Qinghui Liannuo's Universal γδ T-cell Therapy QH104A Receives FDA Orphan Drug Designation for Malignant Glioma

Malignant glioma is a malignant tumor originating from glial cells in the nervous system and is one of the most common malignant tumors in the cranium, including types such as glioblastoma, astrocytoma, and oligodendroglioma. Among these, glioblastoma (Glioblastoma, GBM) is the predominant type, which is highly prone to recurrence after treatment and associated with extremely poor prognosis. The five-year survival rate is only 6.8%. There is an urgent clinical need to develop new therapeutic strategies to improve the survival rate and quality of life for patients with malignant glioma.

QH104A is the world's first universal allogeneic CARγδ T-cell therapy targeting B7H3. Its innovation achieves precise tumor killing through a dual mechanism: on one hand, recognizing abnormal tumor metabolic products via the "γδ TCR-BTN-phosphoantigen" signaling pathway; on the other hand, specifically targeting the highly expressed tumor antigen B7H3 through a chimeric antigen receptor (CAR), forming a dual-targeting effect that significantly enhances anti-tumor efficacy and safety. The drug utilizes a fully enclosed semi-automated production process, achieving a breakthrough in the scaled manufacturing of cellular drugs, drastically reducing production costs and improving treatment accessibility. Clinical trial data shows a 100% disease control rate in patients with malignant glioma, demonstrating excellent clinical therapeutic potential.

Qinghui Lianuo is an innovative biopharmaceutical company with γδ T-cell immunotherapy technology as its core competence. Relying on the world's leading γδ T-cell technology platform, the company focuses on unmet clinical needs in the fields of oncology and autoimmune diseases, and has built a multi-dimensional R&D pipeline covering allogeneic off-the-shelf cell therapy drugs and novel small-molecule agonists. Currently, three self-developed allogeneic γδ T-cell therapy products have entered the clinical research stage, showing breakthrough efficacy in the treatment of glioblastoma, B-cell malignancies, and acute myeloid leukemia. Through an innovative fully closed automated production process, the company has successfully achieved scaled production and cost control of cellular drugs. The company is also advancing the clinical application of γδ T-cell small-molecule agonist drugs, further demonstrating the extensibility and commercial value of the platform technology.