By Fineline Cube 
Subsidiary of China based Sino Biopharmaceutical Ltd (HKG: 1177) Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd’s (CTTQ) Category 1 biologic product TQB2102, an HER2-targeted antibody drug conjugate (ADC), has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The designation is for the neoadjuvant treatment of HER2-positive early or locally advanced breast cancer.
Mechanism of Action
TQB2102 is an HER2-targeted ADC designed to deliver precise treatment to HER2-positive tumor cells. Upon intravenous injection, the antibody component of TQB2102 binds to the ECD2 and ECD4 regions on the surface of HER2-positive tumor cells. The ADC complex is internalized and transported to the lysosome within the cell, where the linker releases cytotoxic small-molecule drugs after enzymatic digestion. This process leads to DNA damage and subsequent cell death.
Clinical Development
TQB2102 is currently the subject of 12 clinical studies, covering indications such as breast cancer, colorectal cancer, lung cancer, bile duct cancer, gastric cancer, and gastroesophageal junction cancer. Notably, the drug has advanced to Phase III clinical trials for first-line treatment of HER2-positive breast cancer.-Fineline Info & Tech