The antibody-drug conjugate SYS6051 developed by CSPC PHARMA (01093) has been approved for clinical trials in the United States.

CSPC PHARMA (01093) announced that the investigational new drug (IND) application for the antibody-drug conjugate SYS6051 developed by the group has been approved by the Food and Drug Administration (FDA) of the United States, allowing clinical trials to be conducted in the US. The product has also been approved by the National Medical Products Administration of the People's Republic of China in April 2026, enabling clinical trials to be conducted in China. This product is an antibody-drug conjugate targeting tissue factor (TF), which can bind to tissue factor on the surface of tumor cells, enter the cells through internalization, and release toxins to kill tumor cells. The approved indication for this product is advanced solid tumors. Preclinical studies have shown that the product has good antitumor effects on various types of cancers, and is expected to demonstrate good therapeutic effects in subsequent clinical trials.