Adherence to the Highest Standards of Manufacturing
Our manufacturing sites have been designed to operate in compliance with Good Manufacturing Practice (GMP) standards adopted by the U.S. Food & Drug Administration (FDA), the China National Medical Products Administration (NMPA) and European Medicines Agency (EMA).
Our manufacturing facility in Suzhou, China, produces our small molecule drug candidates for both clinical supply and commercial supply. 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 health authorities, which is required for the commercial manufacturing of zanubrutinib in China following its approval.
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. The Guangzhou manufacturing facility received approval from the China National Medical Products Administration in 2021 to begin manufacturing commercial supply of BeiGene’s approved anti-PD-1 antibody. Construction began in 2017 and the initial phase of construction and facility validation was completed in 2019. An additional phase of construction currently in progress to bring total capacity to 64,000 liters is expected to be completed by the end of 2022.
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.
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 and the commercial supply in the U.S. 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.
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 one marketed product in the U.S. and five marketed products in China, including two internally-developed ones.