Adherence to the Highest Standards of Manufacturing

Adherence to the Highest Standards of Manufacturing

Our manufacturing sites have been deemed to be in compliance with good manufacturing processes by the U.S. Food & Drug Administration (FDA), the State Market Regulatory Administration in China and European regulatory agencies. BeiGene’s commitment is to never compromise on the safety, compliance and quality of our products, our research, or our services. We are focused on serving patients by delivering quality drug products that consistently meet or exceed all customer and regulatory requirements.

Highest Standards of Manufacturing

Manufacturing Facilities

Suzhou Facility
Suzhou Manufacturing

Our manufacturing facility in Suzhou, China, produces our small molecule and biologic drug candidates for both clinical supply and for commercial supply, if approved. This facility consists of one oral solid dosage production line for small molecule drug products and one pilot plant for monoclonal antibody drug substances. In January 2018, the facility received a manufacturing license from the provincial FDA, which is required for the commercial manufacturing of zanubrutinib in China following its approval.

Guangzhou Facility
Guangzhou Manufacturing - Coming in 2019

We have a joint venture with the Guangzhou Development District and its affiliate, Guangzhou GET Technology Development Co., Ltd., to build a commercial-scale biologics manufacturing facility in Guangzhou, China. Construction began in 2017 and we expect the first phase of the facility to be completed and operational in 2019.

Boehringer Ingelheim
Manufacturing Collaboration with Boehringer Ingelheim

We entered into a supply agreement with Boehringer Ingelheim in 2013 for tislelizumab. Tislelizumab is manufactured in Boehringer Ingelheim’s world-class biopharmaceutical manufacturing facility in Shanghai as part of a Marketing Authorization Holder (MAH) trial project pioneered by BeiGene and Boehringer Ingelheim.

Catalent
Manufacturing Collaboration with Catalent

We entered into a supply agreement with Catalent in 2016 for zanubrutinib. In addition to BeiGene’s Suzhou manufacturing facility, zanubrutinib is manufactured at Catalent’s Kansas City location to support our expansive clinical program. We also work with Catalent in clinical packaging and distribution at their sites in Asia-Pacific, the U.S., and Europe, which enables us to optimize our clinical supply strategy for the planned product launches.

Our Molecules

We are advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients. We have three internally-developed late-stage clinical drug candidates and three marketed products in China.

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