Qinghui Lianuo Announces FDA IND Approval for QH104A, the World’s First Allogeneic Anti-B7H3 CAR-γδ T Cell Therapy for Recurrent or Progressive High-Grade Gliomas

May 16, 2025 15:40 CST Updated 15:40

Unicet Biotech

Developer of γδ T Cell Therapeutics

Recently, a company within the Zhongguan Village Life Science ParkQinghui LianuoAnnounced that its independently developedWorld's First Allogeneic Universal CAR-γδ T Cell Injection Targeting B7H3QH104AOfficially received the approval from the U.S. Food and Drug Administration (FDA) for a new drug clinical trial (IND), for the treatment of Recurrent or Progressive High-grade Gliomas. This is the first regulatory clinical trial approval obtained by Qinghui Lianuo, marking a key milestone for the company in transitioning from original innovation to global clinical development.

QH104A Injection is the world's first CAR-γδ2 T cell candidate drug to receive FDA IND approval, and also the only allogeneic CAR-T therapy approved by the FDA for clinical trials targeting malignant glioma, highlighting the leading position of Chinese innovative pharmaceutical companies at the forefront of global cell therapy development.

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Tackling the Treatment Dilemma of the "King of Cancers"

Two-Decade Clinical Stalemate May See a Breakthrough

High-grade gliomas, as the most aggressive malignant tumors in the central nervous system, have always been a "tough challenge" in the field of tumor treatment. Glioblastoma, which has the highest incidence rate (accounting for about 50% of high-grade gliomas), leaves patients with...The median overall survival is only 14-16 months, with an expected survival of just 6-8 months after recurrence, and a five-year survival rate of less than 7%.Traditional therapies struggle to break through the efficacy bottleneck due to challenges such as the blood-brain barrier and high tumor heterogeneity.

QH104A Cell DrugPioneering integration of the natural anti-tumor properties of γδ T cells with the precise targeting advantages of CAR-T technology, Data from investigator-initiated clinical trials (IIT) already conducted show that it can significantly extend patient survival, with the potential to break the two-decade stagnation in breakthrough therapies in this field and bring hope to glioblastoma patients worldwide.

Set New Standards in Cell Therapy

Off-the-Shelf Drugs Benefit Patients Worldwide

QH104A relies on the fully enclosed semi-automated production process system independently developed by Qinghui Lianuo.A breakthrough in the large-scale preparation of cellular drugs significantly reduces the production cost per dose.; At the same time, its "allogeneic universal" designBreakthrough in personalized preparation limitations: drugs can be stored frozen in liquid nitrogen for the long term, forming an "off-the-shelf" drug reserve, significantly shortening patient waiting time and avoiding delays in treatment.

The approval of QH104A for clinical trials represents the regulatory authority's recognition of Qinghui Lianuo's scalable allogeneic cell drug production process based on γδ T cells. This process can be expanded to more candidate products, providing an industrial model for developing more affordable and accessible cell drugs for patients.

FDA Approval of QH104A Cell Injection for Clinical Trials Marks a Significant Milestone in Qinghui Lienal's Path of Innovation. Moving forward, the company will accelerate clinical trials for this product in malignant glioma indications while actively exploring its potential applications in the treatment of other solid tumors. Qinghui Lienal will continue to focus on the γδ T-cell field, striving to bring more self-developed universal γδ T-cell therapies to benefit patients worldwide as soon as possible.