Zanubrutinib is the first domestically-developed anticancer drug approved in the United States, featuring superior efficacy, high safety, and a broad range of globally approved indications.
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Privacy On June 3, 2020, the National Medical Products Administration (NMPA) granted
conditional approval to zanubrutinib for the treatment of adult patients with
mantle cell lymphoma (MCL) who have received at least one prior therapy, and
adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic
lymphoma (SLL) who have received at least one prior therapy.
On June 19, 2021, the NMPA granted conditional approval to zanubrutinib for
the treatment of adult patients with Waldenström's macroglobulinemia (WM) who
have received at least one prior therapy.
On May 8, 2023, the NMPA approved zanubrutinib for the treatment of adult
patients with newly diagnosed chronic lymphocytic leukemia (CLL)/small
lymphocytic lymphoma (SLL) and adult patients with newly diagnosed Waldenström's
macroglobulinemia (WM). Meanwhile, the indications for adult patients with
previously treated CLL/SLL and WM were converted from conditional approval to
full approval.
On May 8, 2024, the NMPA granted conditional approval to zanubrutinib in
combination with obinutuzumab for the treatment of adult patients with relapsed
or refractory follicular lymphoma (FL) who have received at least two prior
lines of systemic therapy (the approval certificate was served on May 13,
2024).
On May 13, 2024, BeiGene announced that zanubrutinib (Chinese brand name: 百悦泽; international brand name: BRUKINSA), its Bruton's tyrosine kinase (···【Read More】
Update: 05 Feb,2026Source: Haiou HealthViews: 125
On May 6, 2023, BeiGene announced that the National Medical Products Administration (NMPA) of China had approved four related registration application···【Read More】
Update: 05 Feb,2026Source: Haiou HealthViews: 112
On June 22, 2021, BeiGene announced that the National Medical Products Administration (NMPA) of China had granted conditional approval to 百悦泽 (zanubru···【Read More】
Update: 05 Feb,2026Source: Haiou HealthViews: 116
On June 3, 2020, the National Medical Products Administration (NMPA) granted conditional approval for the marketing of Zanubrutinib Capsules (brand na···【Read More】
Update: 05 Feb,2026Source: Haiou HealthViews: 102
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