The board of directors of Shanghai Junshi Biosciences Co., Ltd. announced that, the Company has received the Notice of Approval for Clinical Trial issued by the National Medical Products Administration. The investigational new drug application for the JS009 injection (project code: "TAB009/JS009") has been approved. TAB009/JS009 is a recombinant humanized monoclonal antibody against human CD112R
developed independently by the Company, 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. Yao Sheng, an
executive Director, deputy general manager and core technical personnel 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 antitumor 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's ability to kill tumor cells. In April 2022, the investigational new drug application for
TAB009/JS009 for the treatment of advanced solid tumors was approved by the U.S. Food and
Drug Administration (FDA). As of the date of this announcement, no product targeting CD112R
has been approved for marketing globally.