2025/ 04/14

CSPC Innovation's Antibody-Drug Conjugate SYS6041 Approved for Clinical Trials in the United States

On April 14, 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 (IND) application for SYS6041 for injection submitted by JW Therapeutics has been approved by the U.S. FDA, allowing clinical trials to be conducted in the United States.微信图片_20250415150729.png


SYS6041 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 indication approved for clinical development is advanced solid tumors. Preclinical studies have demonstrated that SYS6041 exhibits favorable anti-tumor activity against multiple types of cancer and possesses high clinical development value. Multiple patent applications for this product have been filed both domestically and internationally. Previously, in January 2025, this product had already been approved by the National Medical Products Administration (NMPA) of the People's Republic of China to initiate clinical trials in China.