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2017/01/18

Novel Anti-IL-6 Antibody for Rheumatoid Arthritis from WuXi–MedImmune Joint Venture Receives Clinical Trial Permit (CTP) from CFDA

SHANGHAI and GAITHERSBURG, Md., Jan 18, 2016 -- WuXi AppTec, a global R&D enabling platform company, and MedImmune, the global biologics research and development arm of AstraZeneca, announced today that an Investigational New Drug (IND) application for WBP216 (MEDI5117), a novel anti-IL-6 antibody for rheumatoid arthritis (RA) and other autoimmune disorders—developed by their joint venture, WuXi MedImmune—has been approved by the China Food and Drug Administration (CFDA) as a class I biologic to enter Phase 1 clinical trials in China.

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2016/10/21

WuXi AppTec Receives Inaugural “Company of the Year” Award from BayHelix

SHANGHAI, Oct. 21, 2016 --WuXi AppTec, a leading pharmaceutical, biotechnology, and medical device technology platform company, today announced that it has received the inaugural “Company of the Year” Award from BayHelix at a ceremony during the 3rd BioCentury China Healthcare Summit in Shanghai, China. The award is part of BayHelix China Healthcare Awards series, celebrating outstanding individuals and companies for their achievement and contribution to the China healthcare ecosystem.

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2016/10/06

WuXi AppTec Unveils Manufacturing Center for Cutting Edge Cell and Gene Therapies

SHANGHAI and Philadelphia, October 6, 2016 – WuXi AppTec (WuXi), a leading pharmaceutical, biotechnology, and medical device technology platform company, celebrated the grand opening of their new 150,000 square foot biomanufacturing facility in an event attended by Pennsylvania Lieutenant Governor Mike Stack and WuXi AppTec Chairman and Chief Executive Officer, Dr. Ge Li. The new facility is WuXi AppTec’s third facility in the Philadelphia Navy Yard. When fully configured, the facility could employ an additional 200 manufacturing and support staff.

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2016/08/15

WuXi AppTec’s STA Subsidiary Passed Third U.S. FDA Inspection

SHANGHAI, August 15, 2016 -- WuXi AppTec Co. Ltd. (WuXi), a leading open-access R&D capability and technology platform company serving the pharmaceutical, biotechnology, and medical device industries, today announced that the small molecule active pharmaceutical ingredient (API) and advanced intermediate manufacturing facility located in Jinshan Shanghai, which is part of its subsidiary Shanghai SynTheAll Pharmaceutical Co., Ltd. (STA), recently successfully passed a general GMP and Pre-Approval Inspection from the U.S. Food and Drug Administration with no Form 483s issued. This is the third time that STA’s Jinshan facility passed the U.S. FDA inspection.

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2016/08/08

WuXi AppTec’s STA Subsidiary Opens Operations in San Diego

SHANGHAI and San Diego, August 8, 2016 – WuXi AppTec (WuXi), a leading open-access R&D capability and technology platform company serving the global pharmaceutical, biotechnology and medical device industries, today announced that its small-molecule process development and manufacturing subsidiary, Shanghai SynTheAll Pharmaceutical Co., Ltd. (STA), is opening operations in San Diego, which provides Process R&D and API manufacturing services for early phase clinical studies.

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