South Korean biotech Genexine has failed to secure domestic marketing approval for its long-acting anemia injection Epeusa (epoetin alfa, pre-filled syringe), after the Ministry of Food and Drug Safety (MFDS) cited deficiencies in chemistry, manufacturing, and controls (CMC) and risk management plan documentation. The company plans to resubmit after addressing the feedback.
Regulatory setback
Genexine disclosed on March 4 that the MFDS had rejected its marketing authorization application for Epeusa, submitted in January 2024—over two years and five months earlier. The regulator requested additional supplementary data on CMC and risk management, according to the company’s public filing.
Company response
Genexine stated it will supplement the MFDS review comments and resubmit the marketing application as soon as possible. The company did not provide a specific timeline for the resubmission.
Product profile
Epeusa is a long-acting injectable designed for once-monthly administration, aiming to improve dosing convenience over conventional erythropoiesis-stimulating agents for anemia in non-dialysis chronic kidney disease patients.
What buyers should watch
Overseas distributors and clinic buyers should monitor Genexine’s resubmission progress, as CMC issues may delay market entry. The product’s monthly dosing profile could appeal to clinics seeking patient compliance advantages, but regulatory hurdles in South Korea may affect global supply timelines and partnership opportunities.
Source: Read the original report | Published: June 04, 2026