Genexine said it has completed the biologics license application (BLA) to the Ministry of Food and Drug Safety (MFDS) for Efesa (efepoetin alfa), its anemia treatment.
Developed in collaboration with Kalbe through their joint venture, KGBio, Efesa is a third-generation treatment for renal anemia.
Unlike first-generation treatments requiring bi-weekly or tri-weekly dosing, Efesa has a dramatically extended half-life in the body, necessitating administration only every two to four weeks.
Genexine extended the duration using its hyFc platform technology, enhancing the natural hormone erythropoietin (EPO) to stimulate red blood cell production more effectively.
If MFDS approves it, that will follow the drug's initial approval from the Indonesian Food and Drug Authority (BPOM) after the successful completion of phase 3 clinical trials for non-dialysis chronic kidney disease patients in October last year.
The study involved 391 patients from seven countries, including Korea, demonstrating Efesa’s superiority with a 75.6 percent hemoglobin (Hb) response rate, compared to 69.3 percent for the control group’s Mircera.
“Based on the phase 3 clinical trial results, we plan to complete the application for a new product license with MFDS for treating anemia in patients with non-dialysis chronic kidney disease and begin the full-scale approval process,” a Genexine official said. “We will make every effort to obtain approval in Korea following the approval in Indonesia.”
The official also stressed this would be the first case of a domestic biotech company to complete the entire drug development process from candidate discovery to commercialization.
Genexine also plans to expand the drug's indication by initiating a new phase 3 clinical trial for Efesa in dialysis-dependent chronic kidney disease patients. It will inject the first patient on Jan. 25 as scheduled.
This trial will compare Efesa with Aranesp in terms of efficacy and safety. It will involve 429 patients across 11 countries -- Korea, Taiwan, Indonesia, and eight European nations.
According to data on drug sales performance, the Korean market for anemia drugs was worth about 100 billion won ($74.6 million) last year.