13. January 2016

BeiGene’s U.S. IND becomes active for BGB-A317, a humanized PD-1 Inhibitor monoclonal antibody

BeiGene announced on January 8th, 2016 that the United States Food and Drug Administration (FDA) has completed its review of the IND for clinical development of its drug candidate BGB-A317, a humanized monoclonal antibody against immune checkpoint receptor PD-1. This will allow BeiGene to include U.S. clinical sites in its ongoing study of BGB-A317 in patients with relapsed or refractory solid tumors.


Boehringer Ingelheim BioXcellence™ is providing development and manufacturing services for the lead candidate BGB-A317 since the project initiation. The manufacturing process and analytical methods were developed at Boehringer Ingelheim’s Biberach site, Germany, and transferred successfully to its newly established site in Shanghai, China for manufacturing and global GMP supply.


In 2014, Boehringer Ingelheim and BeiGene entered into a strategic agreement whereby Boehringer Ingelheim BioXcellence provides high quality CMC services in China for BeiGene’s lead biopharmaceutical molecules.

 

About Boehringer Ingelheim Biopharmaceuticals China

As one of the world’s leading organizations in biopharmaceutical contract manufacturing, Boehringer Ingelheim is the first multi-national pharmaceutical company to establish biopharmaceutical contract manufacturing operations in China. With over 30 years of experience in biopharmaceuticals, Boehringer Ingelheim looks forward to serving patients and the biopharmaceutical industry via the newly established manufacturing capabilities in Shanghai.

Boehringer Ingelheim Biopharmaceuticals China currently operates at 100L and 500L manufacturing scales for GMP clinical material supply at BioLab, Shanghai. Boehringer Ingelheim is also constructing a new facility Oasis in Shanghai with startup of GMP operations targeted for begin of 2017. The Oasis site will include 2000L single-use bioreactor and fill/finish capabilities. Further expansion at Shanghai will depend upon business growth. For more information, please visit http://www.bioxcellence.com.

 

About BeiGene

BeiGene is an innovative, global, clinical-stage biotechnology company focused on discovering, developing and commercializing targeted and immuno-oncology therapeutics. With a team of over 215 scientists and staff, BeiGene is advancing a pipeline of novel small molecules and monoclonal antibodies for cancer. BeiGene is working to create solutions having a significant, lasting impact on cancer patients.  For more information, please visit www.beigene.com.

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