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BeiGene inks pact with BioBAY to set up its first cGMP manufacturing unit at Industrial Park in China
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Beijing, China
Saturday, August 22, 2015, 13:00 Hrs  [IST]

BeiGene, Ltd., a clinical-stage biopharmaceutical company focused on developing molecularly-targeted and immuno-oncology drugs for the treatment of cancer, announced that it is establishing its first current good manufacturing practices (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 9,000 square meter (96,875 square feet) 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 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.”



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