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Kalbe Develop Patent Bio Technology Medicine: Global Phase 3 Clinical Trial - Ephepoetin Alpha For Therapy Of Anemia In Chronic Kidney Disease

Kalbe Develop Patent Bio Technology Medicine: Global Phase 3 Clinical Trial - Ephepoetin Alpha For Therapy Of Anemia In Chronic Kidney Disease

Jakarta, January 24, 2020, PT Kalbe Farma Tbk (Kalbe) through its subsidiary Kalbe-Genexine Biologics developed the patent biotechnology drug Ephepoetin Alpha (EPO-HyFc), which is a drug used to treat anemia in chronic kidney patients. At present the development of the drug Ephepoetin Alpha has entered the clinical trial phase 3 to test whether the drug has been effective and is safe to use. Furthermore, the Food and Drug Supervisory Agency is also overseeing the phase 3 clinical trial process to be the basis for the distribution permit.This was announced by Penny K. Lukito, Head of the POM Agency and accompanied by Irawati Setiady, President Commissioner of PT Kalbe Farma Tbk in a press conference held in Jakarta today.

"The Phase 3 clinical trial on the Ephepoetin Alpha is a very gratifying step forward for the pharmaceutical world in Indonesia," said Penny K. Lukito, Head of POM, "We truly appreciate the steps of Kalbe Group that continues to innovate and be productive in conducting research including developing drugs using high technology such as biotechnology products," she added.

"We are grateful for the support of the National Drug and Food Control Agency for what Kalbe is conducting in phase 3 clinical trial process of this biotechnology drug," said Irawati Setiady, President Commissioner of PT Kalbe Farma Tbk, "Kalbe hopes that this research can initiate more research for new drugs that will contribute to improving public health in Indonesia." She continued.

Phase 3 clinical trials that is conducted globally with products manufactured in Indonesia through PT Kalbio Global Medika (KGM) will involve 386 subjects from 50 institutions in 6 countries, i.e. Indonesia, Australia, Taiwan, the Philippines, Thailand, and Malaysia. The Ephepoetin Alpha (EPO-HyFc) drug itself has completed the pre-clinical trials, phase 1 clinical trials, and phase 2 trials with internationally recognized results.

PT Kalbe Farma Tbk is known to have a cooperation with a South Korean biological drug company, Genexine Inc. in developing and making raw materials for biotechnology medicines. Both pharmaceutical companies that are strong in the fields of research and innovation together have established the company, PT Kalbe Genexine Biologics (KGBio), in Indonesia.

For illustration, the clinical trial phases that must be passed in the process of developing a patent medicine are: Pre Clinical; Phase I clinical trial that were performed on healthy humans, aiming to determine a safe dose range; Phase 2 clinical trial, conducted on a limited number of sufferers to see whether the pharmacological effects as seen in phase I are useful or not for treatment; Phase III clinical trial that is conducted on patients with the aim to ensure that a new drug really has effectiveness and is safe to use; and Phase IV clinical trial that will be the observations of the marketed drug.

PT Kalbe Genexine Biologics at a glance

PT Kalbe Genexine Biologics, established in 2016, is a joint venture between PT Kalbe Farma Tbk and Genexine Inc. of South Korea. Kalbe Genexine Biologics holds the purpose of development of innovative- and biotechnology-based drugs, with focus on the design of clinical and non-clinical trials, the CMC development process, and meeting established regulations and quality. At present the company is developing EPO hyFc products: Genexine's 3rd generation long-acting EPO and PD-1: HLX10 licensed in from Henlius Biotech.

Kalbe at a glance

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 reliable and varied brand portfolio: prescription medicines (Cefspan, Brainact, Broadced, etc.); over-the-counter medication division (Promag, Mixagrip, Komix, Woods, Fatigon, etc.); energy and ready-to-consume drinks (Hydro Coco, Extra Joss, Nitros); nutrition division (ChilKid, Prenagen, Diabetasol, etc.); and distribution and logistics division.Kalbe currently has approximately 35 subsidiaries and 12 production facilities with international standard, and employs approximately 17,000 employees dispersed across more than 74 branches throughout Indonesia. Since 1991, Kalbe has been listed at the Indonesia Stock Exchange, with ticker code: KLBF.

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