Manufacturing
Global Integrated Capabilities
We are a commercial stage biopharmaceutical company with a global footprint. We have fully integrated capabilities from discovery, clinical development to manufacturing and commercialization. We adopt a global clinical development strategy and leverage our CMC (chemistry, manufacturing, and controls) to comply with the requirements applicable to clinical trials globally in accordance with the requirements of the FDA, the NMPA, the EMA, and other comparable regulatory authorities.
Our Global R&D Center and GMP Facility
Our global manufacturing facility is located in Suzhou, Jiangsu Province, China and has been operational since the fourth quarter of 2022. The center has more than 200,000 square feet of space, with a manufacturing capacity for both oral solid tablets and capsules of up to 250 million dosage units per year. We also maintain manufacturing capabilities for lyophilized formulations at our Suzhou center. In 2022, we were issued a Drug Manufacturing License (Certificate A), which will allow us to produce innovative drugs with global patents and global market potential in Suzhou, and we also hold a PRC drug export permit, which allows us to supply drugs to the global market. Our global manufacturing center enables further transformation from a biotech company to a biopharma company.
In April 2023, we received a zero-deficiency report from the GMP compliance audit of our global manufacturing center by a Qualified Person (QP) of the EU. We believe this successful audit indicates that our Suzhou manufacturing center and the quality management system implemented at the site are compliant with international standards such as EU GMP in preparation for our continued global expansion.
