The EMA’s decision provides AbelZeta with enhanced regulatory support, including early scientific advice to accelerate the development of the autologous anti-CD20/BCMA product. By targeting both autoreactive B cells and antibody-producing plasma cells, the therapy aims to induce a durable immune reset in patients who have failed to respond to conventional standards of care.
In section Releases
AbelZeta’s C-CAR168 Gains EMA PRIME Status for Lupus Treatment
The European Medicines Agency has granted PRIME designation to C-CAR168, a dual-target CAR-T therapy developed by AbelZeta Pharma. This regulatory milestone acknowledges the potential of the treatment to address refractory Systemic Lupus Erythematosus and Lupus Nephritis, marking a shift in how cell therapies are applied to severe autoimmune conditions.
Tony Liu, Chairman and CEO of AbelZeta, described the designation as a validation of the company's scientific platform and its transition from oncology into immunology. The move follows a similar regulatory endorsement in the United States, where the FDA granted C-CAR168 Regenerative Medicine Advanced Therapy status in May 2025. With centers in Rockville and Shanghai, the firm is now positioning the therapy to address a broader range of indications, including progressive multiple sclerosis.
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