FDA Clears Investigational NDA for IASO208
Ms. Jinhua Zhang, Founder, Chairwoman, and CEO of IASO Bio, said: “The FDA’s clearance of the IND application for IASO208 represents an important milestone for InTelliCAR™, IASO Bio’s proprietary in vivo CAR-T platform, and marks the entry of China-originated cell therapy technologies into the global race in the in vivo CAR-T field. Leveraging the proprietary InTelliCAR™ platform, IASO Bio has established a pipeline of multiple in vivo CAR-T product candidates spanning hematologic malignancies, autoimmune diseases, and solid tumors, with several of these products already in the IND-enabling stage. The FDA’s clearance of IASO208 based on early IIT data from China reflects the regulator’s recognition of the high quality of China’s IIT clinical data, and lays a solid foundation for the international development of the platform’s pipeline. Going forward, we will continue to advance the clinical development of the InTelliCAR™ platform pipeline to accelerate global patient access to China-originated cell therapies.”
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