BeiGene (06160.HK): Brukinsa is approved by the US FDA to become the first and currently the only BCL2 inhibitor for the treatment of relapsed/refractory mantle cell lymphoma in the United States.

The Zhitong Finance APP learned that BeiGene (06160.HK) announced on May 13, 2026 (Eastern Time) that its product BeiYueda (Sutokra, BEQALZI) had received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory (R/R) mantle cell lymphoma (MCL) in adult patients who have received at least two prior lines of systemic therapy (including Bruton's tyrosine kinase (BTK) inhibitors). Sutokra is a new generation BCL2 inhibitor with foundational potential in BCL2-targeted development, designed to enhance the effects of BCL2 inhibition by optimizing molecular potency and selectivity, with the potential to improve the effectiveness, tolerability, and convenience of treatment.