CSPC PHARMA (01093): SYS 6043 (Antibody-Drug Conjugate) has received approval for clinical trials in the United States.

CSPC PHARMA (01093) announced that the investigational new drug (IND) application for SYS 6043 (antibody-drug conjugate) developed by the group has been approved by the Food and Drug Administration (FDA) in the United States, allowing for clinical trials to be conducted in the US. Prior to this, the product was granted approval by the National Medical Products Administration of the People's Republic of China in December 2024, allowing for clinical trials to be conducted in China. This product is a monoclonal antibody-drug conjugate that can bind to specific receptors on the surface of tumors, enter cells through internalization, and release toxins to kill tumor cells. The approved indication for this clinical trial is advanced/metastatic solid tumors, and the product is expected to be used in the treatment of small cell lung cancer, esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, prostate cancer, liver cell carcinoma, etc. Preclinical studies have shown that this product has a good anti-tumor effect on a variety of cancers and has high clinical development value. Multiple patent applications for this product have been submitted domestically and internationally.