Recently, the clinical trial application for Imbioray's IBR900 Cell Injection has been accepted by the National Medical Products Administration (Acceptance No.: CXSL2400441). IBR900 Injection is a Class 1 biological product independently developed by Imbioray. It is an allogeneic, non-genetically modified universal NK cell product derived from healthy donor PBMCs, with the ability to kill tumor cells. The indication is B-cell lymphoma.

Regarding B-cell Lymphoma:

B-cell lymphoma is a solid tumor originating from B cells, including subtypes such as Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL). The pathogenesis of B-cell lymphoma is complex and diverse, with high heterogeneity and rapid disease progression, posing a significant threat to patients' quality of life and survival. Diffuse large B-cell lymphoma (DLBCL), for instance, is a group of malignant tumors with considerable heterogeneity in clinical manifestations and prognosis. Its incidence accounts for 31%-34% of non-Hodgkin lymphoma (NHL), generally exceeding 40% in Asian countries. If DLBCL patients are treated with the current standard immunochemotherapy regimen, the 5-year progression-free survival rate can reach 60-65%, and 40-50% of patients can achieve a cure. However, approximately 10%-15% of patients exhibit primary refractoriness to first-line standard treatments, while 20-25% of patients experience disease relapse after remission. These patients have a very poor prognosis, creating an urgent need for new drugs to meet treatment demands.

About IBR900 Cell Injection:

IBR900 is an allogeneic, non-genetically modified universal NK cell derived from healthy donor PBMCs, with the ability to kill tumor cells. NK cells in healthy donor PBMCs can be activated through imbioray's proprietary culture process, enhancing their immune regulatory functions and enabling them to kill tumors without prior sensitization. No cytokine release syndrome (CRS), neurotoxicity (ICANS), or graft-versus-host disease (GVHD) has been observed, offering significant safety advantages. IBR900 cells can kill hematologic malignancies or solid tumors through direct cytotoxic effects of NK cells, secretion of cytokines, and induction of apoptosis. Additionally, they can target and kill tumor cells positive for specific antigens via antibody-dependent cellular cytotoxicity (ADCC) in combination with monoclonal antibodies.

tiNK Cells Are Non-Gene-Edited, Naturally Immune-Primed Natural Killer (NK) Cells Based on Innate Killing Mechanisms. Through Special Cytokines, the Expression of Activating Receptors Is Enhanced to Strengthen the Ability to Kill Tumors. The Mechanism of Action Includes Both Direct and Indirect Killing Mechanisms of NK Cells. Indications Cover Various Solid Tumors, Hematological Malignancies, Autoimmune Diseases, Chronic Conditions, and Neurodegenerative Diseases.

The company owns a professional and complete NK cell product preparation chain as well as a GMP preparation center, with strong research and development capabilities that effectively support the development and iteration of its products. It has the world's largest NK cell expansion process, gradually upgrading from a 50L-100L single-batch culture system. Initially starting at 50L per batch producing 100 billion cells, it has now increased to 200 billion cells per batch. Currently, our 100L culture volume can reach over 500 billion cells in a single batch. The globally leading NK cell culture process ensures excellent stability and repeatability between batches. This large-scale, high-quality NK culture process also reduces costs, benefiting more patients.

   About Imbioray

Imbioray is a clinical-stage and venture capital-backed innovative biopharmaceutical company, primarily focused on the development of novel immunotherapies for cutting-edge global oncology treatments, as well as non-oncology areas such as immune-related diseases, chronic conditions, and CNS disorders. Dr. Zhenwei Miao, the founder of Imbioray, returned to China in 2016 to start his entrepreneurial journey, establishing the direction of developing off-the-shelf NK cell-based therapeutics. Imbioray has four internationally unique core technology platforms that accelerate the company's original innovation, along with advanced processes for large-scale, closed-system in vitro NK cell cultivation that lead globally. Based on its proprietary antibody-conjugated NK cell platform technology, Imbioray has developed several universal off-the-shelf cell therapy products, including IBR854, IBR733, and IBR822. Currently, IBR854, the world’s first cell injection for advanced solid tumors, and IBR733, the world’s first cell injection targeting acute myeloid leukemia, have both entered Phase I clinical trials. The dosing for the first cohort of IBR733 has been fully completed, with patients showing good responses. IBR822 is the third antibody-conjugated NK cell drug approved for clinical trials by Imbioray and the second IND product for solid tumor treatment to receive regulatory clearance, with registration clinical trials set to begin soon. Imbioray also has multiple NK cell products at various stages of development.

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