Shanghai Junshi Biosciences Co., Ltd. announced that, the Company has received the Clinical Trial Approval issued by the National Medical Products Administration. The investigational new drug application for the JS012 injection has been approved. Relevant information is as follows: Drug name: JS012 injection; Application matter: Clinical Trial of Domestic Production Registration of Pharmaceutical Product; Acceptance No.: CXSL2101324; Applicant: Shanghai Junshi Biosciences Co., Ltd.; Review conclusion: According to the Drug Administration Law of the People ' s Republic of China and relevant regulations, upon review, the JS012 injection accepted on 10 September 2021 meets the relevant requirements for drug registration and is approved to conduct clinical trials in accordance with the submitted protocol for advanced malignant solid tumors. The active ingredient of JS012 injection is recombinant humanised anti-Claudin18.2 monoclonal antibody, which can target Claudin18.2, inhibit related signal pathway, kill tumor cells by initiating antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), and is intended to be used for the treatment of advanced malignant tumors, such as gastric cancer and pancreatic cancer. Claudin protein is one kind of important molecule of tight junctions, and 27 members of this protein family have been found. Claudin18 is a member of Claudin protein family, which is encoded by Claudin18 gene in human body. Claudin18 has two protein subtypes, Claudin18.1 and Claudin18.2, both of which have tissue specificity. Claudin18.2 is mainly expressed in differentiated gastric epithelial cells in normal tissues, but not in gastric stem cells. However, abnormal initiation and overexpression of Claudin18.2 have been found in various primary malignant tumors such as gastric cancer, pancreatic cancer, esophageal adenocarcinoma, colon cancer and liver cancer, etc. Claudin18.2 has become a potential target because of its high specificity in normal tissues and initiation expression in various cancers. As of the date of this announcement, no similar target product has been approved for marketing globally.