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KGbio Received Market Approval for Efesa

KGbio Received Market Approval for Efesa

PT Kalbe-Genexine Biologis (KGbio) received a distribution permit from BPOM for Efesa. Efesa is the world's first therapeutic drug product containing the active ingredient Efepoetin Alfa (Long-acting erythropoietin (EPO)). Efesa is a medicine for patients of Chronic Kidney Disease (CKD) which plays a role in helping the production of red blood cells in the patient's body.

Efesa was developed by Genexine, Inc. together with PT Kalbe-Genexine Biologics (KGbio). Efesa has gone through phase 3 clinical trials in 7 countries, namely Indonesia, Australia, Taiwan, the Philippines, Thailand, Malaysia and Korea. The process of making Active Pharmaceutical Ingredients (API) and finished products is carried out at PT Kalbio Global Medika. BPOM has also assisted the Efesa development process since 2018, starting from the construction of production facilities for API and finished products, the clinical trial process, until the product successfully obtained a marketing authorization approval.


KGbio at a Glance

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. The business model revolves around in-licensing novel biologics and select biosimilars in oncology and high-specialty therapeutic areas (typically pre-IND or early clinical stage), with the objective to out-license them in target geographies after finishing clinical development as well as regulatory and reimbursement approvals.

Platforms of interest include Fc-fusion proteins, antibodies, bispecifics, ADCs, cell therapies and therapeutic vaccines. The company is backed by Asian pharma companies Kalbe, Genexine and US private equity giant General Atlantic.

Genexine at a Glance

Genexine, Inc. is a publicly traded, clinical-stage biotechnology company focused on developing and commercializing immunotherapeutics and next-generation long-acting biologics. Its primary technology platforms are Therapeutic DNA vaccine technology and hyFc® fusion technology. The Company has multiple products in clinical development including several undergoing Phase 3 registration trials. The Company's proprietary pipeline includes GX-188 (tirvalimogene teraplasmid) for cervical cancer, GX-I7 (efineptakin alfa) for multiple cancers, GX-H9 (eftansomatropin alfa) for Pediatric Growth Hormone Deficiency and GX-E4 for CKD-induced anemia, among others. Genexine has established multiple partnerships with global companies in order to expedite product development and commercialization and create significant value. Genexine is listed on the Korean exchange (KOSDAQ: 095700) and is headquartered in Seoul, Korea. Genexine is committed to the well-being and care of patients worldwide.

KGM at a Glance

Kalbio Global Medika (KGM) is one of the first and the pioneer of biopharmaceuticals in Indonesia, established in 2014 and inaugurated officially in 2018 by the President of the Republic of Indonesia, Ir. Joko Widodo. KGM is part of the Kalbe Group, a subsidiary of PT Kalbe Genexine Biologics (KGbio), which is a clinical-stage biotechnology company focused on bringing biologics medical innovation to markets outside US/Canada, Western Europe, and China. KGM is an Innovative CDMO, equipped with CMC and scale-up capabilities plugged into Boston biotech ecosystem and state-of-the-art facility to enhance efficiency and productivity. With API manufacturing, formulation, fill and finish capabilities of biosimilar and novel biologics, averaging 10 million units of syringes, cartridges, and vials, KGM supplies local and international markets.



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