Henlius (2696.HK) 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 entered into an Exclusive License Agreement for HLX10 – a recombinant humanized anti-programmed cell death (PD-1) monoclonal antibody (mAb) injection independently developed by Henlius. With the collaboration, KG Bio will be granted exclusive rights to develop and commercialize HLX10 in relation to (i) the first monotherapy for the treatment of solid tumour (MSI-high) (ii) the two combination therapies and (iii) two new indications KG Bio may in license in accordance with the Agreement in the Asia Pacific territory including the Philippines, Indonesia, Malaysia, Singapore, Thailand, Laos, Myanmar, Cambodia, Brunei and Vietnam. The estimated maximum payment may reach the total value of US$ 692 million including 1) non-creditable payment of US$10 million; 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 and performed by Henlius.
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. Moreover, the overall population of Southeast Asia hits 650 million, which translates into significant unmet needs. With the long-term commitment to "affordable innovation", through the collaboration, Henlius will also provide patients in Southeast Asia access to high-quality, affordable and novel biological therapies.
The collaboration also further strengthens the globalization of its immuno-oncology combination therapy in Southeast Asia. Although Anti-PD-1 mAb, as a broad-spectrum immunosuppressant, can be widely applied in the immunotherapy of cancer, it shows low efficacy as mono-therapy. Henlius thus adopts “Combo plus Global” strategy to differentiate its immuno-oncology combination therapy strategy with proprietary mAbs including HLX10 and HLX20 (anti-PD-L1 mAb) as backbones in combination with other therapies and with global multi-center clinical trials ongoing in various countries and regions worldwide.
Looking into the future, 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.
Henlius（2696.HK）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. On September 25, 2019, Henlius was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 2696.HK.
Until now, in addition to one product launched commercially, two products under New Drug Application (NDA) review and one product under Marketing Authorization Application (MAA) review, Henlius has conducted over 20 clinical studies for 14 products and 6 combination therapies worldwide. HLX01 (汉利康®, rituximab injection), the first product of Henlius, has been granted approval by the NMPA as the first approved biosimilar in China. HLX03 (adalimumab injection) and HLX02 (trastuzumab for injection) 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 chemotherapy and other mAbs including HLX04 (bevacizumab biosimilar). 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.