henlius, biologics platform of fosun pharma receives official approval of the first new drug application (nda) for biosimilar
recently, shanghai henlius biotech company limited (hereinafter “shanghai henlius”), a biologics platform of fosun pharma, has duly received the notice of “approval for application of drugs”, pursuant to which the registration of rituximab biosimilar injection researched and developed by shanghai henlius (biosimilar, recombinant human/murine chimeric anti-cd20 monoclonal antibody injection, referred as the “new drug”), used for the treatment of non-hodgkin lymphoma, has been assessed and approved.
the new drug is a macromolecular biosimilar that independently researched and developed by fosun pharma, which is mainly used for treatments of non-hodgkin lymphoma and rheumatoid arthritis.
as of 30 october 2017, mabthera® of shanghai roche pharmaceuticals ltd.rituximab was the only biosimilar injection which is launched in china (excluding regions of hong kong, macau and taiwan). according to the statistics of ims chpa (provided by ims health, the global leading healthcare industry information and strategy consultation service provider), the sale volume of rituximab biosimilar injection in china for the year of 2016 was approximately rmb1.5 billion.
as of september 2017, r&d expenses of the new drug by fosun pharma was approximately rmb290 million.
meanwhile, recombinant anti-tnfα fully humanized monoclonal antibody injection (hereinafter the “new drug”) independently researched and developed by shanghai henlius used for the treatment of plaque psoriasis indication has launched the third phase of clinical testing recently. the new drug is a macromolecular biosimilar that independently researched and developed by fosun pharma. as of september 2017, r&d expenses of the new drug (including rheumatoid arthritis indication and plaque psoriasis indication) was approximately rmb97 million.
as biologics platform of fosun pharma, shanghai henliu is pioneer in antibody biosimilar and strives benefit more cancer patients through constructing a mature r&d platform of biosimilar to facilitate the progress of r&d and increase the accessibility of targeting therapeutic drug. with a great mission of “contributing to global patients by providing high-quality biosimilars with continuous innovation and outstanding operation”, shanghai henlius will continue to explore and develop with a focus on provision of high-quality biosimilar with reasonable prices, and strive to become a respectful innovative biosimilar pharmaceutical corporate in the world.
fosun pharma always regards innovation as the driving force for its business growth and continue to optimize the r&d system that integrates imitation and innovation. in recent years, the company has continued to increase r&d investment and formed an internationalized r&d layout with strong capability.