On January 18, 2023 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.* (the "Company") reported that has received the Acceptance Notice (《受理通知書》) issued by the National Medical Products Administration of the PRC (the "NMPA") (Filing, Shanghai Fudan-Zhangjiang, JAN 18, 2023, View Source [SID1234633120]). The board of directors (the "Board") of the Company is pleased to announce that, the Company has received the Acceptance Notice (《受理通知書》) 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 FZ-AD004 antibody drug conjugate for injection (Trop2-BB05 ADC, the "Drug") for the treatment of advanced solid tumors has been accepted. Relevant information is as follows: ABOUT THE DRUG Drug name: FZ-AD004 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. CXSL2300047 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.-2-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 second new generation antitumor antibody-drug conjugate (ADC) drug on the BB05 Platform. It is composed of monoclonal antibodies against human trophoblast cell surface glycoprotein antigen ("TROP-2") target coupled with BB05. TROP-2 is expressed at different levels, and its expression level is significantly increased in various carcinomas, such as breast cancer, lung cancer, and stomach cancer. The Drug can bind to high TROP-2-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 including but not limited to lung cancer, breast cancer, gastric cancer, esophageal cancer, colorectal cancer, urothelial cancer, bladder cancer and endometrial cancer, etc. Due to the high-tech, high-risk and high-value-added characteristics of pharmaceutical products, and the long cycle and numerous stages in the process, there are uncertainties in drug pre-clinical research, clinical trial and commercialization. These many stages make it susceptible to uncertainties and therefore, investors are advised to make cautious decisions and pay careful attention to investment risks. The Company will actively facilitate the above research and development project and fulfill its information disclosure obligations in a timely manner for subsequent progress in strict accordance with relevant regulations.
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