Kalbe Launches Anemia Drug Efepoetin Alfa for Chronic Kidney Disease Patients

Ms. Yuniar Linda, Director of KGbio said: "The launch of Efepoetin Alfa is part of Kalbe's commitment in expanding access to health for the people of Indonesia, especially for chronic kidney disease patients with anemia complications. We are also proud that Efepoetin Alfa is the first anemia drug to be researched and produced in Indonesia. This is in line with our efforts to support the government's mission of national health independence and resilience.



On the same occasion, President Director of PT Finusolprima Farma Internasional, Mrs. Liliana Susilowati, revealed that Efepoetin Alfa is expected to offer wider benefits related to anemia management in chronic kidney disease patients. "Efepoetin Alfa is a biotechnology product development innovation that is carried out continuously by Kalbe and its subsidiaries in providing optimal therapeutic options. In addition, we hope Efepoetin Alfa can improve patient comfort and compliance with treatment regimens."



As is known, the kidneys play a role in producing the hormone erythropoietin (EPO), which functions to stimulate the bone marrow to produce red blood cells. This is important for maintaining a healthy body. However, when a person has chronic kidney disease, their kidneys cannot produce enough EPO, resulting in reduced red blood cell production and anemia.



Anemia is a frequent complication in the intermediate and advanced stages of chronic kidney disease, and the condition can worsen as kidney function declines until it reaches renal failure. In this case, Efepoetin Alfa plays an important role as a long-acting erythropoiesis-stimulating agent (ESA) anemia drug. Efepoetin Alfa offers the advantage of a long half-life thanks to hybrid Fc technology from IgG4 and IgD.



"Based on phase 3 clinical trials, Efepoetin Alfa is proven to be effective, safe, and can be an alternative anemia treatment for predialysis patients. Early use of Efepoetin Alfa in predialysis patients can slow the progression of chronic kidney disease towards hemodialysis. From the patient's perspective, the use of long-acting ESA is more convenient because the injection is only 1-2 times a month," said Dr. dr. Pringgodigdo Nugroho, Sp.PD-KGH, Chairman of the Indonesian Nephrology Association (PERNEFRI).



The safety and efficacy of Efepoetin Alfa have been proven through global clinical trials conducted in Indonesia, Australia, Taiwan, Thailand, Malaysia, Philippines, and South Korea. These clinical trials involved 391 predialysis chronic kidney disease patients and showed that Efepoetin Alfa is effective in improving, maintaining, and stabilizing hemoglobin levels, as well as providing good tolerance when compared to Methoxy Polyethylene Glycol-Epoetin Beta. This stability of hemoglobin levels also helps in stabilizing the treatment dose.



Overview of Kalbe

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 that handle a reliable and diverse brand portfolio; prescription pharmaceuticals division, health products division that handles over-the-counter drugs and multivitamins, nutrition division; and distribution & logistics division.



Kalbe has also developed a B2B digital services ecosystem, namely EMOS and MOSTRANS. EMOS is an order management application system that enables distribution channels to perform stock management or supply chain. MOSTRANS is a B2B transportation solution provider to provide ease of transportation management and efficiency.



Kalbe currently has more than 40 subsidiaries and 15 production facilities with international standards, and is supported by approximately 16,000 employees, spread across 72 branches throughout Indonesia. Since 1991, Kalbe's shares have been listed on the Indonesia Stock Exchange (IDX:KLBF).



Overview of Kalbe Genexine Biologics

KGbio is a clinical-stage biotechnology company established in 2016, focused on bringing biological medical innovations to markets outside the US/Canada, Western Europe and China. Its business model involves licensing certain novel and biosimilar biologics in oncology and specialty therapeutic areas (typically pre-IND or early clinical stage), with the aim to license them in target geographies upon completion of clinical development as well as regulatory approval.



Platforms of interest include Fc-fusion proteins, antibodies, bispecifics, ADCs, cell therapies and therapeutic vaccines. The company is backed by Asian pharmaceutical company PT Kalbe Farma Tbk, Genexine, and US private equity firm General Atlantic.