On April 29, 2024 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported that responses regarding the status of the Corrective and Preventive Actions (CAPAs) plan have been submitted to the U.S. Food and Drug Administration (FDA) (Press release, Carsgen Therapeutics, APR 29, 2024, View Source [SID1234642448]). This submission is related to the observations identified in the Form 483 issued after the FDA inspection in December 2023 of our clinical manufacturing site in Durham, North Carolina. All relevant works are progressing smoothly according to the previously committed timetable.

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