We are pleased to share with you that an Investigational New Drug (IND) application for WuXi MedImmune’s novel anti-IL6 monoclonal antibody for rheumatoid arthritis has been accepted for review by the China Food and Drug Administration (CFDA).
WuXi MedImmune Biopharmaceutical Co. Limited is a joint venture that we formed in September 2012 with MedImmune, the global biologics research and development arm of AstraZeneca, to develop and commercialize MEDI5117, a novel, investigational, long-acting monoclonal antibody for autoimmune and inflammatory diseases. It was the first collaboration in China between a global company and a Chinese company to develop novel biologics. We completed all CMC, nonclinical, and clinical sections of the dossier, and the wholly owned subsidiary of the joint venture filed an IND for it with the Jiangsu provincial FDA as a Class 1 therapeutic biologic in December 2014. We will continue to provide manufacturing for the program at our biologics facilities, as well as provide local regulatory, pre-clinical, and clinical trial support. This initiative showcases WuXi’s capabilities as a gateway for developing novel biologics in China.