approval secured, overseas business is expected to accelerate. In January, Hanmi signed an exclusive distribution agreement with Mexico's Sanfer for efpeglenatide and its diabetes treatment Dapagliflozin family. The company will now proceed with local approval processes based on the domestic approval.
Hanmi is also expanding the application of efpeglenatide. In April, it began the first dosing in a phase 3 clinical trial for combination therapy in type 2 diabetes patients whose blood sugar is not sufficiently controlled with metformin and SGLT2 inhibitors. Separate from the obesity treatment approval, the company is pursuing diabetes treatment development to expand long-term prescription bases.
