Sonrotoclax: First Approval

DeclarationsAuthorship and Conflict of interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Hannah Blair is a salaried employee of Adis International Ltd/Springer Nature and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.Additional information about this Adis Drug Review can be found here.

AbstractSonrotoclax (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.

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