Junshi Biosciences Announces FDA Approval of Investigational New Drug Application for Anti-CD112R Monoclonal Antibody for Treatment of Advanced Solid Tumors

Shanghai Junshi Biosciences Co., Ltd a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its anti-CD112R monoclonal antibody (TAB009/JS009) for the treatment of advanced solid tumors. TAB009/JS009 is a recombinant humanized IgG4 monoclonal antibody against human CD112R developed independently by Junshi Biosciences, for the treatment of advanced malignant tumors. CD112R, also known as PVRIG (Poliovirus receptor-related immunoglobulin domain-containing protein), is a new immune checkpoint pathway discovered by the company. Dr. Sheng Yao, Senior Vice President of the company, is one of the discoverers of this novel pathway. CD112R is a single-pass transmembrane protein of the PVR family, mainly expressed on T cells and NK cells, and is significantly upregulated upon activation. CD112R and TIGIT share a common ligand, CD112, which is expressed on the surface of antigen-presenting cells and certain tumor cells. CD112R can inhibit the anti-tumor effect of T cells and NK cells after ligand engagement. TAB009/JS009 binds specifically to CD112R with high affinity and effectively blocks the interaction between CD112R and its ligand CD112, thereby facilitating the activation and proliferation of T cells and NK cells and enhancing the immune system

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