Genexine, KGbio receive Indonesian marketing approval for novel long-acting erythropoietin, Efepoetin alfa to treat CKD induced anaemia in non-dialysis patients

Genexine, a publicly-listed clinical-staged Korean biopharmaceutical company, together with PT Kalbe Genexine Biologics (KGbio), a joint venture clinical-stage biotechnology company between Genexine and PT Kalbe Farma announced the approval of its long-acting erythropoietin, Efepoetin alfa (GX-E4), by the Indonesian Ministry of Food and Drug Safety (BPOM) for the treatment of chronic kidney disease induced anaemia in non-dialysis patients. This milestone marks the first market approval for a drug originating from Genexine's research and development with KGbio.

Genexine, in collaboration with KGbio, has been co-developing Efepoetin alfa for CKD patients in both non-dialysis and dialysis settings. While this BPOM approval specifically pertains to the treatment of CKD-induced anaemia in non-dialysis patients, it is anticipated that further approvals for dialysis patients with CKD-induced anaemia will be secured in due course.

Furthermore, a multinational phase 3 clinical trial targeting dialysis patients is set to commence in the Q4 of 2023, spearheaded by Genexine and KGbio. This study will be conducted across 11 countries in Europe and Asia to facilitate a label expansion including both dialysis and non-dialysis patient populations.

“We are thrilled to have our first-ever product approval,” said Sungjune Hong, CEO of Genexine. “This is a landmark result for everyone at Genexine and our partner KGbio and represents our first market approval of therapeutic drugs that have been discovered, developed, and commercialized by a Korean BioPharma company. Our efforts to focus on commercialization over the past year have been successful and we now look to roll out this product in several other Asian countries and expand the indication to include dialysis patients. Efepoetin alfa was one of the products developed using our proprietary hyFc fusion platform and demonstrates our ability to deliver a novel long-acting EPO drug to patients suffering from CKD-induced anaemia.”

President Director of PT Kalbe Genexine Biologics, Sie Djohan said “Kalbe believes by receiving market approval for anemia treatment Efepoetin alfa, It is easier for patients to get access to medicines for their recovery."

In 2020, Genexine and KGbio initiated phase 3 clinical trials for non-dialysis patients in a multinational setting, spanning seven countries across Asia and Oceania. These countries included Korea, Australia, Taiwan, as well as Southeast Asian nations such as Indonesia, Malaysia, Thailand, and the Philippines. As of the latest results in April 2023, Efepoetin alfa has demonstrated non-inferiority when compared to Roche's Mircera, exhibiting a good safety and tolerability profile. It successfully met the primary endpoint, achieving a response rate 69.6% in patients whose haemoglobin levels increased by more than 1g/dL, surpassing the 63.2% for Mircera.

Efepoetin alfa (GX-E4) is a bio-better drug for CKD-induced anaemia, developed based on hyFc, Genexine's proprietary long-acting platform technology. As kidney function declines patients with CKD suffer anaemia due to a lack of EPO (Erythropoietin), a hormone that stimulates red blood cell production, approximately 90% of EPO is produced by the kidney. GX-E4 is a long-acting drug that extends the half-life of EPO in the body, that is developed for once every two weeks or once every four weeks injection, compared to the first-generation short-acting EPO product that needs to be injected once every 2 to 3 days.

Genexine, Inc. is a publicly traded, clinical-stage biotechnology company focused on developing and commercializing immunotherapeutic and next-generation long-acting biologics. Its primary technology platforms are Therapeutic DNA vaccine technology and hyFc® fusion technology.

KGbio is a clinical-stage biotechnology company established in 2016, focused on bringing biologics medical innovation to markets outside the US/Canada, Western Europe, and China.

PT Kalbe Farma Tbk. (Kalbe) was established in 1966 and is one of the largest publicly-listed pharmaceutical companies in Southeast Asia. Kalbe has four main divisions managing a broad and strong portfolio of brands; Prescription Pharmaceuticals Division, Consumer Health Division comprising over-the-counter drugs, as well as supplement drink and ready to drink products, Nutritional Division, and Distribution & Logistics Division.

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