KALBE RECEIVES MARKET APPROVAL FOR ANEMIA TREATMENT - EFEPOETIN ALFA BY INDONESIAN MINISTRY OF FOOD AND DRUG SAFETY

PRESS RELEASE No. 68/KFCP-DIR/PR/X/23 Jakarta, 23 October 2023,  PT Kalbe Farma Tbk (Kalbe) through its subsidiary Kalbe-Genexine Biologics (KGbio) receives market approval by the Indonesian Ministry of Food and Drug Safety (BPOM  for Efepoetin alfa, the first anemia treatment developed and produced in Indonesia-.  Efepoetin alfa (EPO-HyFc, GXE4) is the product  for the treatment of Chronic Kidney Disease (CKD). “Kalbe believes that obtaining BPOM approval for anemia treatment Efepoetin alfa, will significantly improve patients’ access to medicines that are vital for their recovery, “ said President Director PT Kalbe Genexine Biologics Sie Djohan. Sie Djohan said the anemia treatment- Ephepoetin Alfa has gone through phase 3 clinical trials in 7 countries namely Indonesia, Australia, Taiwan, the Philippines, Thailand, and Malaysia and Korea. Genexine and KG Bio have also initiated a large Phase 3 clinical trial targeting dialysis patients with CKD. This study is being conducted in Europe and Asia and will support the label expansion to capture both the dialysis and non-dialysis patient market. “We are thrilled to have our first ever product approval,” said Neil Warma, President and CEO of Genexine. “This is a landmark result for everyone at Genexine and our partner KG Bio and represents not only our first market approval but one of the first ever of a therapeutic discovered, developed and commercialized by a Korean BioPharma company. Our efforts to focus on commercialization over the past year have been successful and we now look to roll out this product in several other Asian countries and expand the indication to include dialysis patients. Efepoetin alfa was one of the products developed using our proprietary hyFc® fusion platform and demonstrates our ability to deliver a best-in-class drug to patients suffering from CKD-induced anemia.” Interim results which presented by KG Bio in April 2023, demonstrated non-inferiority to control product including good safety and tolerability, meeting the primary endpoint with a response rate in patients whose hemoglobin level increased by more than 1g/dL was 69.6,. 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 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, kindly visit: www. https://www.kg-biologics.com/ About Genexine 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. 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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