FDA Grants Orphan Drug Status to Vivacta Bio's In Vivo CAR-T GT801
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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.
Designation opens tax credits, fee exemption and seven-year exclusivity
Sponsors of designated products may be eligible for tax credits on qualified clinical trial expenses and an exemption from marketing application user fees. They may also receive seven years of orphan drug market exclusivity after marketing approval, subject to applicable requirements.