Kalbe Adds South Korea for Ohase 3 of Clinical Trials of Anemia Medicine Ephepoetin Alpha

Jakarta, April 5, 2021, PT Kalbe Farma Tbk (Kalbe) through its subsidiary Kalbe-Genexine Biologics (KGBio) is accelerating the phase 3 clinical trials for the Ephepoetin Alpha (EPO-HyFc) for anemia therapy on non-dialysis chronic kidney patients by adding another country, South Korea. With the approval of phase 3 clinical trials in South Korea, the number of countries involved in clinical trials of the drug Efepoetin Alfa (EPO-HyFc, GXE4) will increase to 7 countries including Indonesia, Australia, Taiwan, the Philippines, Thailand and Malaysia. "The Covid-19 pandemic has caused the clinical trial process to experience challenges in patient recruitment, with the opening of one more country we are confident that we will be able to mitigate the risk of disruption of this pandemic to phase 3 of the clinical trials," said Sie Djohan, President Director of PT Kalbe Genexine Biologics, "Efepoetin Alpha (EPO-HyFc, GXE4) is one of the main medicinal products developed from the HyFc platform which has passed pre-clinical trials, phase-1 clinical trials and phase 2 clinical trials for anemia patients with chronic kidney disease. " Kalbe-Genexine Biologics (KGBio) is a joint venture company between PT Kalbe Farma Tbk (Jakarta, Indonesia) and Genexine Inc. (Seoul, South Korea) which was established in January 2016 to develop products based on biotechnology. The implementation of Phase 3 clinical trial in South Korea will be part of the product development of Efepoetin alpha (EPO-HyFc, GXE4), which has entered into a phase 3 clinical study with an open, randomized, and “multi-center” design (protocol No. GXE4KGBio-001 ) with the name of research Helios. This study aims to determine whether Efepoetin alfa is effective and well tolerated compared to Mircera (methoxy polyethylene glycol - epoetin beta) - for the treatment of non-dialysis chronic kidney disease patients.  Helios is a non-inferior study that includes CKD patients who have never been treated and CKD patients who are treated with ESA and are not on dialysis. Details of the study can be accessed through the link http://www/clinicaltrials.gov (NCT04155125). About Kalbe Genexine Biologics Established in 2016 as a joint venture between Kalbe Farma Tbk (IDX: KLBF), the largest pharmaceutical company in Indonesia and Southeast Asia; with Genexine (KOSDAQ: 095 700), a biotechnology company from South Korea. KGBio has a vision to provide high quality and affordable innovative biological, biosimilar and immuno-oncology products for the Southeast Asian market. KGBio has the license to perform two advanced clinical trials (PD-1 for various oncology indications, and 3rd generation Erythropoietin for CKD-induced anemia) and an initial clinical trials (early stage). A brief explanation as below: • PD-1 Antibody (HLX10): HLX10 is a humanized anti-PD1 monoclonal antibody.  It is currently being tested for the treatment of multiple tumor indications and chronic hepatitis B infection. KGBio has also received approval for phase III clinical trials globally and is currently still ongoing.  • EPO hyFc (GX-E4): GX-E4 is a novel long-acting erythropoietin-hybrid Fc fusion protein. Currently, phase III clinical trials are being carried out for the treatment of anemia for chronic kidney patients in Southeast Asian countries, Taiwan and Australia. • CD73 Antibody (TJD5): TJD5 is the CD73-antagonistic antibody. CD73 is the rate-limiting enzyme that converts the extracellular AMP to adenosine, a potent immunosuppressive molecule in the tumor micro-environment. Currently TJD5 is being evaluated in a phase I clinical study in combination with Atezolizumab. KGBio also has a subsidiary, Innogene Kalbiotech (“Innogene”), and is a controlling shareholder of Kalbio Global Medika (“Kalbio”). Innogene is a company with biosimilar platform products, i.e. four monoclonal antibody drugs (Rituximab, Nimotuzumab, Trastuzumab, and Bevacizumab). Whereas Kalbio is a biological product manufacturing facility with the capacity of the bioreactor for mammalian cell lines.  For more information, visit: www. https://www.kg-biologics.com/ About Genexine Genexine, Inc., registered with KOSDAQ (095700) since 2009, is a biotherapeutics company that focuses on immuno-oncology and orphan disease. Genexine has strong pipeline products for the clinical stages, for example: Hyleukin-7, HyTropin (GX-H9), Papitrol-188 (GX-188E) based on the long-acting Fc Fusion technology and therapeutic DNA vaccine technology. Genexine has completed testing of multi-national Phase II and is preparing to file IND clinical trial Phase-3 in the United States for HyTropin (human growth hormone long labor, hGH-HYFC), Papitrol-188, a DNA vaccine therapeutic that is currently in clinical trial phase -2 in Europe and Korea for Cervical Intraepithelial Neoplasia (CIN) II / III.  Founded in 1999, Genexine has more than 140 employees, most of whom are scientists with MSc, or Ph.D. degrees. Genexine is located in Pangyo Techno Valley near Seoul, Korea. About PT Kalbe Farma Tbk PT Kalbe Farma Tbk ("Kalbe") was established in 1966 and is one of the largest listed pharmaceutical companies in Southeast Asia. Kalbe has four main divisions that handle a reliable and diverse portfolio of brands; the prescription drugs division, the health products division that handles over-the-counter drugs and energy and ready-to-drink drinks, the nutrition division, and the distribution division. Kalbe currently has approximately 40 subsidiaries and 14 production facilities with international standard, and employs approximately 17,000 employees dispersed across more than 76 branches throughout Indonesia. From 1991, Kalbe is listed on the Indonesia Stock Exchange (IDX: KLBF).

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