Through its subsidiaries of PT Kalbe Genexine Biologics (KGbio) and PT Finusolprima Farma Internasional (FIMA), PT Kalbe Farma Tbk (Kalbe) launches the Efepoetin Alfa drug, which is indicated as a means of anemia therapy for patients with chronic kidney diseases. The launching of this drug is the continuity of Kalbe and their subsidiaries’ actions after they secured the distribution license from the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan RI/Badan POM) in October 2023.
“The launching of Efepoetin Alfa is a part of Kalbe’s commitment in extending our reach towards providing healthcare access for Indonesians, especially for patients with chronic kidney diseases who experience anemia. We take pride of this because Efepoetin Alfa is the first anemia drug that was researched and produced in Indonesia. This is in line with our effort in supporting the government’s mission in relations to the independence and resilience of national health,” says the Director of KGbio, Yuniar Linda.
Meanwhile, the President Director of PT Finusolprima Farma Internasional, Liliana Susilowati, has expressed that the presence of Efepoetin Alfa is expected to bring about wider range of benefits on the governance of anemia treatment for patients with chronic kidney diseases. “Efepoetin Alfa is an innovation of biotechnological products development that is being performed continuously by Kalbe and their subsidiaries to provide optimum therapy choices. Therefore, we expect that Efepoetin Alfa could improve patients’ comfort and obedience to treatment regimens.”
As people might know, our kidneys play a role in producing erythropoietin (EPO), a hormone that stimulates the bone marrow to produce red blood cells. This process is vital in maintaining our health. Thus, when someone has a chronic kidney disease, their kidneys cannot produce sufficient EPO. This in turn results in lessened red blood cell count which could trigger anemia.
Anemia is a complication that often happens during the middle or latter stages of chronic kidney diseases and can worsen as kidney functions lessen, which can result in kidney failures. In such cases, Efepoetin Alfa plays an important role as a long-acting erythropoiesis-stimulating agent (ESA) drug. Efepoetin Alfa offers a benefit which is a long half-life due to the hybrid Fc technology of IgG4 and IgD.
“According to our third phase of clinical trials, Efepoetin Alfa has proven to be effective, safe, and can be used as an alternative for anemia treatment for pre-dialysis patients. The use of Efepoetin Alfa for these patients can help delay the progression of their chronic kidney diseases towards hemodialysis. From patients’ perspectives, a long-acting ESA is more comfortable because it only requires to be injected 1-2 times per month,” states Dr. dr. Pringgodigdo Nugroho, Sp.PD-KGH, the Chairman of the Indonesian Nephrologists Association (Perhimpunan Nefrologi Indonesia/PERNEFRI).
The safety and efficacy of Efepoetin Alfa have been proven through global clinical trials that were conducted in Indonesia, Australia, Taiwan, Thailand, Malaysia, the Philippines, and South Korea. These clinical trials involved 391 patients in pre-dialysis chronic kidney diseases and showed that Efepoetin Alfa was effective in repairing, maintaining, and stabilizing hemoglobin level, plus showing a good tolerance when being compared to Methoxy Polyethylene Glycol-Epoetin Beta. This stable hemoglobin level was also helpful in stabilizing the dosage of treatments.
About KGbio
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.
About Kalbe
PT Kalbe Farma Tbk (Kalbe) was established in 1966 and is one of the biggest public pharmaceutical companies in Southeast Asia. Kalbe has four main divisions that handle a portfolio of dependable and various brands: the prescription pharmaceutical division, the health products division that handles over-the-counter drugs, multivitamins, and ready-to-serve supplemental drinks, the nutritions division, and the distribution & logistics division.
Kalbe has also developed a B2B-based digital services ecosystem for the society: EMOS and KlikDokter, a B2C service. EMOS is an order management application system that helps distribution channels perform their stock or supply chain management actions. KlikDokter is a digital platform for healthcare services focusing on telemedicine, which provides health consultation and products that are needed by the society.
Kalbe now has more than 40 subsidiaries and 15 international-standard production facilities, supported by around 16,000 employees in 76 branches throughout Indonesia. Kalbe’s shares have been listed in Indonesia Stock Exchange/Bursa Efek Indonesia (IDX:KLBF) since 1991.
Reference: