WuXi MedImmune Biopharmaceutical is a joint venture (JV) formed in September 2012 by AstraZeneca’s global biologics research and development arm MedImmune, and WuXi AppTec.
The JV was created to develop and commercialize MEDI5117, a new, investigational, long-acting monoclonal antibody for autoimmune and inflammatory diseases.
All CMC, nonclinical and clinical sections of the dossier have been completed by WuXi AppTec, which filed an IND for it with the Jiangsu provincial FDA as a Class 1 therapeutic biologic in December 2014.
In January 2015, WuXi AppTec’s biologics and pre-clinical facilities in Shanghai, Suzhou, and Wuxi passed the Jiangsu FDA’s onsite inspections.
Currently, the IND has entered into the system of the CFDA for technical review and WuXi AppTec will continue to provide manufacturing for the program at its biologics facilities as well as offer local regulatory, pre-clinical and clinical trial support.
The company’s facilities are the first in China to meet cGMP standards of the US, the EU and China.
WuXi PharmaTech chairman and CEO Dr Ge Li said: "We are very pleased that our collaboration with MedImmune has advanced this important novel class 1 biologic on schedule.
"WuXi’s capabilities in integrated biologics discovery, development, and manufacturing offer a global platform with the highest quality standards. This initiative showcases WuXi’s capabilities as a gateway for developing novel biologics in China."