On June 3, 2020, the National Medical Products Administration (NMPA) granted
conditional approval for the marketing of Zanubrutinib Capsules (brand name:
BRUKINSA), a Class 1 innovative drug developed by BeiGene (Suzhou) Biotech Co.,
Ltd., through its priority review and approval process. The drug is indicated
for adult patients with mantle cell lymphoma (MCL) who have received at least
one prior line of therapy, and adult patients with chronic lymphocytic leukemia
(CLL)/small lymphocytic lymphoma (SLL) who have received at least one prior line
of therapy.
Zanubrutinib is a selective inhibitor of Bruton's tyrosine kinase (BTK). Developed independently in China with proprietary intellectual property rights, Zanubrutinib Capsules will offer additional therapeutic alternatives for patients suffering from adult mantle cell lymphoma, adult chronic lymphocytic leukemia and small lymphocytic lymphoma.
The NMPA requires the marketing authorization holder (MAH) of this product to complete the confirmatory clinical trials as scheduled after the drug is launched on the market.
