Qihan Biotech’s QT-019B Achieves FDA 'Triple Crown': First Chinese Cell Therapy to Secure FTD, RMAT, and BTD Designations
Qihan Biotech
Gene Editing Technology Developer
Hangzhou, China, June 11, 2026— Hangzhou Qihan Biotech Co., Ltd. announced today that its independently developed universal dual-target CAR-T product, QT-019B, has officially received dual authoritative designations from the U.S. FDA: Regenerative Medicine Advanced Therapy (RMAT) and Breakthrough Therapy Designation (BTD).
This marks another milestone following the acquisition of FDA Fast Track Designation (FTD) in November 2025,QT-019B has become one of the rare candidates globally to simultaneously receive FTD,RMAT, a cell therapy product that has secured all three of the FDA’s highest-tier accelerated review pathways: Breakthrough Therapy Designation (BTD). This marks the first cell therapy product from China to achieve the “grand slam” of the FDA’s three major accelerated review pathways.
What Is RMAT? — The "VIP Lane" for Regenerative Medicine
RMAT is an accelerated pathway established by the FDA specifically for regenerative medicine therapies, such as cell therapy and gene therapy. Receiving RMAT designation means:
➤Early High-Frequency Communication：Establish a closer dialogue mechanism with the FDA review team
➤Rolling Review：Submissions can be made in batches, significantly shortening the review cycle.
➤Priority Review/Accelerated Approval：Promising Faster Market Access to Benefit Patients
What isBTD? — "Full-Course Escort" for Breakthrough Therapies
BTD is the highest-level expedited pathway established by the FDA for drugs treating serious conditions that demonstrate significantly superior efficacy compared to existing therapies. Compared with FTD, BTD provides more intensive review support:
➤Full Executive Involvement：FDA Senior Management Engages Deeply Starting from Phase I Clinical Trials
➤Full-Process Guidance：From R&D to market launch, every step is safeguarded by the FDA’s professional team.
➤Rolling Review + Priority Review：Dual Acceleration: Getting Quality Medications to Patients Faster
Why Is "Dual Certification" So Significant?
RMAT and BTD are both based on"Significantly superior to existing treatments"as a prerequisite. Dual recognition implies that the early clinical data of QT-019B inEfficacy and SafetyBoth aspects have received authoritative endorsement from the FDA, marking China'sUniversal Cell TherapyIndependent R&D capabilities have reached the global first tier.
Founder and CEO of Qihan BiotechDr. Luhan Yang“It is significant that QT-019B has successively obtained three highest-level accelerated designations from the FDA. This not only affirms the Qihan team’s years of technological accumulation but also demonstrates the FDA’s high recognition of our product’s innovativeness and clinical potential. We will continue to optimize our clinical development strategy and advance product R&D under the highest standards, so that safe and effective universal cell therapy products can be made available to patients worldwide at an earlier date.”
[About Qihan Biotech]
Qihan Biotech is a clinical-stage biotechnology company headquartered in Hangzhou, China, co-founded by Dr. Lushan Yang and Professor George Church. The company advances the clinical translation of universal cell therapies through multiplex gene editing, synthetic biology, and scalable GMP manufacturing systems. Qihan Biotech’s vision is to create a world where cell and organ therapies are accessible to every patient. For more information about Qihan Biotech, please visit the company’s website at www.qihanbio.com.
Responsible Editor: Liu Li
Disclaimer: This article is reposted from Yaozhi.com. The copyright of the images and text belongs to the original authors. The purpose of this repost is to convey more information, which does not represent the views of this platform. If there are any issues related to the content, copyright, or other matters, please leave a message on this platform, and we will handle it as soon as possible.