Genexine said Monday that the company has begun administering its long-acting anemia treatment GX-E4 for phase 3 trials in six countries, including Indonesia and Australia.

KG BIO, a joint venture of Genexine and Indonesian pharmaceutical, Kalbe Farma, is conducting the clinical study. Genexine transferred the development and business rights of GX-E4 to KG BIO during the phase 2 clinical trial.

The company gave the administration to the first patients at the University of Malaya Medical Centre in Malaysia on Aug. 19. It plans to speed up the recruitment of 386 non-dialyzed kidney disease patients with anemia at 45 clinical trial centers in Indonesia, Australia, Taiwan, Philippines, Thailand, and Malaysia.

GX-E4 is next-generation long-lasting erythropoietin (EPO) developed with the company’s antibody fusion technology, hyFcTM, to keep the medicinal effect for a long time in the human body.

The company is looking forward to seeing GX-E4 improve convenience for patients who suffer from anemia caused by chronic renal failure compared to first-generation drugs that require three administrations a week by cutting down to a single dose per month.

“The first global biopharmaceutical clinical trial in Indonesia is drawing great interest and support from the Indonesian government,” Genexine CEO Sung Young-chul said.

Genexine has confirmed the efficacy of GX-E4 better than commercialized products in preclinical, phase 1 and 2 trials. It expects to GX-E4’s market share in the Association of Southeast Asian Nations (ASEAN) region by commercializing it after phase 3 clinical trials based on its excellent manufacturing process and competitive cost.

According to data analysis firms QY Research and GlobalData, the global EPO market's size in 2019 was estimated at 9.2 trillion won ($7.73 billion). The EPO market, including biosimilars, is expected to grow at an annual average of 5.8 percent, reaching 12.84 trillion won in 2025.

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