Press Release No. 008/KFCP-DIR/PR/II/21
Jakarta, 18 February 2021, PT Kalbe Farma Tbk ("Kalbe") through its subsidiary PT Kalbe Genexine Biologics (KGBio) signed a license agreement with Genexine South Korea to develop and commercialize an immuno-oncology drug GX-I7 (Efineptakin Alpha), namely long-acting interleukin-7 which uses the Genexine hyFc technology platform. The license agreement worth of USD 1.1 billion including an upfront payment of USD 27 million and will be followed by registration and commercialization milestones and a royalty of 10% of sales revenue. The development and commercialization license covers the Middle East, Oceania, India, Africa and all regions of Asia except China, Japan and Korea.
“The GX-I7 drug licensing agreement between KGBio and Genexine is a very strategic and important agreement for KGBIo to build a product portfolio so that it can provide innovative therapeutic products to 655 million people in Southeast Asia through Kalbe's sales and marketing network and continues to be developed in the Indian region, Oceania and the Middle East, "said Sie Djohan, President Director of PT Kalbe Genexine Biologics who is also the Director of PT Kalbe Farma Tbk," Through this license, collaboration will be built between KGBio and many global partners that will take KGBio to the next level, to become the leading biotechnology Company in Southeast Asia, "continued Djohan again.
Dr. Sung, CEO of Genexine said, "The licensing agreement with KGBio has proven that the GX-I7 product has a very high value." He continued, "Genexine will continue to actively collaborate with global partners to prove that the drug GX-I7 is recognized as an innovative immuno-oncology drug."
In addition to the GX-I7 clinical trial which was conducted as an immuno-oncology drug, KGBio is also conducting a phase-2 clinical trial for the Covid-19 drug in Indonesia with the hope of reducing the risk of Covid-19 patients to a more severe condition. Previously, KGBio had received approval for the implementation of clinical trials (PPUK) from the Indonesian Food and Drug Supervisory Agency (BPOM). GX-I7 is the only long-acting interleukin-7 under development in the world that can increase the absolute lymphocyte count. This increase in the number of lymphocytes by GX-I7 can prevent the worsening of the condition of mild or asymptomatic COVID-19 patients, especially in vulnerable populations such as the elderly by activating T-cells and the immune system in the early stages of COVID-19 infection. In addition, KGBio also plans to do a combination clinical trial of GX-I7 with anti-PD1 HLX10 to increase and expand the value of the overall pipeline.
At the end of January 2021, KGBio has also received investment from General Atlantic, a global financial investor company from the United States of US $ 55 million as primary capital to KGBIo.
In 2016, KGBio was licensed for long-acting erythropoietin GX-E4 (Efepoetin alfa) from Genexine for anemia therapy, and is currently conducting phase 3 clinical trials in Australia, Taiwan and ASEAN. In 2019, KGBio also signed a license agreement with Henlius (HK 2696), a subsidiary of Fosun Pharma, with a value of USD 692 million, and added HLX10 immune checkpoint inhibitor to its portfolio.
About Kalbe Genexine Biologics
Founded in 2016 as a joint venture between Kalbe Farma Tbk (IDX: KLBF), the largest pharmaceutical company in Indonesia and Southeast Asia, and Genexine (KOSDAQ: 095700), a biotech company in 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 licensed two advanced clinical-stage biological drugs (PD-1 for various oncology indications, and a third-generation Erythropoietin for CKD-induced anemia) and one early clinical-stage novel biological drug. A brief explanation as below:
• PD-1 Antibody (HLX10): HLX10 is a humanized anti-PD1 monoclonal antibody. It is being evaluated for the treatment of multiple tumor indications, as well as chronic hepatitis B infections. KGBio has taken licenses for squamous non-small-cell lung cancer and hepatocellular carcinoma indications in which global phase III studies are in progress.
• EPO hyFc (GX-E4): GX-E4 is a novel long-acting erythropoietin-hybrid Fc fusion protein. It is being evaluated in a phase III study for the treatment of anemia related to chronic kidney disease in Southeast Asian countries, Taiwan, and Australia.
• CD73 Antibody (TJD5): TJD5 is a CD73-antagonistic antibody. CD73 is the rate-limiting enzyme that converts extracellular AMP to adenosine, a potent immunosuppressive molecule in the tumor micro-environment. TJD5 is being evaluated in a phase I study in combination with Atezolizumab.
KGBio fully owns Innogene Kalbiotech (“Innogene”) and holds a controlling stake in Kalbio Global Medika (“Kalbio”). Innogene is a biosimilar platform and currently has four monoclonal antibody drugs (Rituximab, Nimotuzumab, Trastuzumab, and Bevacizumab).
Genexine, Inc., registered with KOSDAQ (095700) since 2009, is a company engaged in biotherapeutics with a focus on immuno-oncology and rare diseases. Genexine already has a strong product portfolio with a number of products at the clinical stage, e.g. Hyleukin-7 ™, HyTropin (GX-H9), Papitrol (GX-188E), etc, based on the “long-acting Fc fusion technology” platform and therapeutic DNA vaccine technology. Genexine has successfully completed its Phase II clinical trials and is preparing Phase III of HyTropin (long-acting human growth hormone, hGH-hyFc). Papitrol, a therapeutic DNA vaccine for HPV-associated diseases, is currently in phase II in Europe and Korea for cervical cancer (CIN) II / III. Founded in 1999, Genexine employs approximately 180 employees, with more than 50% of researchers with an MSc, or Ph.D. Genexine is based in Pangyo Techno Valley, near Seoul, Korea.
For more information, please visit the website: www.genexine.com
About Kalbe Farma
PT Kalbe Farma Tbk (“Kalbe”) was founded in 1966 and is one of the largest publicly listed pharmaceutical companies in Southeast Asia. Kalbe has four main divisions that handle a reliable and diverse brand portfolio; prescription drugs division); health product division that handles over-the-counter drugs (Promag, Mixagrip, Komix, Woods, Fatigon, etc.), multivitamins (Fatigon, H2, XonCe, Hevit-C, JossC1000 etc.), and supplement and ready-to-drink drinks (Hydro Coco, Extra Joss), the nutrition division (ChilKid, Prenagen, Diabetasol, Zee, etc.); and distribution division. Kalbe currently has more than 42 subsidiaries and 16 production facilities with international standards, and employs approximately 16,000 employees, spread across 76 branches throughout Indonesia. Since 1991, Kalbe's shares have been listed on the Indonesia Stock Exchange (IDX: KLBF).
For more information about PT Kalbe Farma Tbk, please visit www.kalbe.co.id