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Henlius and KG Bio Announce a Collaboration for Henlius Novel Anti-PD-1 mAb HLX10 in the Asia Pacific Region


Shanghai Henlius Biotech, Inc., a commercial-stage biopharmaceutical company focused on developing and commercializing antibodies for the treatment of tumor and auto-immune diseases (hereinafter referred to "Henlius"), and PT Kalbe Genexine Biologics (hereinafter referred to "KG Bio"), a holding subsidiary to PT Kalbe Farma, Tbk (hereinafter referred to "Kalbe Farma"), an Indonesian pharmaceutical company, today announced a collaboration for HLX10 – 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 Asia Pacific territory including Philippines, Indonesia, Malaysia, Singapore, Thailand, Laos, Myanmar, Cambodia, Brunei and Vietnam. The payment reaches the total value of US$ 692 million including 1) upfront payment of US$10 million upon signing of the License Agreement; 2) commercial sales milestone payments not exceeding US$650 million depending on the level of accumulative net sales of relevant products; 3) regulatory milestone payments not exceeding US$22 million; 4) US$10 million to fund the trials of two combination therapies to be initiated by Henlius.

The collaboration is an important milestone of the global strategy for the expanded commercial presence of Henlius. Established in January 2016, KG Bio is a joint-venture between Kalbe Farma, one of the largest publicly-listed pharmaceutical companies in Southeast Asia and Genexine Inc. (hereinafter referred to "Genexine") of South Korea, focusing on clinical development and the commercialization of novel biologics and monoclonal antibodies in ASEAN, Asia Pacific and MENA. Benefiting from the extensive sales networking of Kalbe Farma and the innovative technology platform of Genexine, KG Bio is committed to delivering innovative biologic and immuno-oncology products, and better solutions in treating human diseases. Through the collaboration with KG Bio and Kalbe Farma, Henlius will strengthen its market access to Southeast Asia for HLX10 as a part of its international strategy through Kalbe Farma's extensive sales networking in the market with the aim of sharpening its global competitiveness and brand awareness in the field of immuno-oncology. With the long-term commitment to "affordable innovation", Henlius continues to provide patients in Southeast Asia access to high-quality, affordable and novel biological therapies.

"We are excited to achieve the collaboration on HLX10 and look forward to working with the experienced team at KG Bio and Kalbe Farma. 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.

"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 other Southeast Asian countries," commented Sie Djohan, Director of Kalbe Farma and President Commissioner of KG Bio.

Looking forward, Henlius will proactively expand its global presence through continued strategic collaboration with international leading pharmaceutical companies, underscoring its mission to deliver quality products and effective treatment to patients worldwide.

About HLX10

HLX10 (recombinant humanized anti-PD-1 monoclonal antibody injection) is a noval mAb developed by Henlius independently. Currently, the global multi-center clinical trials for the treatment of various tumors are undergoing in different countries and regions such as Taiwan China and Mainland China. Concurrently, HLX01 is also being developed for the treatment of chronic hepatitis b infection.

Combination therapy has become main trend with the aim of improving the efficacy of anti-PD-1 products as mono-therapy. By virtue of high-caliber talents and integrated R&D platform, Henlius presses forward with the strategy of immune-oncology combination therapy with proprietary mAbs including HLX10 and HLX20 (recombinant humanized anti-PD-L1 monoclonal antibody injection) as backbones, among which, the combination therapy of HLX10 plus HLX 04 (bevacizumab biosimilar), HLX07 (recombinant anti-EGFR humanized monoclonal antibody injection) and chemotherapy are indicated for squamous cell carcinoma of the head and neck (SCCHN), locally advanced or metastatic esophageal squamous cell carcinoma (mESCC), locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), metastatic non-squamous non-small cell lung cancer (nsNSCLC) , hepatocellular carcinoma (HCC) and so forth.

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.

Until now, in addition to one product launched commercially and two products under NDA/MAA review, Henlius has conducted over 20 clinical studies for 14 products and 6 combination therapies worldwide. HLX01, the first product of Henlius, has been granted approval by the NMPA as the first approved biosimilar in China. HLX03 (adalimumab injection) and HLX02 have their NDA under priority review by the NMPA. HLX02 is also the first China-manufactured biosimilar developed in a global setting. In June 2019, the MAA for HLX02 was accepted for review by EMA. Moreover, Henlius advances immuno-oncology combination therapies with proprietary mAbs including HLX10 (anti-PD-1 mAb) as backbone in combination with other mAbs including HLX04 (bevacizumab biosimilar) and HLX07 (anti-EGFR mAb). The global multi-center clinical trials are ongoing in various countries and regions worldwide.

About KG Bio

Kalbe Genexine Biologics (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 Farma

Kalbe Farma 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.