shanghai henlius obtained the fourth monoclonal antibody drug approval
on 7 january 2016, shanghai henlius biotech company limited (“shanghai henlius”), a research and development platform of fosun pharma for macromolecular biosimilars, received the fourth clinical trial approval issued by china food and drug administration for the “recombinant vegf humanized monoclonal antibody injection” with approved indication for metastatic colon cancer, which is a biosimilar of roche’s bevacizumab.
bevacizumab injection was approved by the u.s. food and drug administration for the indication for metastatic colon cancer in 2004, and later 5 other indications of which were approved for non-squamous non-small-cell lung cancer, glioblastoma, metastatic renal cell carcinoma, ovarian cancer, and cervical cancer. in 2010, bevacizumab injection was approved by china food and drug administration, administered in combination with 5-fluorouracil-based chemotherapy for the treatment of metastatic colon cancer, under the trade name avastin®. in 2014, the indication for non-small-cell lung cancer of the medicine also received approval from china food and drug administration.
reportedly, shanghai henlius has already completed the construction and transformation of its industrialization base for monoclonal antibody drugs. the base, taking the lead to adopt the advanced one-off manufacturing technology, can satisfy the clinical and market demand in the future.
as always, independent innovation remains the driving force for corporate development at fosun pharma. the company continues to optimize its innovative r&d system for medicine that integrates imitation and innovation, and has established highly efficient international r&d teams in shanghai, chongqing, san francisco and taipei. meanwhile, fosun pharma has committed to launching new products by constantly increasing investment in its research and development platforms. shanghai henlius, adhering to its core philosophy of “quality, speed and innovation”, will continue to build itself into a trustworthy leading biopharma company in china with significant global impact.