2025/ 06/10

CSPC Innovation's SYS6040 antibody-drug conjugate has been approved for clinical trials in the United States.

On June 10, CSPC Innovation Pharmaceutical Co., Ltd. (Stock Name: Sunnova, Stock Code: 300765.SZ) announced that its subsidiary, CSPC Group JW Therapeutics Co., Ltd. (hereinafter referred to as "JW Therapeutics"), has recently received notification from the U.S. Food and Drug Administration (hereinafter referred to as the "FDA") that the investigational new drug application for SYS6040 for injection submitted by JW Therapeutics has been approved by the U.S. FDA, allowing clinical trials to be conducted in the United States.

SYS6040 is a monoclonal antibody-drug conjugate that binds to specific receptors on the surface of tumor cells, enters cells via endocytosis and releases cytotoxic payloads to kill tumor cells. The approved clinical indication is advanced solid tumors. Preclinical studies have demonstrated that SYS6040 exhibits favorable anti-tumor activity against multiple types of cancer and holds high clinical development value. Multiple patent applications for this product have been filed both in China and internationally.