BeiGene (688235.SH): Baiyueda® received accelerated approval from the US FDA for the treatment of relapsed/refractory mantle cell lymphoma

Zhitong Finance App News, BeiGene (688235.SH) announced that the company's product Baiyueda® (BEQALZI™) has obtained accelerated approval from the US Food and Drug Administration (FDA) to treat adult patients with recurrent or refractory (R/R) mantle cell lymphoma (MCL) who have previously received at least two line system treatments (including Bruton's tyrosine kinase (BTK) inhibitors).

The accelerated approval of Baiyue® is supported by efficacy and safety data from the BGB-11417-201 (NCT05471843) Phase 1/2 study. The results of the study were presented at the 67th Annual Meeting of the American Society of Hematology (ASH).

Baiyueda® (Sotocla) is a new generation B-cell lymphoma 2 (BCL2) inhibitor with the best potential in its class. It has unique pharmacokinetic and pharmacodynamic characteristics. Preclinical and clinical studies of early drug development have shown that sotocla is a BCL2 inhibitor with high efficacy and high specificity potential, and shows pharmacokinetic characteristics with a short half-life and no observed drug accumulation. Sotocla has shown good clinical activity in various B-cell malignancies, including chronic lymphocytic leukemia (CLL), and is being developed as a monotherapy and in combination with other drugs (including zebutinib).