Genexine recently released positive interim findings from the Phase III clinical trial of GX-E4 (Efepoetin alfa) for anemia induced by chronic kidney disease (CKD) or renal anemia in non-dialysis patients. Interim analysis confirms GX-E4 is non-inferior to Roche’s Mircera, a third-generation long-acting anemia treatment. As it advances towards regulatory submission in various APAC countries, Genexine will have an opportunity to revolutionise the renal anemia market in the APAC region, including South Korea, if approved, says GlobalData, a leading data and analytics company.

GX-E4 involves the fusion of epoetin with hybrid human crystallisable fragment (Fc) molecules, resulting in increased stability and a longer plasma half-life. The company began the official biologics license application (BLA) process in Indonesia, followed subsequently by an application in the South Korean market.

Manoj Kumar Lingala, Pharma Analyst at GlobalData, comments: “Current treatment guidelines suggest that renal anemia should be treated mainly with iron therapies and erythropoiesis-stimulating agents (ESAs). ESAs are the preferred treatment option over iron therapies due to their ability to reduce cardiovascular morbidity and mortality, decrease blood transfusion requirements, and improve symptoms.”

Renal anemia cases are increasing In South Korea, necessitating the development of effective therapies for renal anemia. According to GlobalData Pharma Intelligence Center, South Korea’s prevalent cases of renal anaemia are expected to rise to 137,612 by 2028 from 123,493 in 2022.

In South Korea, multinational companies offer various ESA therapies, including first-generation Eposis (Daewoong), administered three times per week; second-generation Nesp (Kyowa Kirin Korea/Amgen), administered once per week; and third-generation Mircera (Roche), administered biweekly or monthly.

Lingala concludes: “GX-E4 presents a favorable opportunity for Genexine to compete with current ESA agents and provide patients with increased convenience by reducing the frequency of administration to once a month (a feature only offered by Mircera). Additionally, the company could achieve greater market penetration through competitive pricing and an effective commercialization strategy.”