Sonrotoclax: First Approval.

Sonrotoclax (Baiyueda®), a small-molecule B-cell lymphoma-2 (BCL-2) inhibitor, is being developed by BeOne Medicines for the treatment of various B-cell malignancies. On 6 January 2026, sonrotoclax received conditional approval in China for adult patients with chronic lymphocytic leukaemia (CLL)/small lymphocytic leukaemia (SLL) who have previously received at least one systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor, and adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received at least two systemic therapies, including a BTK inhibitor. This article summarizes the milestones in the development of sonrotoclax leading to this first approval for the second-line treatment of relapsed/refractory CLL/SLL and MCL.