Zebutinib capsules are indicated for the treatment of: Adult mantle cell lymphoma (MCL) patients who have received at least one previous treatment. Adult chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) patients who have received at least one previous treatment. The above indications were conditionally approved based on the objective response rate results of a single-arm clinical trial. The full approval of this product will depend on the results of the ongoing confirmatory randomized controlled clinical trials.
Zebutinib is a selective inhibitor of Bruton’s tyrosine kinase (BTK), which inhibits BTK activity by covalently binding to the cysteine at site 481 of the BTK protein, thereby inhibiting its tyrosine phosphorylation at site 223. It inhibits the growth of Rec-1 mantle cell lymphoma cells and TMD-8 diffuse large B-lymphoma cells in a dose-dependent manner.
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