The board of directors of Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.,Ltd. announced that, the Company has received the Acceptance Notice issued by the National Medical Products Administration of the PRC (the "NMPA"). The investigational new drug (the "IND") application for Phase I clinical trial of FDA022 antibody drug conjugate for injection (Her2-BB05 directed ADC, the "Drug") for the treatment of advanced solid tumors has been accepted. Relevant information is as follows: Drug name: FDA022 antibody drug conjugate for injection.

Registration type: Class 1 therapeutic biological products. Application matter: Registration of Clinical Trial of Domestic Production of Pharmaceutical Product. Acceptance No.

CXSL2200252GUO. Applicant: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co. Ltd. Review conclusion: Accepted upon review according to the requirements of Article 32 of the Administrative License Law of the People's Republic of China.

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).