Junshi Biotech (01877): Phase III clinical trial of JS207 combined with JS007 for first-line treatment of advanced hepatocellular carcinoma completed the first patient administration

Zhitong Finance App News, Junshi Biotech (01877) issued an announcement. Recently, the company's product recombinant humanized anti-PD-1 and VEGF bispecific antibodies (code: JS207) combined with recombinant humanized anti-CTLA4 monoclonal antibodies (code: JS007) on the efficacy and safety of betarelizumab combined with bevacizumab in first-line treatment of advanced hepatocellular carcinoma (hereinafter referred to as the “JS207-017-III-HCC study”). NCT07823348) First patient administration has been completed. This study is the first domestically registered clinical study of JS207.

JS207 is a recombinant humanized anti-PD-1 and VEGF bispecific antibody independently developed by the company, which is mainly used for the treatment of advanced malignant tumors. JS207 can simultaneously bind PD-1 and VEGFA with high affinity, effectively block the binding of PD-1 to PD-L1 and PD-L2, and inhibit the binding of VEGF to its receptors. JS207 has the curative properties of immunotherapeutic agents and antiangiogenic drugs. By neutralizing VEGF, it can inhibit vascular endothelial cell proliferation, improve the tumor microenvironment, and increase the infiltration of cytotoxic T lymphocytes in the tumor microenvironment, thereby achieving better anti-tumor activity.

JS007 is a recombinant humanized anti-CTLA-4 monoclonal antibody injection independently developed by the company, which is mainly used for the treatment of advanced malignant tumors. Cytotoxic T lymphocyteassociated antigen-4 (CTLA-4) is an important receptor for T-cell surface regulation of immune responses. Studies have shown that JS007 can specifically bind to CTLA-4 and effectively block the interaction of CTLA-4 with its ligand B7 (CD80 or CD86), thereby activating T lymphocytes and inhibiting tumor growth.

The JS207-017-III-HCC study is a multicenter, randomized, controlled, open phase III clinical study to compare the efficacy and safety of JS207 in combination with JS007 and treprilizumab combined with bevacizumab for first-line advanced hepatocellular carcinoma. The study plans to enroll 560 participants. The primary endpoints were progression-free survival (PFS) and overall survival (OS).