Bioheng Biotech received orphan drug designation from U.S. FDA

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Nanjing Bioheng Biotech Co., Ltd. Announced UCAR T cell therapy product targeting CD7, code CTD401, received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of T-cell acute lymphoblastic leukemia (T-ALL).

“CTD401 is the first innovative product based on our next-generation generic CAR-T technology platform. It has excellent efficacy and superior safety in exploratory clinical studies,” said Dr. JiangTao Ren, Co-founder and Chief Scientific Officer of Bioheng.



Dr. JiangTao continues, “Orphan drug accreditation not only reflects the confidence of the international authority FDA on CTD401, but also is an important milestone of Bioheng gradual globalization.”

CTD401 is a universal CAR-T (UCAR-T) cell therapy product developed by Bioheng for the treatment of patients with T-ALL. The product is prepared by collecting peripheral blood mononuclear cells (PBMC) from healthy donors, using a virus encoding a CD7 CAR gene for transduction, and using CRISPR/cas9 technology to knock out key genes.

The Orphan Drug Designation program

SOURCE: PRNewswire

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