InnoCare Pharma Subsidiary Yingbairui's First-in-Class Off-the-Shelf CD33/CLL1 Bispecific CAR-raNK Therapy IBR733 Granted IND Approval by CDE for Relapsed/Refractory AML

December 18Imbioray (Hangzhou) Biopharmaceutical Co., Ltd. (hereinafter referred to as "Imbioray") has received the CDE clinical trial implied permission for its IBR733 cell injection, with the indication beingAcute Myeloid Leukemia (AML).

IBR733 Cell Injection isFor Relapsed/Refractory Acute Myeloid Leukemia（Acute myeloid leukemia，AML）IndicationsInThe World's First CD33 and CLL1 Dual-Target Antibody-Conjugated NK Product Approved for IND Clinical ResearchIt uses imbioray's proprietary specific antibody CD33/CLL1, which targets tumor antigens, to chemically conjugate with NK cells via a linker. This is an off-the-shelf, universal NK cell product that does not involve viral vectors or genetic modification, offering high safety and potent tumor cell killing ability.

Acute Myeloid Leukemia（Acute myeloid leukemia，AML）Is aMalignant Diseases of Myeloid Hematopoietic Stem/Progenitor CellsThe disease progresses rapidly, with severe and acute conditions and a poor prognosis. AML has always been one of the treatment challenges among hematologic malignancies, lacking effective therapeutic options. For decades, chemotherapy has dominated drug treatments for AML, with a 5-year survival rate below 20%. Despite advances in cytogenetics and molecular biology, which have deepened the understanding of AML's underlying pathogenic mechanisms and spurred the development of targeted therapies, these drugs are suitable for a limited patient population and extend overall survival only modestly. Most patients experience relapse or bone marrow suppression after treatment.

Clinical sample studies have shownIn 90% of AML patients' tumor tissues, CD33 is expressed, but it is not expressed or is lowly expressed in normal tissues. CLL1 is expressed on most AML's CD34+CD38- stem cells but not on normal individuals' CD34+CD38- stem cells. CLL1 is a marker antigen of leukemia stem cells and has potential targeted therapeutic value. Imbioray’s IBR733 is an off-the-shelf universal conjugated antibody CD33/CLL1 dual-target NK cell product. By targeting CD33 and CLL1, it can simultaneously attack AML cells and leukemia stem cells, the latter being the main factor leading to AML recurrence. This effectively enhances the efficacy of AML treatment while reducing the safety risks of single-target therapies and tumor immune escape.

About Imbioray

Imbioray (Hangzhou) Biopharmaceutical Co., Ltd. mainly focuses on the development of cutting-edge CAR-NK cell therapy drugs globally, committed to addressing unmet clinical needs in the treatment of tumors and immune-related diseases. Imbioray has independently developed internationally leading tiNK@, CAR-raNK@ cell technology platforms and multiple universal allogeneic NK and CAR-NK cell therapy products. Currently, several new drugs for solid tumors and blood cancers are being advanced into clinical stages.