Our main manufacturing site in Chengdu is equipped with cGMP-compliant, end-to-end capabilities covering the entire lifecycle of antibody and ADC drugs, encompassing the full-spectrum production process from cell culture and purification, for antibody manufacturing, through payload and linker synthesis and ADC conjugation, to Fill and Finish. Our manufacturing facilities for ADC drug product 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 liquid ADCs. Our manufacturing facilities for antibody drug product 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 liquid solutions.
We actively introduce high-quality external CMO resources to establish a flexible production system that integrates complementary in-house and external capabilities, thereby expanding our production capacity reserves and strengthening our ability to meet clinical and commercial supply needs. In preparation for the anticipated ramp-up in commercial production, work relating to post-approval changes to manufacturing sites is progressing in an orderly manner to align our manufacturing footprint with our commercialization plans in compliance with the applicable requirements.
