Wuxi-MedImmune JV sees CFDA accept RA mAb for review

An Investigational New Drug application for WuXi PharmaTech ($WX) and MedImmune's novel anti-IL6 monoclonal antibody (mAb) for rheumatoid arthritis was accepted for review by the China Food and Drug Administration, the company said this week, marking a milestone in a development partnership started less than three years ago.

NYSE-listed WuXi, an open-access R&D capability and technology platform company serving the global pharmaceutical, biotechnology and medical device industries, said the candidate, MEDI5117, accepted was a novel anti-IL6 monoclonal antibody for rheumatoid arthritis.

The candidate came out of a joint venture formed in September 2012 with MedImmune, the global biologics research and development arm of AstraZeneca ($AZN), and WuXi AppTec.

The venture, WuXi MedImmune Biopharmaceutical, saw WuXi complete all chemistry, manufacturing and control for the nonclinical and clinical sections of the dossier with the IND filed with the Jiangsu provincial FDA as a Class 1 therapeutic in December 2014.

- here's the release

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