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BeiGene (BGNE) Announces Supplemental NDA for BRUKINSA in Waldenstrom’s Macroglobulinemia Accepted in China

Go back to BeiGene (BGNE) Announces Supplemental NDA for BRUKINSA in Waldenstrom’s Macroglobulinemia Accepted in China

BeiGene Announces Acceptance of a Supplemental New Drug Application in China for BRUKINSA (zanubrutinib) in Waldenström’s Macroglobulinemia

January 20, 2022 5:00 AM EST

BRUKINSA received the China NMPA approval for the treatment of patients with relapsed or refractory Waldenströms macroglobulinemia (WM) in June 2021

The submission, supported by the ASPEN trial results, could potentially expand BRUKINSA to front-line care of WM

CAMBRIDGE, Mass., & BEIJING--(BUSINESS WIRE)-- BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced that the Center for Drug Evaluation (CDE) of the China National Medical... More