Ge Long Hui·2026-01-06 11:01Core Viewpoint - BeiGene (6160.HK) announced that its self-developed first-in-class BCL2 inhibitor, Baiyueda® (Sotukral tablets), has received conditional approval from the National Medical Products Administration (NMPA) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received at least one systemic treatment including a Bruton tyrosine kinase (BTK) inhibitor, as well as for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two systemic treatments including a BTK inhibitor [1] Group 1 - The approval of Sotukral provides a new treatment option for CLL/SLL patients who have previously been treated with BTK inhibitors [1] - Sotukral becomes the first and only BCL2 inhibitor approved for the treatment of MCL in China [1] - The applications for these indications were previously included in the priority review process by the NMPA's Center for Drug Evaluation (CDE) [1]