CARsgen Therapeutics Holdings Ltd (HKG: 2171), a specialist in chimeric antigen receptor (CAR)-T cell therapies based in China, has announced the filing of its Corrective And Preventive Actions (CAPAs) report with the US Food and Drug Administration (FDA). This follows a previous request by the FDA in December last year for CARsgen’s US subsidiary, CARsgen Therapeutics Corporation, to place clinical studies for its CAR-T products CT053, CT041, and CT071 on hold.
The company was instructed to halt the clinical trials until the FDA completed an inspection of its manufacturing facility in Durham, North Carolina, and reached a resolution. In response, CARsgen committed to conducting a thorough review and enhancement of its facilities in accordance with current Good Manufacturing Practice (cGMP) standards and to work closely with the FDA to resolve any issues that may arise.- Flcube.com
