07/09/2026
Quality is at the core of everything we do. Innovent Biologics' Suzhou manufacturing base has successfully passed an on-site GMP inspection by the European Medicines Agency, receiving its EU GMP certificate with zero critical findings. The inspection covered the full scope of quality operations, from cell banking and drug substance/product manufacturing to QC labs, data integrity, and supply chain controls, and inspectors specifically noted the strength and maturity of Innovent's quality management system.
With this milestone, Innovent's manufacturing network now meets NMPA, FDA, and EMA standards simultaneously, supporting over 140,000 liters of active production capacity, roughly 20% of China's total biologics capacity.
This certification strengthens the regulatory foundation for Innovent's innovative biologics to enter the EU and other overseas markets, reflecting our continued commitment to bringing high-quality, affordable biologics to patients worldwide.