CSPC Innovation's SYS6040 ADC gets US FDA go-ahead

CSPC Innovation Pharmaceutical Group (SZSE:300765) announced that its holding subsidiary, CSPC Jishi Pharmaceutical, has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for SYS6040, an antibody-drug conjugate (ADC). The approval allows CSPC Jishi to proceed with clinical trials of SYS6040 in the U.S. for advanced solid tumors. SYS6040 is designed to bind to specific receptors on tumor cells, enter the cells via endocytosis, and release a toxin to kill the cancer cells. Preclinical studies have demonstrated promising anti-tumor activity against various cancers. SYS6040 has also been approved for clinical trials in China, which was announced in March 2025. While this FDA approval is a significant step, the company cautions that drug development involves considerable investment, risks, and lengthy timelines and that the impact on short-term performance will not be significant.