Junshi Biosciences (01877) has issued an announcement that the first patient has been dosed in a multicenter, randomized, controlled, open-label Phase III clinical study (referred to as the "JS207-017-III-HCC study", NCT07823348) evaluating the efficacy and safety of the company's product, a recombinant humanized anti-PD-1 and VEGF bispecific antibody (code: JS207), in combination with a recombinant humanized anti-CTLA-4 monoclonal antibody (code: JS007), compared with toripalimab combined with bevacizumab for the first-line treatment of advanced hepatocellular carcinoma.

This study represents the first domestic registrational clinical trial for JS207.

JS207 is a recombinant humanized anti-PD-1 and VEGF bispecific antibody independently developed by the company, primarily intended for the treatment of advanced malignant tumors. JS207 can simultaneously bind to PD-1 and VEGFA with high affinity, effectively blocking the binding of PD-1 to PD-L1 and PD-L2, and inhibiting the binding of VEGF to its receptor. JS207 possesses the therapeutic characteristics of both immunotherapeutic agents and anti-angiogenic agents. By neutralizing VEGF, it can inhibit vascular endothelial cell proliferation, improve the tumor microenvironment, and increase the infiltration of cytotoxic T lymphocytes into 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, primarily intended for the treatment of advanced malignant tumors. Cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) is an important receptor on the surface of T cells that regulates immune responses. Studies have shown that JS007 can specifically bind to CTLA-4 and effectively block the interaction between CTLA-4 and its ligands B7 (CD80 or CD86), thereby activating T lymphocytes and inhibiting tumor growth.

The JS207-017-III-HCC study is a multicenter, randomized, controlled, open-label Phase III clinical trial designed to compare the efficacy and safety of JS207 combined with JS007 versus toripalimab combined with bevacizumab for first-line advanced hepatocellular carcinoma. The study plans to enroll 560 subjects, with the primary endpoints being progression-free survival (PFS) and overall survival (OS).