Beone Medicines’ next-generation BCL2 inhibitor sonrotoclax, branded Beqalzi, gained U.S. FDA accelerated approval for patients with relapsed or refractory mantle cell lymphoma after treatment with a BTK inhibitor. The approval makes Beqalzi the first BCL2-targeting drug indicated for MCL in the United States. Beone noted the company’s earlier China clearance for sonrotoclax and highlighted combination potential with BTK therapy Brukinsa (zanubrutinib). The accelerated approval framework points to ongoing data generation to confirm and expand benefit over time. For market participants, the addition further intensifies competition in relapsed/refractory MCL and supports continued investment in BCL2 strategy refinements and combination regimens.