Qinghui Lianuo's Off-the-Shelf Allogeneic CAR-γδ T Cell Therapy QH104A Receives IND Approval in China for CNS Malignancies Following U.S. Clearance

Obtaining clinical trial approvals from the U.S. FDA and China CDE within four months indicates that the preclinical research data, production processes, and quality systems of QH104A have all met the consistent standards of international regulatory authorities. This is not only a high recognition of the product's innovative potential but also strong evidence that Qinghui Lianuo's R&D system has the capability to compete globally, laying a solid foundation for subsequent global synchronized development.

"Malignant tumors of the central nervous system" have a poor prognosis and limited treatment options. QH104A combines the innate immune recognition properties of γδ T cells with the precise targeting ability of CAR technology, enabling deeper and more sustained tumor killing and control. Additionally, the "off-the-shelf" design offers advantages in drug accessibility, providing a novel solution to break the clinical deadlock for malignant tumors of the central nervous system.

The realization of QH104A's "off-the-shelf universal" design relies on the efficient and stable production process system independently developed by Qinghui Lianuo. This platform has overcome key bottlenecks in large-scale preparation and cost control for allogeneic cell therapies, serving as the core guarantee to make "off-the-shelf" cell treatment drugs accessible and affordable. The successful dual filing of QH104A in China and the United States reflects regulatory recognition of the platform’s potential and reliability, laying a solid foundation for the development of more product varieties in the future.