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On June 7, the official website of the State Food and Drug Administration showed that BeiGene Zebutinib Capsule's new adaptation marketing application (acceptance number CXHS2000037) was in the "under review" stage and will be approved by the NMPA in the near future
.
For the treatment of adults with Waldenstrom's macroglobulinemia (WM), this will be the third indication for the product to be approved
A single-arm, open, multi-center, pivotal Phase II clinical trial code-named BGB-3111-210 evaluated the efficacy of Zebutinib in the treatment of R/R WM Chinese patients
.
A total of 44 patients were enrolled in the trial