BeiGene announced on January 6 that its self-developed new class 1 BCL2 inhibitor, Baiyueda®, has been conditionally approved by the National Drug Administration to treat adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma who have previously received at least one system treatment including Bruton's tyrosine kinase inhibitors, and adult patients with recurrent or refractory mantle cell lymphoma who have received at least two types of systematic treatment in the past. Based on this approval, Sotocla will bring new treatment options to CLL/SLL patients who have already been treated with BTK inhibitors, making it the first and only BCL2 inhibitor in China that can be used to treat MCL. The marketing application for these two indications was previously included in the priority review process by the NMPA Drug Evaluation Center.

Zhitongcaijing · 5d ago
BeiGene announced on January 6 that its self-developed new class 1 BCL2 inhibitor, Baiyueda®, has been conditionally approved by the National Drug Administration to treat adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma who have previously received at least one system treatment including Bruton's tyrosine kinase inhibitors, and adult patients with recurrent or refractory mantle cell lymphoma who have received at least two types of systematic treatment in the past. Based on this approval, Sotocla will bring new treatment options to CLL/SLL patients who have already been treated with BTK inhibitors, making it the first and only BCL2 inhibitor in China that can be used to treat MCL. The marketing application for these two indications was previously included in the priority review process by the NMPA Drug Evaluation Center.