Fuhong Hanlin obtained the second clinical approval of monoclonal antibody drugs

On April 28, Fosun Pharmaceutical holding company Shanghai Fuhong Hanlin Biotechnology Co., Ltd (hereinafter referred to as "Fuhong Hanlin") formally received the second clinical approval document of Fuhong Hanlin antibody drug issued by the State Food and drug administration The drug is a recombinant human mouse chimeric anti-CD20 monoclonal antibody injection developed for rheumatoid arthritis As the R & D platform of biomacromolecule of Fosun Pharmaceutical, Fosun Hanlin has been adhering to the R & D concept of international standards, quality and efficiency priority for more than five years and implementing the R & D strategy of biomacromolecule This approval is the second clinical approval of McAb since the establishment of Fuhong Hanlin It is reported that Fuhong Hanlin has so far completed the clinical registration application for 7 indications of 5 monoclonal antibody varieties, and 7 innovative monoclonal antibodies are also in the follow-up R & D product line At present, all products under research of Fuhong Hanlin are the R & D achievements of the internal Transnational R & D team of the company These research and development achievements are mainly based on a number of world-class and complete monoclonal antibody research and development technology platforms established by Fuhong Hanlin, including phage expression library, antibody engineering, bispecific antibody technology platform, in vitro and in vivo pharmacodynamics evaluation system, quality analysis and structure confirmation method development, product production process development and GMP pilot production Fosun Pharmaceutical always takes independent innovation as the source power of enterprise development The company continues to pay attention to innovation and R & D, improve the drug R & D innovation system of "combination of imitation and innovation" By continuously increasing investment in the "4 + 1" R & D platform, Fosun Pharmaceutical fully supports R & D innovation and promotes the listing of new products As a national enterprise technology center, the company has established an efficient international R & D team in Shanghai, Chongqing and the United States.