WuXi AppTec (WuXi) has announced that it has formed a strategic alliance with MedImmune, the global biologics research and development arm of AstraZeneca. This strategic alliance will bring cutting-edge research and technical capability for biologics to China with the aim of addressing unmet patient needs in AstraZeneca's main therapy areas of respiratory, inflammation and autoimmunity; cardiovascular and metabolic diseases; and oncology.
Under the agreement, AstraZeneca has the option to acquire WuXi AppTec's biologics manufacturing facility in Wuxi city, one of several manufacturing facilities for WuXi, in the next few years. Prior to that, WuXi Biologics, the biologics division of WuXi AppTec, remains the exclusive partner for R&D manufacturing for MedImmune's innovative biologics in China.
The alliance builds on the existing joint venture between WuXi and MedImmune that was formed in 2012 to develop and commercialize MEDI5117, a novel biologic for autoimmune and inflammatory diseases. It is the first such collaboration in China between a global company and a Chinese company to develop novel biologics.
The IND application was subsequently accepted by CFDA for review in March 2015. WuXi will continue manufacturing for the program at its biologics facilities, the first in China to meet cGMP standards of the United States, the European Union and China. WuXi is committed to its manufacturing capabilities in China and will continue to provide its clients with the highest quality of service.
In April 2015, WuXi announced that it is building the largest biomanufacturing facility globally, using fourteen 2000L and two 1000L disposable bioreactors, which will support late-phase clinical and commercial manufacturing. The first phase of the facility will be operational in January 2017.
"We are very pleased that our collaboration with MedImmune has leapfrogged to another level of critical importance since our initial collaboration in 2012," said Dr. Ge Li, Chairman and CEO of WuXi AppTec. "The strategic alliance, the first of its kind in China, manifests the global standards and quality of biologics development and manufacturing at WuXi. Through this strategic partnership, WuXi truly offers a gateway for innovative biologics to be developed in China and to be made available to Chinese patients in an expedited fashion."
"We are delighted to continue and broaden our collaboration with WuXi AppTec, a company with strong leadership in the Chinese biopharmaceutical sector, to address the healthcare needs of local patients," said Dr. Bahija Jallal, Executive Vice President, MedImmune. "This strategic alliance, alongside our accelerated investments, will create a sustainable and strategic innovation platform in China and strengthen our leadership in developing next-generation biologics for both local needs and patients around the world."