PT Kalbe Farma Tbk : KALBE Hit The Target Numbers of Patients in Phase 3 Clinical Trial with Its Proprietary Long-acting Anemia Treatment, GX-E4 (Efepoetin alfa)

KALBE Hit The Target Numbers of Patients in Phase 3 Clinical Trial with Its Proprietary Long-acting Anemia Treatment, GX-E4 (Efepoetin alfa)

PRESS RELEASE No. 041/KFCP-DIR/PR/VI/22

Jakarta, 27 Juni 2022, PT Kalbe Farma Tbk (Kalbe) through its subsidiary Kalbe-Genexine Biologics (KGBio) hit the target numbers of patients in Phase 3 clinical trial with its proprietary long-acting anemia treatment, GX-E4 (Efepoetin alfa). However there are still a few patients in the screening and need to random them if they are eligible. Efepoetin Alpha (EPO-HyFc, GXE4) is one of medicinal products Efepoetin Alpha developed from the HyFc platform for anemia patients with chronic kidney disease

"We have achieved the intended target numbers of 386 patients from seven different countries/regions such as Indonesia, Australia, Taiwan, the Philipines, Thailand, Malaysia, and South Korea. We hope that this result could accelerate the GXE4 product commercialization process in both ASEAN territories and other Asian countries," said Sie Djohan, the President Director of PT Kalbe Genexine Biologics.

In this phase 3 clinical trial, which was conducted for the treatment of anemia in non-dialysis chronic kidney disease patients from multiple countries and ethnicities, KG Bio plans to verify non-inferiority compared to the Mircera control group in the open-label, randomized trial. The company focus on starting the approval process for non-dialysis patients as soon as the phase 3 data is available.

CEO of Genexine Neil Warma said that the development process for the commercialization of GX-E4 is proceeding smoothly including the recruitment of global clinical patients.

"We believe GX-E4 is well-differentiated and should be positioned strongly in the market. Our hyFc○R platform provides us with a cost-effective method for manufacturing our drug products, including GX-E4, and we believe we should be able to enter the market at a competitive price," Said Neil Warma.

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.

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. ("Genexine") is a publicly traded, clinical-stage biotechnology company focused on the development and commercialization of immunotherapeutics and next-generation long-acting biologics. Its primary technology platforms are Therapeutic DNA vaccine technology and hyFc® fusion technology. Genexine has multiple products clinical development including several undergoing Phase 3 registration trials. Genexine's proprietary pipeline includes GX-188 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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