Qihan Biotech's QT-019B Receives FDA RMAT and BTD

Qihan Biotech

16 June 2026 - Hangzhou Qihan Biotech today announced that its internally developed universal dual-target CAR-T therapy, QT-019B, has officially received both regenerative medicine advanced therapy designation and breakthrough therapy designation from the US FDA. 

This achievement marks another significant milestone for QT-019B following its receipt of fast track designation from the FDA in November 2025.

Read Qihan Biotech press release

Michael Wonder

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Michael Wonder