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2024Year9Month25Date, imbioray submittedIBR900Cell Injection Receives Approval from the National Medical Products Administration (NMPA) has received implied permission for clinical trials (Notice Number:2024LP02169）。IBR900The injection solution is independently developed by Imbioray.1Biological products, areAllogeneic Healthy DonorPBMCSource-derived, non-genetically modified, universal off-the-shelf with excellent tumor cell killing abilityNKCellProduct. Indications areBCell lymphoma.
IBR900Is an allogeneic healthy donorPBMCSource-derived, non-genetically modified, universal off-the-shelf with tumor cell-killing capabilityNKCells. Young and Healthy DonorPBMCInNKCells can be activated through Imbioray's proprietary culture process, which enhances their immune regulation and tumor-killing capabilities without prior sensitization, with no observed cytokine release syndrome (CRS）、Neurotoxicity （ICANS`) and allograft rejection (`GVHD), with significant safety advantages.IBR900Cells can pass throughNKDirect cytotoxic effects, secretion of cytokines, induction of apoptosis, and other pathways to kill hematological or solid tumors, while also enabling destruction throughADCCEffect combined with monoclonal antibodies to kill tumor cells positive for the corresponding target.In the early non-registered clinical studies,IBR900The cell injection demonstrated extremely high safety, with a total of11Example patients receivedIBR900Cell Injection Treatment, Total Completion82Per cycleIBR900No treatment discontinuations due to adverse reactions were observed, and no cases of cytokine storm or infection were reported among the patients. This demonstratesIBR900With extremely high safety and powerful tumor cell killing capability.One of the cases73Year Diffuse LargeBA patient with cellular lymphoma (Stage Ⅳ) who, unable to tolerate chemotherapy, receivedIBR900Cell Injection CombinedCD20Monoclonal Antibody Therapy andIBR900Cell Injection Monotherapy (Monotherapy Exceeding6months), the best efficacy was partial remission, and as of the publication date, it was still in remission, with a progression-free survival period reaching12months, and no adverse reactions occurred during the medication process.BCell lymphoma isBSolid tumors occurring in cells, including Hodgkin's lymphoma (HL) and Non-Hodgkin's Lymphoma (NHL) and other classifications.BThe pathological mechanisms of lymphoma are complex and diverse, with high heterogeneity, rapid disease progression, and a high degree of malignancy, posing a serious threat to patients' quality of life and safety. Such as diffuse largeBCell Lymphoma (DLBCL) is a group of malignant tumors with significant heterogeneity in clinical manifestations and prognosis, among other aspects. The company plans to first target recurrence./RefractoryBRegistration clinical studies were conducted in patients with lymphoma, considering the company's product.Excellent Results in Safety and Efficacy, especially for those over the age of65Years old, or patients who are intolerant or have failed treatment due to physical constitution reasons.New HopeThe company also plans to conduct research in various fields such as solid tumors, autoimmune diseases, neurological disorders, and skin-related conditions.The company has professional and completeNKThe entire chain of cell product preparation andGMPPreparation Center, with strong research and development capabilities, can effectively support the development and iteration of the company's products. It has the largest scale in the world.NKCell Expansion Process, from50L-100LSingle-batch culture systems are gradually being upgraded. Initially,50LEach batch1000Cells increased to per batch2000Million cells, currently we100LThe cultivation volume per batch can reach5000Over 100 million. Globally leadingNKCell culture process ensures good stability between batches and strong repeatability. Large-scale and high-qualityNKThe cultivation process can simultaneously reduce costs and benefit a larger patient population.Imbioray is a clinical-stage and venture-backed innovative biopharmaceutical company, primarily focused on cutting-edge global tumor immunotherapy, as well as immunological diseases, chronic conditions, andCNSDevelopment of innovative immunotherapy drugs for diseases. Dr. Zhenwei Miao, founder of Imbioray2016Returned to China to start a business in the year, establishing imbioray based onNKThe direction of developing off-the-shelf universal cell drugs. Imbioray has internationally original4Large Core Technology Platform Accelerates Company's Original Innovation, with Internationally Leading Independent Intellectual Property Rights, and Large-Scale Closed Culture of PBMCs from Young and Healthy DonorsNKAdvanced Cell Technology. Based on proprietary antibody conjugationNKCell Platform Technology DevelopmentIBR854、IBR733、IBR822And several other off-the-shelf cell therapy products. Currently, the world's first innovative treatment for advanced solid tumorsIBR854Cell Injection to Enter Phase II Clinical Trials and the World's First Targeting Acute Myeloid LeukemiaIBR733Cell Injection Has EnteredIPhase II Clinical Trial, Second Dose Group Stage. Targeting Advanced Solid Tumors.IBR822It is Imbioray's third antibody.-NKCell coupling drugs have started registration clinical trials in September this year.IBR900It is the fourth off-the-shelf universal NK cell product from Imbioray to receive clinical tacit approval from the CDE, with the main target population for clinical application being65Years old and aboveBCell LymphomaOr tumor patients who are intolerant or have failed existing treatments.Imbioray has multiple products at different stages of development.NK Cell Products.Imbioray Company, with patients' needs at its core and clinical value as its orientation, adheres to the concept of "The Light of Immunotherapy, Igniting New Hope for Life," and is committed to becoming a global leader.NKThe Pioneer and Leader in Cell Immunotherapy.Source: imbioray
