By Fineline Cube 
Beijing Unicet Biotechnology Co., Ltd. announced that its pioneering QH104A—the world’s first B7H3‑targeted, off‑the‑shelf allogeneic CAR‑γδ T‑cell therapy—has obtained implicit approval for clinical trials from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). The therapy is slated to treat recurrent or progressive malignant tumors of the central nervous system (CNS).
Why QH104A Is a Breakthrough
- Dual‑Market Regulatory Milestone: QH104A is the first allogeneic cell therapy for solid tumors to secure simultaneous regulatory submissions and approvals in both China and the United States.
- Targeted Antigen: It uniquely targets B7H3, a cell surface protein overexpressed in a wide range of CNS malignancies, offering a precision‑medicine approach rarely seen in solid‑tumor immunotherapy.
- CAR‑γδ Synergy: By combining the innate antigen‑recognition of γδ T cells with the precision of CAR technology, the therapy delivers deeper, more sustained tumor‑cell killing while preserving off‑target safety.
Clinical and Commercial Implications
- Off‑the‑Shelf Advantage: The “off‑the‑shelf” design eliminates the need for patient‑specific manufacturing, reducing turnaround time and cost—critical factors for treating aggressive CNS tumors.
- Global Positioning: With approvals in both major regulatory jurisdictions, QH104A is poised to become a first‑in‑class option for clinicians worldwide seeking novel solutions for hard‑to‑treat CNS malignancies.-Fineline Info & Tech