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Kalbe Genexine Biologics Enters Into an Exclusive Licensing of Immuno-Oncology Product with Henlius of China

Kalbe Genexine Biologics Enters Into an Exclusive Licensing of Immuno-Oncology Product with Henlius of China

Press Release No.  036/KFCP-DIR/PR/IX/19

Jakarta, 16 September 2019 – PT Kalbe Genexine Biologics (KG Bio), a joint venture of Kalbe Farma Tbk (Kalbe), and Genexine, Inc. enters into an exclusive collaboration for HLX10 an immuno-oncology product developed by Shanghai Henlius Biotech, Inc of China. HLX10 is a recombinant humanized anti-programmed cell death (PD-1) monoclonal antibody injection independently developed by Henlius. With the collaboration, KG Bio will be granted exclusive rights to develop and commercialize HLX10 in the South East Asia including Philippines, Indonesia, Malaysia, Singapore, Thailand, Laos, Myanmar, Cambodia, Brunei and Vietnam.

”We welcome warmly this collaboration with Henlius, through this we will be able to enrich the product portfolio of KG Bio in the field of immune-oncology. This collaboration of Kalbe with Henlius through KG Bio has the potential to drive the development of innovative biologics that are both high quality and affordable in Indonesia and South East Asia,” commented Sie Djohan, Director of PT Kalbe Farma Tbk and President Commissioner of PT Kalbe Genexine Biologics, Inc.,

“We are excited to achieve the collaboration on HLX10 and look forward to working with the experienced team at KG Bio and Kalbe. Their extensive sales networking and in-depth coverage in Southeast Asian Market will undoubtedly fuel the globalization of the development and commercialization for HLX10 in the market. There have been exponential gains in immuno-oncology in recent years through the development of immune checkpoint inhibitors such as anti-PD-1 and anti-PD-L1. However, not all patients benefit, and efforts should thus focus on improving the efficacy of immunotherapy through the use of combination approaches. Against such a backdrop, we differentiate ourselves with ‘Global plus Combo’ strategy. For ‘Combo’, we mean we advance immuno-oncology combination therapies with proprietary mAbs as backbones in combination with other therapies. For ‘Global’, we have global multi-center clinical trials ongoing in various countries and regions worldwide. We believe the collaboration will further strengthen the globalization of our immuno-oncology combination therapy,” commented Scott Liu, Ph.D., the Co-Founder, President, and Chief Executive Officer of Henlius.

About Kalbe Genexine Biologics (KG Bio)
KG Bio is a joint venture between Kalbe Farma of Indonesia and Genexine of South Korea. KG bio is focused on clinical development and the commercialization of novel biologics and monoclonal antibodies in ASEAN, Asia Pacific and MENA. Through innovative technological platform that ensures affordable and high-quality products, KG Bio aims to provide innovative biologic and immuno-oncology products, and better solutions in treating human diseases.

About Kalbe
PT Kalbe Farma Tbk was established in 1966 and is one of the largest publicly-listed pharmaceutical companies in Southeast Asia. It has four main divisions include prescription pharmaceuticals, consumer health, nutritionals and distribution with over one million outlets. Kalbe Farma currently has more than 35 subsidiaries and 12 production facilities with international standards, supported by around 17,000 employees, spread in 76 branches across Indonesia. Since 1991, its shares have been listed on the Indonesia Stock Exchange (IDX: KLBF)

About Genexine, Inc.
Genexine, Inc., listed on KOSDAQ (095700) since 2009, is a leading biotherapeutics company focused on immuno-oncology and orphan disease. Genexine has a robust pipeline of products in the clinical stage, e.g. Hyleukin-7™, HyTropin (GX-H9), Papitrol (GX-188E), etc. based on long-acting Fc fusion technology and therapeutic DNA vaccine technology. Genexine has completed multinational phase II trials and is preparing to apply IND of US Phase III trial for HyTropin (long-acting human growth hormone, hGH-hyFc). Papitrol, a therapeutic DNA vaccine for HPV-associated diseases, is under Phase II in Europe and Korea for Cervical Intraepithelial Neoplasia (CIN) II/III. Founded in 1999, Genexine has over 180 employees, and half of them are scientists with MSc, or Ph.D. Genexine is located in Pangyo Techno Valley near Seoul, Korea.

About Henlius
Henlius is a leading biopharmaceutical company in China with the vision to offer high-quality, affordable and innovative biologics for patients worldwide with a focus on oncology and autoimmune diseases. Since its inception in 2010, Henlius has built an integrated and efficient global R&D platform with key facilities in Shanghai, Taipei and California. The three R&D centers closely collaborate with each other to ensure a highly productive and cost-efficient R&D process. Starting from biosimilar, Henlius presses forward with novel mAb products and immuno-oncology combination therapies with proprietary anti-PD-1 and PD-L1 mAbs as backbone. Henlius establishes a diversified product pipeline of biosimilars, bio-innovative drugs and combination therapies, and builds an integrated platform covering the whole product lifecycle including R&D, commercial-scale production and commercialization.

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