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.
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.
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.
A limited number of highly validated external contract manufacturers supply some drug substances and drug products to meet the preclinical, clinical, and potential commercial requirements for our investigational and marketed medicines.
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.