YingBaiRui's Second Solid Tumor-Targeting Product, IBR822 Cell Injection, Receives IND Acceptance from CDE

Yusheng Biotech warmly congratulates Imbioray on this significant milestone! In this project, Yusheng Biotech provided comprehensive technical services and validation support related to rapid mycoplasma NAT detection, including MycAway.^TMThe Mycoplasma qPCR Detection Kit has been fully validated for its specificity, limit of detection, and robustness according to EP 2.6.7 and JP G3, while also covering the types of Mycoplasma strains required for validation by USP, WHO, and ChP. The kit's performance complies with regulatory standards in China and abroad as well as international authoritative institution standards, facilitating the smooth acceptance of the project's clinical trial application by the National Medical Products Administration.

IBR822 Cell Injection is an antibody-NK cell conjugate drug. A full-length monoclonal antibody targeting human Trop2 antigen is chemically conjugated, via a linker, to NK cells derived from the peripheral blood of allogeneic healthy donors expanded in vitro. This results in a non-viral, non-genetically modified antibody-NK conjugate drug (Trop2 CAR-raNK) that specifically targets the Trop2 antigen and has the ability to kill tumor cells.

Imbioray is committed to addressing the unmet clinical needs in the treatment of tumors and immune-related diseases, primarily focusing on the development of cutting-edge NK cell therapies and cell engager products globally. Imbioray has an internationally unique tiNK and CAR-raNK cell technology platform, along with advanced processes for large-scale, closed-system, in vitro cultivation of NK cells. Based on its proprietary platform technologies, Imbioray has developed several off-the-shelf cell therapy products such as IBR854 and IBR733. Multiple investigator-initiated clinical trials (IITs) have been conducted, which preliminarily demonstrated safety and efficacy. Currently, the IBR854 cell injection has progressed to Phase I clinical trials, and several other novel drugs targeting solid tumors and hematologic malignancies are gradually advancing.