Beone Medicines’ next-generation BCL2 inhibitor sonrotoclax (Beqalzi) won U.S. FDA accelerated approval for patients with relapsed or refractory mantle cell lymphoma after treatment with a BTK inhibitor. The approval marks the first BCL2-targeting therapy in the US specifically indicated for mantle cell lymphoma in this post-BTK setting, according to the company. Beone had already received its first regulatory clearance in China for the program. The company highlighted potential combination opportunity with zanubrutinib (Brukinsa), where sequencing or pairing with BTK inhibition could become an important strategy if durability and response depth translate across broader patient cohorts.