BEIGENE's BCL-2 Inhibitor "Sotokela" Approved for Market Launch

Deep News

Jan 05

On January 5th, the NMPA official website indicated that BEIGENE's BCL-2 inhibitor "Sotokela" has received approval in China for two indications. It is indicated for the treatment of adult patients with previously treated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and for the treatment of adult patients with mantle cell lymphoma (MCL) who have previously received anti-CD20 therapy and BTKi therapy.

Sotokela is a potent, highly selective BCL-2 inhibitor developed by BEIGENE, designed to achieve deeper and more sustained target inhibition. According to BEIGENE, compared to venetoclax, Sotokela demonstrated higher potency (a difference greater than 10-fold) and target selectivity in both preclinical studies and tumor models, with the potential to overcome drug resistance.

At the 2025 ASH annual meeting, BEIGENE presented the latest clinical research data (BGB-11417-101/202) for Sotokela as a monotherapy and in combination therapies for B-cell malignancies. When combined with zanubrutinib in treatment-naïve CLL/SLL patients, the objective response rate (ORR) reached 100%, with an undetectable minimal residual disease rate (uMRD4) of 91% at 48 weeks. The combination with obinutuzumab achieved an ORR of 93%, with a median time to achieving uMRD of 2.3 months.

As a monotherapy in relapsed/refractory (R/R) CLL/SLL patients, Sotokela achieved an ORR of 76% and a best hematologic uMRD rate of 49.0%.

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