26. September 2016

BeiGene Receives Approval to Initiate Clinical Trials in China with PD-1 Antibody Supplied by the Boehringer Ingelheim Biopharmaceutical Site in China

BeiGene announced that it has received Clinical Trial Application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct clinical trials in China with its drug candidate BGB-A317, a humanized monoclonal antibody against immune checkpoint receptor PD-1, for the treatment of advanced solid tumors. China is the fifth territory in which BGB-A317 has received approval to conduct clinical trials, in addition to Australia, New Zealand, the United States, and Taiwan.

Boehringer Ingelheim’s Biopharmaceutical Contract Manufacturing Business, which is represented by the global brand Boehringer Ingelheim BioXcellence™, has been providing Chemistry, Manufacturing, and Control (CMC) development and manufacturing services for BGB-A317 since the project initiation. The manufacturing process and analytical methods were developed at Boehringer Ingelheim’s Biberach site in Germany, and transferred successfully to its operations site in Shanghai, China for manufacturing and global GMP supply. Boehringer Ingelheim also provides China CTA and global regulatory filing services for BGB-A317 from CMC perspective, which supported the successful application approvals.

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.

About BeiGene

BeiGene is a global, clinical-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 250 scientists, clinicians and staff in mainland China, the United States, Australia and Taiwan, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. For more information, please visit www.beigene.com.

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