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Mabwell Secures NMPA Clearance for First-in-Class Leukemia Antibody

China's National Medical Products Administration has authorized clinical trials for 6MW5311, a bispecific antibody designed to combat hematologic malignancies. Developed by Shanghai-based Mabwell, the candidate is the first LILRB4/CD3-targeting T Cell Engager globally to receive regulatory approval for human testing, marking a potential shift in treating acute myeloid leukemia.

Mabwell Secures NMPA Clearance for First-in-Class Leukemia Antibody
Photo: Bio & News

The drug utilizes a specialized "2+1" asymmetric molecular structure to bridge tumor cells and T cells, triggering an immune response only upon contact with malignant cells. This design, which employs steric hindrance, aims to minimize off-target activation, theoretically improving patient safety compared to traditional chemotherapy or stem cell transplants. Preclinical data shows the molecule achieves complete tumor clearance in high-expression models, providing a foundation for upcoming human trials.

While T Cell Engager technology has proven effective in treating various lymphomas, the therapeutic landscape for acute myeloid leukemia, chronic myelomonocytic leukemia, and multiple myeloma remains heavily dependent on conventional methods. With global diagnoses for acute myeloid leukemia projected to climb to 221,400 cases by 2035, the industry is under pressure to find alternatives to standard marrow-based treatments. Mabwell, which already holds FDA clearance for the same candidate, plans to leverage this dual regulatory momentum to advance 6MW5311 through its clinical pipeline.

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