Genexine seeks approval for anemia treatment in Korea

Genexine's anemia treatment Efesa (Genexine)

Korean biotech firm Genexine announced Friday that the company has submitted a biologics license application to the country's Ministry of Food and Drug Safety for the company’s anemia treatment Efesa.

Efesa is intended for the treatment and maintenance of anemia induced by chronic kidney disease with or without dialysis. The drug candidate uses GX-E4, a long-acting erythropoiesis stimulating agent.

Genexine has used its own hyFc fusion protein technology to maximize the half-life of the drug, the company explained. Patients taking a first-generation anemia treatment will dose every two or three days, but Efesa has a longer half-life, requiring a dose every two to four weeks.

In 2020, under its partnership with Kalbe in Indonesia, Genexine started phase 3 clinical trials for patients with non-dialysis CKD in seven countries, including South Korea.

In these trails, 391 adult patients with non-dialysis CKD joined. The results showed that the response rate of GX-E4 was 75.6 percent, while Roche's third-generation anemia drug Mircera maintained a response rate of 69.3 percent. An equivalent safety performance was also confirmed compared to Mircera, according to Genexine.

In Indonesia, KG Bio, a joint venture between Genexine and Kalbe, received marketing authorization from the Indonesian drug authorities last year.

“Genexine will make all-out efforts to win the authorization in Korea, in addition to Indonesia,” an official from Genexine said.

Meanwhile, Genexine is also preparing for phase 3 global clinical studies involving patients with CKD who require dialysis. The company plans to recruit 429 patients from 11 countries.

By Shim Woo-hyun(ws@heraldcorp.com)