BeiGene signs agreement with BioBAY
Company announces 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 current Good Manufacturing Practice (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, a subsidiary of SIP, has become one of the premier science innovation hubs in China, home to more than 400 domestic and international biotechnology and biopharmaceutical companies for research, development and manufacturing.
The new 9000m2 cGMP manufacturing facility expands BeiGene’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 in our strategic plans to become an integrated biopharmaceutical company and to accelerate and expand our development programmes, enabling us to focus on developing global best-in-class drugs for various cancer treatments and attract additional highly talented professionals to our organisation,’ said John V. Oyler, Chief Executive Officer. ‘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 utilising 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 United States, Europe and China.’