Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co. Ltd. announced Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co. Ltd. FDA022 antibody drug conjugate for injection (Her2-BB05 directed ADC, the "Drug") for the treatment of advanced solid tumors of the Company is undergoing phase I clinical study (the "Study"), and the first patient has recently been successfully enrolled in the Study. In recent years, the Company has built a new Linker-Drug platform ("BB05 Platform") with independent intellectual property rights in respect of small molecule. The Drug is the first new generation antitumor antibody-drug conjugate (ADC) drug on the BB05 Platform. It is composed of monoclonal antibodies against human epidermal growth factor receptor 2 (HER2) target coupled with BB05. The Drug can bind to HER2-expressed tumor cells and endocytosis, releasing small molecule
cytotoxic drugs (topoisomerase I inhibitors) in lysosomes by protease cleavage to kill the tumor cells. The Drug is intended to be developed for the treatment of advanced solid tumors with HER2-positive expression, such as breast cancer, gastric cancer, lung cancer, colorectal cancer, etc. According to the public data, the HER2 target ADC products currently on the market are Kadcyla« (T-DM1), Enhertu« (T-DXd) and Disitamab Vedotin For Injection (RC48-vc-MMAE).