Novo Nordisk and Eli Lilly File for South Korean Approval, Setting Up Launch Race Next Year
核心洞察
Novo Nordisk has filed Wegovy Pill (搜索) (semaglutide) and Eli Lilly has filed Foundayo (搜索) (orforglipron) for South Korean marketing authorization with the Ministry of Food and Drug Safety (搜索).
Both oral candidates launched in the US at $149 per month at the starting dose, roughly 85% below the $1,000 US starting price of injectable Wegovy and Mounjaro.
Hanmi Pharmaceutical targets October approval for its injectable EPPE (搜索), which cut weight 9.75% at 40 weeks in a 448-patient South Korean Phase 3 trial.
Novo Nordisk and Eli Lilly have each filed for marketing authorization in South Korea for oral obesity (搜索) treatments, setting up a launch race that could put pill-form products on the market as early as the second half of next year. Novo Nordisk submitted Wegovy Pill (搜索) (semaglutide) and Eli Lilly submitted Foundayo (搜索) (orforglipron) to the Ministry of Food and Drug Safety (搜索). Neither company has disclosed specific launch timelines, though the filing-to-launch interval in the country is typically about a year.
Both drugs act on glucagon-like peptide-1 (GLP-1) receptors but differ in composition and dosing. Wegovy Pill (搜索) uses the same peptide-based ingredient as injectable Wegovy and must be taken on an empty stomach with water, followed by a period of avoiding food, because it requires an absorption enhancer. Novo Nordisk reported in April that Wegovy Pill's weight-loss effect averaged about 3 percentage points higher than Foundayo (搜索)'s, and its own analysis put the likelihood of discontinuation due to adverse reactions about four times higher with Foundayo. Foundayo is a small-molecule synthetic drug without those dosing restrictions. Both oral products launched in the US at $149 per month at the starting dose, against a $1,000 US starting price for injectable Wegovy and Mounjaro.
In South Korea, Hanmi Pharmaceutical is in the final stages of approval for its injectable obesity (搜索) drug EPPE (搜索), with an October target for authorization and a launch planned within about a month of approval and within this year. In a Phase 3 trial at multiple South Korean university hospitals in 448 obese patients, EPPE produced an average weight reduction of 9.75% after 40 weeks, and 12.20% in the subgroup of women with a BMI below 30. EPPE will be produced at the Pyeongtaek Bio Plant. Current four-week starting-dose wholesale prices are ₩216,000 for Wegovy 0.25mg and ₩278,000 for Mounjaro 2.5mg; industry observers suggest EPPE could launch in the ₩100,000 range, while Hanmi said no price has been determined. Novo Nordisk previously cut Wegovy's wholesale prices by roughly 10% to 40% by dosage in August of last year ahead of Mounjaro's South Korean launch.