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2024Year2Month7Day，SimnovaSelf-developed targetedCD19Chimeric Antigen Receptor Gene-ModifiedNKCell Injection Solution Officially Approved by the Center for Drug Evaluation of the National Medical Products Administration (NMPA)CDE) has received clinical tacit approval, with indications for moderate to severe refractorySystemic Lupus Erythematosus（SLE）。This isSLEIndications inThe First in ChinaGeneral TypeNKProduct ApprovalIND, Clinical Progress EvenExpected to become a global leader。
Systemic Lupus Erythematosus (SLE) is a complexAutoimmune Diseases, which can cause damage to multiple organs and tissues throughout the body. It is estimated that currently, there are approximately100Ten ThousandSLEPatient. In recent years,SLEAlthough the long-term survival of patients has improved, the inevitable recurrence of the disease and the resulting irreversible organ damage remain.SLEAn important cause of patient death.SLEThe mortality rate of patients is3-4Times. Therefore, there is an urgent need for innovative treatment methods to achieve continuous relief of disease symptoms, control organ damage, and improve patients' long-term survival.The Development of Cell TherapySLEPatients bring a brand-new, safe and effective treatment option.Cell therapy resets the immune system, offering the potential for long-term relief for patients with severe autoimmune diseases.Simnova Develops Universal Type Through Research and DevelopmentCAR-NKTherapy, significantly reduces the economic burden on patients compared to other innovative cell therapy products and is readily available. AdditionallyNKThe safety advantages of cellular protrusions allowNKThe therapy is expected to stand out in the evolving field of autoimmune diseases. During the product development process, Simnova adopted an innovative design with independent intellectual property rights.CARStructure, demonstrated superior performance in preclinical studies compared to similarCARDesign more effective activity. Meanwhile, Simnova has mature and stable large-scale universal typeNKCell PreparationCMCAbility.NKofCARThe transduction efficiency, amplification level, and cell viability after cryopreservation and recovery have reached industry-leading levels.Simnova is a cell therapy biotechnology company at the clinical development stage. Founded in2019Year, originally a subsidiary of Simnova,2021Year split for independent operation. Simnova has research centers in Shanghai, China, and Boston, USA. The company is currently focusing on developing globally competitive universal-typeCAR-NK, and is also actively promoting innovativeBiTE CAR-TTechnical Platform for Clinical Research and Application of Solid Tumors, Meanwhile Simnova Also Cooperates with Star Biotechnology CompaniesORNA's collaboration layout is based on circularmRNAand the development of next-generation universal in vivo cell therapy products with targeted delivery platforms,This technology will becomeCARNKAnother disruptive universal cell therapy drug format with significant potential for wide application in treating tumors, autoimmune diseases, and other disease areas.
