We continuously promote the improvement of a comprehensive quality management system throughout the entire product lifecycle to ensure compliance with cGMP standards and regulatory developments in China, the United States, and Europe. The Company prioritizes quality, strengthens the segmented contract manufacturing management system for biological products, and achieves collaborative operations across multiple production sites and enterprises by dividing the production process into multiple stages. Through “standardized division of labor and refined management”, we enhance quality control, drive regulatory innovation, prioritize patients’ benefits, and improve supply chain security and drug accessibility. On October 14, 2025, our innovative ADC biological product, trastuzumab botidotin for injection (舒泰莱®), received official approval from the NMPA, marking it as the first ADC drug in China approved under a cross-province segmented production model.
