CFDA accepts WuXi-MedImmune’s IND for new mAb

By Zachary Brennan contact

- Last updated on GMT

CFDA accepts WuXi-MedImmune’s IND for new mAb

Related tags: Investigational new drug, Wuxi

The China Food and Drug Administration (CFDA) has accepted for review an Investigational New Drug (IND) application for WuXi and MedImmune's novel anti-IL6 monoclonal antibody (mAb) for rheumatoid arthritis. 

In September 2012, MedImmune, the biologics R&D arm of AstraZeneca, and WuXi formed the joint venture to develop and commercialize MEDI5117, a novel, investigational, long-acting mAb for autoimmune and inflammatory diseases. 

WuXi completed all CMC (chemistry, manufacturing and control), 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.  WuXi's biologics and pre-clinical facilities in Shanghai, Suzhou, and Wuxi, China, passed the Jiangsu FDA's onsite inspections in January. 

The IND application has now been entered into the system of the CFDA for technical review. WuXi will continue to provide manufacturing for the program at its biologics facilities, as well as provide local regulatory, pre-clinical, and clinical trial support. 

Related topics: Clinical Development, Phase III-IV

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