AsianScientist (Apr. 2, 2015) – WuXi PharmaTech Inc., an open-access R&D capability and technology platform company, has received China Food and Drug Administration (CFDA) approval for a investigational new drug (IND) application for their anti-IL6 monoclonal antibody for rheumatoid arthritis.
In September 2012, MedImmune, the global biologics research and development arm of AstraZeneca, and WuXi AppTec formed the joint venture WuXi MedImmune Biopharmaceutical Co. Limited to develop and commercialize MEDI5117, an investigational, long-acting monoclonal antibody for autoimmune and inflammatory diseases. The joint venture was the first such collaboration between a global and a Chinese company to develop novel biologics.
WuXi AppTec completed the nonclinical and clinical sections of the dossier, while 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.
The IND application has now been entered into the system of the CFDA for technical review. WuXi AppTec will continue to provide manufacturing for the program at its state-of-the-art biologics facilities, the first in China to meet cGMP standards of the United States, the European Union and China, as well as provide local regulatory, pre-clinical and clinical trial support.
“We are very pleased that our collaboration with MedImmune has advanced this important novel class 1 biologic on schedule,” said Dr. Li Ge, Chairman and CEO of WuXi PharmaTech. “This initiative showcases WuXi’s capabilities as a gateway for developing novel biologics in China.” said Dr. Li Ge, Chairman and CEO of WuXi PharmaTech.
Source: WuXi AppTec; Photo: NIAID/Flickr/CC.
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