WuXi and AstraZeneca roll toward Chinese approval with an arthritis drug

Partners WuXi PharmaTech ($WX) and AstraZeneca's ($AZN) MedImmune are on schedule with a rheumatoid arthritis-treating antibody designed for the Chinese market, as the country's regulators have accepted their application.

The injection, MEDI5117, is an interleukin-7 antibody designed to tamp down the inflammation at the heart of autoimmune diseases like arthritis. The pair are developing the drug through a joint venture launched in 2012, maintaining equal ownership until the drug reaches the market, at which point AZ would have the option to buy out its partner. The JV submitted MEDI5117 to the Chinese FDA in December, and, with the application's acceptance, WuXi and MedImmune expect to get a final decision this year.

AstraZeneca cut the cord on an osteoarthritic pain program for MEDI5117 last year but preserved the antibody's Chinese ambitions, relying on WuXi to handle development and manufacturing.

MEDI5117 presents a significant bit of potential revenue for the fast-growing CRO, which has augmented its traditional offerings with a few risk-sharing drug development deals. WuXi's long-stated goal is to become the go-to partner for any drugmaker looking to break into the Chinese market, and its relationship with AstraZeneca could light the way for more collaborations, CEO Ge Li said.

"This initiative showcases WuXi's capabilities as a gateway for developing novel biologics in China," Li said in a statement.

Meanwhile, the CRO is forecasting 2015 revenue between $790 million and $800 million, good for 18% annual growth at midpoint. To get there, WuXi is planning to spend up to $200 million on capital projects, nearly double last year's budget, building new manufacturing outposts in China and expanding the company's genomics heft with new lab capacity.

- read the statement

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