China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced that it has received marketing approval in Brazil for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The in-house developed drug is now approved for the treatment of Waldenström’s macroglobulinemia (WM) and relapsed/refractory (r/r) marginal zone lymphoma (MZL) in patients who have previously received at least one anti-CD20 therapy. This approval expands the drug’s indications in Brazil, where it was previously approved for the treatment of mantle cell lymphoma (MCL).
Global Regulatory Progress
Brukinsa is currently awaiting regulatory decisions for over 40 filings around the globe. The drug has already received approvals in more than 55 countries and regions, including the United States, China, the European Union, Switzerland, Great Britain, Canada, Australia, and other international markets. In 2020, Brukinsa was added to China’s National Reimbursement Drug List (NRDL), further enhancing its accessibility to patients in need.-Fineline Info & Tech
