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25 Aug 2015

BeiGene signs agreement with BioBAY for its first cGMP manufacturing facility for commercial use in Suzhou, China

BeiGene, a clinical-stage biopharmaceutical company focused on developing molecularly-targeted and immuno-oncology drugs for the treatment of cancer, is establishing its first cGMP biopharmaceutical manufacturing facility for commercial use at BioBAY in the Suzhou Industrial Park (SIP) in Suzhou, China.


Located less than one hour west of Shanghai, BioBAY, which is a subsidiary of SIP, has become one of the premier science innovation hubs in China to over 400 domestic and international biotech and biopharma companies for research, development, and manufacturing. BeiGene will also benefit from the local biotech
talent pool with the establishment of a new site in BioBAY.


The new 9000 m2 (96,875 sq ft) cGMP manufacturing facility expands the company’s production facilities and will supply materials for future clinical trials and subsequent commercial demand. The new manufacturing facility is expected to be completed by 2017.


“This new manufacturing facility is a key component to our strategic growth to become an integrated biopharma company and to accelerate and expand our development programs, which allows us to continue to focus on developing global best-in-class drugs for various cancer treatments and attract additional highly
talented professionals to our organization.” said John V. Oyler, CEO. “With a manufacturing site in BioBAY, we are well positioned to fully leverage the domestic regulatory pathway for our drugs in China and to build a global business”.


“This will be a truly cutting-edge, state-of-the-art facility utilizing the leading technologies in biomanufacturing that will also meet the utmost regulatory standards”, said Wendy Yan, Head of Regulatory Affairs. “Upon completion we will seek the necessary approvals to ensure our new site is fully compliant with regulatory procedures in all key global markets, including the US, Europe and China.” 

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