HANGZHOU, China, June 11, 2026
Qihan Biotech announced that its investigational universal dual-target CAR-T therapy QT-019B has received both the U.S. Food and Drug Administration (FDA) Regenerative Medicine Advanced Therapy (RMAT) designation and Breakthrough Therapy Designation (BTD). The achievement follows the therapy’s earlier receipt of Fast Track Designation (FTD) in November 2025, making QT-019B one of a limited number of cell therapy candidates globally to secure all three of the FDA’s highest-priority expedited development pathways. The milestone also establishes QT-019B as the first China-developed cell therapy to achieve this regulatory “triple crown,” highlighting the growing global influence of China’s biotechnology innovation sector.
FDA Recognizes Promising Clinical Potential of QT-019B
The FDA’s RMAT and BTD programs are reserved for therapies targeting serious or life-threatening diseases that demonstrate the potential to offer substantial advantages over currently available treatments. The dual designation reflects the agency’s recognition of QT-019B’s encouraging early clinical efficacy and safety profile. RMAT status provides opportunities for intensified FDA engagement, rolling review, and potential accelerated approval pathways, while BTD offers direct involvement from senior FDA officials and enhanced regulatory guidance throughout clinical development. Together, these programs are designed to accelerate the development and review of transformative therapies, potentially bringing innovative treatments to patients faster than traditional regulatory pathways.
Universal Dual-Target CAR-T Designed to Overcome Key Challenges
QT-019B is an off-the-shelf allogeneic CAR-T cell therapy engineered using Qihan Biotech’s multiplex genome-editing platform. Derived from healthy donor cells, the therapy simultaneously targets both CD19 and BCMA, enabling it to identify and eliminate cancer cells expressing either antigen. The product has been further enhanced through gene-editing technologies that remove the T-cell receptor (TCR) to reduce the risk of graft-versus-host disease (GvHD). Additionally, Qihan employs advanced hypoimmunity engineering to minimize recognition by a patient’s immune system, helping the modified CAR-T cells evade immune rejection, improve persistence, and maintain therapeutic activity. This next-generation design aims to address several limitations associated with conventional autologous CAR-T therapies, including manufacturing complexity, treatment delays, and limited scalability.
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Strengthening Global Leadership in Universal Cell Therapy
The FDA’s latest decision represents a significant validation of Qihan Biotech’s scientific platform and long-term vision for universal cell therapies. Company leadership stated that obtaining all three expedited FDA designations demonstrates both the strength of its multiplex genome-editing capabilities and the therapeutic promise of QT-019B. Founded by Dr. Luhan Yang and Dr. George Church, Qihan Biotech is advancing a pipeline of off-the-shelf cell therapies through the integration of synthetic biology, multiplex gene editing, hypoimmunity engineering, and scalable GMP manufacturing technologies. With regulatory momentum now accelerating for QT-019B, the company is positioned to further expand its presence in the rapidly evolving cell therapy landscape while working toward the development of safer, more accessible, and globally available treatments for patients with severe diseases.
Source: Qihan Biotech press release
