BeiGene Announces Brazil Approvals for BRUKINSA® As a Treatment for Rare Blood Cancers

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CAMBRIDGE, Mass., & BASEL, Switzerland & BEIJING– BeiGene, (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology, today announced BRUKINSA (zanubrutinib) has been approved in Brazil for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) and adult patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. BRUKINSA was previously approved as a treatment in Brazil for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. BeiGene is focused on developing innovative and affordable oncology medicines to improve treatment outcomes and access for patients worldwide.

“We have carried out an expansive and global clinical development program for our innovative BTK inhibitor, BRUKINSA, which has led to approval for the treatment of WM, MZL, and MCL in Brazil. These approvals demonstrate our commitment to accelerate development and broaden access to innovative medicines around the globe,” said Alex Carvalho, Country General Manager, Brazil, at BeiGene. “I’m proud to bring this potentially best-in-class medicine to Brazil and look forward to working with our partner, Adium on commercialization activities.”