BeOne Medicines Ltd. (06160): Baiyueda has been 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.

BeOne Medicines Ltd. (06160) announced on May 13, 2026 (Eastern Time) that BeiYueDa (sotocra, BEQALZI) has received accelerated approval from the Food and Drug Administration (FDA) of the United States for the treatment of relapsed or refractory (R/R) mantle cell lymphoma (MCL) in adults who have received at least two lines of systemic therapy (including Bruton's tyrosine kinase (BTK) inhibitors) in the past. Sotocra is a new generation BCL2 inhibitor with foundational potential in BCL2 targeting, designed to enhance the activity of BCL2 inhibitors by optimizing molecular potency and selectivity. Its pharmacological properties are expected to improve the effectiveness, tolerability, and convenience of treatment. Dr. Michael Wang, the lead investigator at the University of Texas MD Anderson Cancer Center's Department of Lymphoma and Myeloma, stated: "The research data supporting sotocra's approval in the United States demonstrate its significant therapeutic positioning in MCL in the context of previous BTK inhibitor therapy and suggest its potential for achieving disease control in patients with limited treatment options and poor prognosis. From a clinical perspective, this provides new reference information for physicians in the relevant treatment area and lays the groundwork for further exploration of the balance between efficacy and tolerability, as well as our clinical approach to the treatment strategy for this disease."