Qihan Biotech cell therapy makes history with three expedited FDA designations (opens in new tab)

Hangzhou Qihan Biotech announced that its off-the-shelf, dual-target allogeneic CAR-T therapy QT-019B has received Regenerative Medicine Advanced Therapy and Breakthrough Therapy designations from the U.S. FDA. The awards follow a Fast Track designation granted in November 2025, placing QT-019B among a small group of cell therapies that hold all three of the FDA’s top expedited […] The post appeared first on <a href="

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