Shanghai – October 17, 2026 -- The U.S. Food and Drug Administration has granted Orphan Drug Designation to GT801, the lead in vivo CAR-T candidate of Vivacta Biotechnology (Shanghai) Co., Ltd., for autoimmune hemolytic anemia (AIHA). Vivacta Bio was spun out of Beijing Grit Biotherapeutics' in vivo CAR-T platform on June 25, 2025.