Our main manufacturing site in Chengdu is one of the few facilities in China with cGMP-compliant, end-to-end capabilities covering the entire development lifecycle of ADCs, from cell culture and purification, for antibody production, syntheses of payloads and linkers, ADC conjugation to formulation, fill and finish. Our ADC manufacturing facilities have an annual production capacity of 50 batches (or 1.4 million vials) of freeze-dried ADCs or 100 batches (or 2 million vials) of injectable ADCs. Our antibody manufacturing facilities have an annual production capacity of 60 batches (or 750,000 vials) of freeze-dried formulation or 100 batches (or 2.6 million vials) of injectable solutions.
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 quality management innovation, prioritize patients’ benefits, and improve supply chain security and drug accessibility. On June 26, 2025, our innovative ADC biological product, trastuzumab botidotin, received official approval from the NMPA to carry out the cross-provincial segmented production pilot program.
