Efesa for Anemia Treatment Produced by KGM Has Officially Obtained BPOM Approval
Efesa has succeeded in obtaining marketing authorization approval from BPOM as an innovative medicinal product for anemia patients with Chronic Kidney Disease (CKD) which helps in producting red blood cells in the patient's body. Efesa is the world's first therapeutic drug product containing the Active Pharmaceutical Ingredients (API) Efepoetin alfa (Long-acting erythropoietin (EPO)). Efepoetin alfa extends the half-life of EPO in the body so that the injection only needs to be done every 2-4 weeks, compared to short-acting EPO which needs to be injected every 2-3 days.
Efesa was developed by Genexine, Inc. together with PT Kalbe-Genexine Biologics (KGbio). The clinical trial process was carried out in several well-known hospitals in Indonesia and several other countries. Then, the manufacturing process for Active Pharmaceutical Ingredients (API) and finished products is carried out at PT Kalbio Global Medika. BPOM has been involved in assisting the Efesa development process since 2018, from building the production facilities for API and finished products until the product is successfully commercialized.
PT Kalbio Global Medika is currently in charge of the manufacture of Efesa from upstream to downstream, which includes the process of making API, formulation and fill-and-finish processes, up until packaging the finished product. As the only factory to produce this drug, PT Kalbio Global Medika continues to strive to improve its service and quality which makes them succeeded in obtaining several achievements, like a GMP certificate for the Efepoetin alfa biological API which is valid until 2027, and an award as the best biologics CMO in Southeast Asia (Asia Pacific Biologics CMO Excellence Awards 2023), as well as the plan to expands their manufacturing capacity to support product roll out plans outside of Indonesia.
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.
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.
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.