Shanghai, China, December 5, 2019 – Shanghai Henlius Biotech, Inc. (2696.HK) today announced that the Company has recently entered into an exclusive license agreement with FARMA DE COLOMBIA S.A.S (“FARMA DE COLOMBIA”) pursuant to which FARMA DE COLOMBIA has been granted exclusive licensing and commercialisation rights of HLX01 in Colombia, Peru, Ecuador and Venezuela.
HLX01 (Rituximab Injection, Brand Name: 汉利康®) received NDA approval for commercialisation from the NMPA on February 22, 2019 for the non-Hodgkin lymphoma indication, becoming the first biosimilar drug approved and commercially launched in China in accordance with the Biosimilar Guidelines. HLX01 has been included in the National Essential Drug List (NEDL) and the National Reimbursement Drug List (NRDL). The Company is also conducting a Phase 3 clinical trial for the rheumatoid arthritis indication for HLX01 in China.
Prior to this, Henlius and Biosidus S.A. (“Biosidus”), an Argentina-based company, has established an alliance whereby Biosidus is exclusively authorized to develop and commercialize HLX01, in certain emerging countries in Latin America. Moreover, Henlius has reached a combination therapy strategic collaboration with Ascentage Pharma (6855.HK), working together to conduct clinical trials of the combination therapy between HLX01 and APG-2575, a novel, orally administered Bcl-2 selective inhibitor developed by Ascentage Pharma, for the treatment of chronic lymphocytic leukemia (CLL) in China.
Leveraging the extensive commercial network of FARMA DE COLOMBIA in certain markets of the America, Henlius will accelerate HLX01’s globalization to fulfill the unmet healthcare needs from emerging markets and to benefit more patients with China-manufactured high-quality biologics. In the future, Henlius will proactively expand its global footprint through continued strategic collaboration with global leading pharmaceutical companies to deliver high-quality and effective biologics for patients worldwide.
About Farma de Colombia
Farma de Colombia was founded in 1960 and has gained a highly regarded image among the health providers community. Farma de Colombia belongs to Candoria Holding AG (based in Zug, Switzerland), who owns, as well, subsidiaries in Ecuador, Peru and Venezuela, and commercializes its products in Central America and the Caribbean.
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.