Genexine Receives Approval for Phase 3 Clinical Trial of Long-Acting Anemia Treatment 'GX-E4' in Korea
[Asia Economy Reporter Kim Ji-hee] Genexine announced on the 1st that it has received approval from the Ministry of Food and Drug Safety for the Phase 3 clinical trial IND of the long-acting EPO 'GX-E4' for the treatment of anemia in non-dialysis kidney disease patients.
This clinical trial is being led by Genexine and KG BIO, a subsidiary of Kalbe Farma, a pharmaceutical company in Indonesia. Genexine licensed the development and business rights for GX-E4 in the ASEAN, Middle East, and North Africa regions to KG BIO during the Phase 2 clinical stage.
Since March last year, KG BIO has been conducting a Phase 3 clinical trial involving 386 non-dialysis kidney disease patients. With the recent approval to conduct the trial in Korea, the number of countries where the clinical trial is being conducted has increased from six ASEAN countries including Indonesia, Taiwan, and Australia to seven countries.
A Genexine official stated, "The Phase 3 clinical trial of GX-E4 is significant as it is the first multinational Phase 3 clinical trial based on Genexine's technology platform and also the first Phase 3 clinical trial conducted by Genexine in Korea."
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GX-E4 is a long-acting erythropoietin (EPO) developed using Genexine's antibody fusion technology platform. It is an improved biopharmaceutical designed to maintain efficacy in the body longer compared to existing products. By enabling once-monthly dosing, it enhances patient convenience compared to existing products that require dosing three times a week or once a week. Furthermore, through Phase 1 and 2 clinical trials, it has demonstrated efficacy equal to or greater than that of commercialized competing products. It also boasts superior cost competitiveness in production processes and manufacturing costs. Upon completion of Phase 3 and commercialization, it is expected to rapidly increase market share, focusing on the ASEAN, Middle East, and South American regions.
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