shanghai henlius obtained third monoclonal antibody drug approval-- a biosimilar version of trastuzumab
on 16 july, shanghai henlius biotech company limited (“shanghaihenlius”), a corporation controlled by fosun pharmaceutical, officiallyreceived the third clinical trial approval issued by china food and drugadministration for the recombinant humanized anti-her2 monoclonalantibody under shanghai henlius, which has been developed specifically forindications for breast cancer, and belongs to the biosimilar version oftrastuzumab.
trastuzumab was the first monoclonal antibody approved by fdain 1998 for the treatment of her2 metastatic/early stage breast cancer, and itcan also be used by combination of chemotherapy drugs. the drug was imported tochina in 2002, with the brand name herceptin®. according to roche’s salesvolume of the product in 2014, only over 6,000 patients in china could affordthe expense of the drug in a year. however, partly estimated, 45,000 patientswith breast cancer are in need of the drug, which means that 85% of thepatients cannot receive appropriate medical treatment due tofinancial reasons. therefore, it is urgent for high-quality whilelow-cost domestic monoclonal antibody drugs to come into the market.
obtaining the approval of the third clinical trial couldbring relief to millions of patients with breast cancer in china. and shanghaihenlius will continue to independently research and manufacture high-quality monoclonalantibody drugs through existing technology and platforms.
as a research and development platform of fosunpharmaceutical for macromolecular generic biopharmaceutical drug, shanghaihenlius has been adhering to the r&d principles of prioritizing efficacyand efficiency by upholding international standards and implementing itsr&d strategy of developing biological macromolecular drugs over the past 5years. reportedly, shanghai henlius has by far completed theregistrations of clinical applications for five categories of monoclonalantibodies and seven types of indications, in addition to seven innovative monoclonalantibodies in the pipeline of r&d product line.
all products of shanghai henlius currently under developmentare in fact the achievements of its in-house and multinational r&d team,and the various world-class r&d platforms for monoclonal antibodiescovering a full spectrum of relevant technologies established by shanghaihenlius set ground for such achievements. these platforms range from phagedisplay libraries, antibody engineering, bispecific antibody platform, internaland external pharmacodynamics evaluation systems to development for themethodologies of quality analysis and structure validation, process developmentfor products and pilot production in line with gmp standards.
as always, independent innovation remains the driving force forcorporate development at fosun pharmaceutical. the company continues to focuson its innovative r&d while optimizing its innovative r&d system formedicine that integrates imitation and innovation. meanwhile, fosunpharmaceutical is highly supportive of innovative r&d and committed tolaunching new products by constantly increasing investment in r&d platforms.the company is a national-level enterprise technology center with highlyefficient international r&d teams in shanghai, chongqing and the us.