Pharma Pushes Boundaries: Drug Indications Expand Amid Rising Competition (Image courtesy of Yonhap)
SEOUL, May 5 (Korea Bizwire) — As global competition heats up in the pharmaceutical and biotech sectors, major players in South Korea and abroad are accelerating efforts to expand the therapeutic indications of existing drugs—a strategy aimed at maximizing product value and securing wider market share.
According to industry sources on May 4, Korea Novo Nordisk is seeking regulatory approval to extend the indication of its obesity treatment Wegovy to adolescents aged 12 and older.
Currently approved in South Korea for use in adults with a body mass index (BMI) of 30 or higher, Wegovy could soon be prescribed to younger patients if the application is approved by the Ministry of Food and Drug Safety.
The company also plans to submit an additional application later this year to expand the drug’s indication to include Metabolic Dysfunction-Associated Steatohepatitis (MASH), formerly known as Non-Alcoholic Steatohepatitis (NASH).
If approved, Wegovy would offer new treatment options for both adolescent obesity and MASH—conditions with rising global prevalence.
Originally developed to control blood sugar in diabetic patients, Wegovy gained traction after clinical trials revealed its effectiveness in weight reduction, paving the way for its reclassification as an obesity medication.
Korean and global firms seek new uses for existing medications to boost value, reach broader patient groups, and defend market share. (Image supported by ChatGPT)
Meanwhile, HanAll Biopharma’s U.S. partner, Immunovant, has expanded the indications for its next-generation FcRn antibody HL161ANS to include Sjögren’s syndrome and cutaneous lupus erythematosus. These are both chronic autoimmune diseases involving abnormal immune responses that can significantly affect quality of life.
Immunovant had previously targeted the drug toward four conditions, including myasthenia gravis and refractory rheumatoid arthritis. The update brings the total target indications to six.
Daewoong Bio has also broadened the scope of its diabetes drug Fosidapa, a generic version of AstraZeneca’s Forxiga. With the inclusion of chronic heart failure and kidney disease as approved indications, Fosidapa now effectively replaces Forxiga, which was voluntarily withdrawn from the market in December 2024, leaving a gap in treatment coverage.
In the veterinary segment, cancer immunotherapy developer Vaxcell Bio is also extending the application of its canine immunotherapy drug Vaxleukin-15. Initially indicated for mammary tumors in dogs, the company plans to expand its use to treat canine lymphomas and other cancers.
Analysts note that indication expansion has become an increasingly vital strategy for pharmaceutical companies facing tighter competition and shorter product life cycles. By repositioning a single compound for multiple diseases, firms can both differentiate themselves and tap into new patient populations.
Novo Nordisk’s Wegovy, for instance, faces looming competition from Eli Lilly’s upcoming Mounjaro and other domestically developed anti-obesity drugs. Broader indications could help Wegovy capture a larger market segment and retain an edge.
“Expanding a drug’s indication means the same product can be applied across different therapeutic areas,” said one industry executive. “It creates opportunities to grow revenue and market share while leveraging existing R&D.”
“Sometimes you end up targeting disease areas that were once considered unrelated,” the executive added. “That cross-sector potential can deliver significant strategic gains.”
Ashley Song (ashley@koreabizwire.com)
