Chinese CRO WuXi AppTec has opened a biologics manufacturing plant in Shanghai that will initially serve a joint venture it has with AstraZeneca ($AZN) to develop an IL-6 inhibitor to treat rheumatoid arthritis and autoimmune disorders that is being developed for the Chinese market.
While providing few details of the new facility, the company claims that it is the first biologics plant in China to meet GMP standards for the U.S. and EU as well as China, and is the first biologics plant in the world to use all disposable technology.
AstraZeneca's biologics arm, MedImmune, and WuXi AppTec in September announced their joint venture, a partnership that analysts said would allow AstraZeneca to more quickly move MEDI5117 to market if it is approved. The British company pointed out at the time that China requires a local manufacturer for trials of any drug that has not been approved elsewhere. Martin Mackay, president of R&D at AstraZeneca, attended the official opening of the plant last week.
In addition to its venture with MedImmune, WuXi AppTec recently landed two other high-profile biologics deals, FierceCRO points out. Last month, WuXi partnered with Open Monoclonal Technology to develop human antibodies using that company's OmniRat platform. WuXi also signed on with TaiMed Biologics to produce its ibalizumab HIV treatment.
Lots of large companies are looking to expand in China because of its growth potential but they also are looking for the right localization plan for manufacturing in China, whether to build plants, outsource to Western companies that have operations there or to partner with Chinese companies.
- here's the release
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