Hangzhou Qihan Biotech Co., Ltd. ("Qihan" or "Qihan Biotech" or "the Company"), an industry leader in applying multiplexable genome editing technology to cell therapies and organ transplantation, today announced that its internally developed universal dual-target CAR-T therapy, QT-019B, has officially received both Regenerative Medicine Advanced Therapy (RMAT) designation and Breakthrough Therapy Designation (BTD) from the U.S. FDA. This achievement marks another significant milestone for QT-019B following its receipt of Fast Track Designation (FTD) from the FDA in November 2025.

QT-019B is now among a select group of cell therapy products worldwide to have secured all three of the FDA’s highest-level expedited development and review designations - FTD, RMAT, and BTD. It is also the first cell therapy product developed in China to earn this FDA “triple crown” of accelerated regulatory designations.

What Is RMAT? — The “VIP Fast Lane” for Regenerative Medicine

The Regenerative Medicine Advanced Therapy (RMAT) designation is an FDA expedited program specifically designed for regenerative medicine products, including cell therapies and gene therapies.

Receiving RMAT designation provides several important benefits, including:

• Closer collaboration with the FDA through early and frequent interactions with the review team.
• Rolling review, enabling the submission and review of application components on an ongoing basis and potentially accelerating the regulatory review process.
• Eligibility for Priority Review and Accelerated Approval, which may facilitate earlier patient access to transformative therapies.

What Is BTD? — The FDA's Highest-Level Expedited Program for Breakthrough Therapies

The Breakthrough Therapy Designation (BTD) is the FDA’s highest-level expedited development program for therapies intended to treat serious or life-threatening diseases and that may demonstrate substantial improvement over existing treatment options.

Compared with Fast Track Designation, BTD provides enhanced regulatory support, including:

• Direct involvement from senior FDA leadership beginning as early as Phase I clinical development.
• Comprehensive guidance throughout the product development and regulatory review process.
• Eligibility for Rolling Review and Priority Review, which may help accelerate development and facilitate earlier approval.

Why Is This Dual Designation So Significant?

Both RMAT and BTD are reserved for therapies that have the potential to provide meaningful improvements over existing treatment options. The granting of both designations reflects the FDA’s recognition of QT-019B’s promising early clinical profile, supported by encouraging efficacy and safety data. This dual designation not only reinforces the clinical promise of QT-019B, but also underscores the growing global competitiveness of China’s independently developed universal cell therapy technologies, which are increasingly emerging at the forefront of innovation in the field.

“The achievement of all three of the FDA’s premier expedited development designations for QT-019B underscores both the strength of our scientific platform and the compelling clinical potential of this program,” said Dr. Luhan Yang, Founder and Chief Executive Officer of Qihan Biotech. “We are committed to working closely with the FDA to accelerate development and bring safe, effective, and accessible universal cell therapies to patients around the world as quickly as possible.”