Our Promise to
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. Each BeiGene employee and partner is responsible for achieving our quality objectives and for looking at any opportunity where we can improve upon our high standards of quality performance.
The Highest Standards in Clinical Research
Good Clinical Practice (GCP) is the universal ethical and scientific quality standard for conducting clinical trials. The GCP standard applies to all aspects of our clinical trial processes. Under these guidelines, quality is a continuum, which begins with designing, is critical during conducting and recording, and continues during the reporting of trials. It is a part of everything we do from research to reporting and dissemination of the knowledge we’ve gained.
Adherence to the Highest Standards of Manufacturing
Our manufacturing sites have received approvals from the U.S. Food & Drug Administration (FDA), the China National Medical Products Administration (NMPA), and European regulatory agencies.
Our Beijing R&D facility produces preclinical and clinical trial materials for some of our small molecule drug candidates
Our new Shanghai R&D center focuses on the research of macromolecule drug candidates for various malignant tumors and is capable of carrying out more than 20 preclinical projects simultaneously
Our 11,000-square meter multi-functional facility manufactures small molecule drugs at commercial scale and biologics drugs at pilot scale
Our 100,000-square meter, 50,000-liter commercial-scale biologics manufacturing facility has completed the initial phase of construction and facility validation in 2019
Our manufacturing sites have been deemed to be in compliance with good manufacturing processes by the U.S. Food & Drug Administration (FDA), the China National Medical Products Administration (NMPA) and the European Medicines Agency (EMA).