Shanghai Henlius Obtained the Clinical Approval for the Fifth Monoclonal Antibody Drugs by China Food and Drug Administration (CFDA)
It was announced by Fosun Pharmaceutical (Group) Co., Ltd (“Fosun Pharma”) on 21st Jan 2016 that the “Recombinant Anti-TNFα Humanized Monoclonal Antibody Injection” developed by Shanghai Henlius, a subsidiary of Fosun Pharma that focuses on the development, production and commercialization of monoclonal antibody drugs , received the clinical trial approval by China Food and Drug Administration for the treatment of rheumatoid arthritis.
To date, Shanghai Henlius has reportedly obtained five clinical trial approvals. The “Recombinant Anti-TNFα Humanized Monoclonal Antibody Injection” which is used in the treatment of rheumatoid arthritis, is a monoclonal antibody biosimilar independently developed by Shanghai Henlius. The scale-up of the pilot production process for this drug has been completed, and it has been proved that the antibody is highly similar to its original version of Adalimumab (brand name Humira®,manufactured by AbbVie) through dozens of quality testsin terms of physicochemical properties, biological activity, in vitro/in vivo efficacy, drug metabolism and toxicology data, etc.
Independent innovation has always been the driving force for corporate development at Fosun Pharma. The company continues to optimize its innovative R&D capability that integrates imitation and innovation, and has established highly efficient international R&D teams in Shanghai, Chongqing, San Francisco and Taipei. Meanwhile, Fosun Pharma is committed to launching new products by constantly increasing investment on its R & D platforms. The unique “4+1” R&D platform of Fosun Pharma, specializes in the small molecule chemistry innovative drugs, macromolecular biological generic drugs, specialized formulations, and difficult generic drugs, and has taken the initiatives to keep up with cutting-edge technology of the global pharmaceutical industry. Shanghai Henlius, adhering to its core philosophy of “quality, speed and innovation”, will continue to build itself into a trusted and leading biopharmaceutical company in China with a significant global impact.