AstraZeneca announces JV in China for biotech drug

News

Hannah Blake

pharmaphorum

AstraZeneca’s MedImmune unit has announced a joint venture (JV) with WuXi AppTec, to develop and market the experimental biological drug MEDI5117 in China. MEDI5117 is a fully human monoclonal antibody, for treatment of autoimmune and inflammatory diseases, such as rheumatoid arthritis.

A local investigational new drug application will be filed for MEDI5117 in China, after which, Phase 1 trials will begin. China’s government requires local manufacture of medicines that have not been approved in other markets - MEDI5117 is currently in early-stage development in the US and Europe.

Under terms of the agreement, the two companies will have equal ownership, with AstraZeneca (AZ) having an option to acquire full rights to commercialise MEDI5117. WuXi will provide local regulatory, manufacturing, pre-clinical and clinical trial support to AZ’s MedImmune.

“We are pleased to partner with WuXi AppTec, a company with strong leadership in the Chinese pharmaceutical R&amp,D sector, to help us address the healthcare needs of Chinese patients through the co-development of MEDI5117. This strategic partnership will enable us to establish a leadership presence in developing novel biologics in China, complementing AstraZeneca’s investment in this important emerging market.”

Bahija Jallal, Executive Vice President, Research &amp, Development, MedImmune.

The move to partner with a local company could see the drug launched around four to six years earlier in China, compared to the conventional route of getting an import license after approval in the US or Europe.

AZ sees China as a critical part of its future growth, since establishing its operation in China in 1993. In the last quarter, AZ’s sales in China rose by 12%.

 EU-Clinical-Trial-Directive-Regulatory-Requirements-20Sep12

Related news:

AstraZeneca fast-tracks biotech drug with China JV (Reuters)

AstraZeneca forms Chinese joint venture for biologic drug (First Word Pharma)

MedImmune And WuXi AppTec Announce Joint Venture To Develop Novel Biologic For Chinese Market (Daily Markets)

profile mask

HannahBlake

14 September, 2012