CSPC Innovation Pharmaceutical (300765.SZ) subsidiary SYS6043 antibody-drug conjugate receives approval from the US FDA.

CSPC Innovation Pharmaceutical (300765.SZ) announced that its holding subsidiary CSPC PHARMA Giant Stone Biopharmaceutical Co., Ltd. ("Giant Stone Biopharmaceutical") recently received notification from the U.S. Food and Drug Administration (FDA) that the clinical trial application for the injectable drug SYS6043 filed by Giant Stone Biopharmaceutical has been approved by the FDA and can be conducted in the United States. SYS6043 is a monoclonal antibody-drug conjugate that can bind to specific receptors on tumor surfaces, enter cells through internalization, and release toxins to kill tumor cells. The approved indication for this application is late-stage/metastatic solid tumors, and it 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 SYS6043 has a good anti-tumor effect on multiple types of cancer and has high clinical development value. The product has already submitted multiple patent applications domestically and internationally. According to the requirements of U.S. drug registration laws and regulations, after receiving the clinical trial approval notification, a series of clinical trials need to be conducted and approved by the FDA before the drug can be marketed and sold.