Chinese biopharma BeiGene has announced the acceptance by the China National Medical Products Administration (NMPA) of a new drug application (NDA) for zanubrutinib, an investigational Bruton's tyrosine kinase inhibitor, for relapsed/refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma.
Zanubrutinib was discovered in BeiGene’s research facilities in Beijing, and is being developed globally by the company as a monotherapy and in combination with other therapies to treat various hematologic malignancies.
In August, the NMPA accepted BeiGene’s first NDA for zanubrutinib for the treatment of patients with R/R mantle cell lymphoma.
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