Oncology company BeOne Medicines Ltd (Nasdaq: ONC) (HKEX: 06160) (SSE: 688235) announced on Wednesday that the U.S. Food and Drug Administration has granted Priority Review to the company's New Drug Application for sonrotoclax, a next-generation BCL2 inhibitor for adult patients with relapsed or refractory mantle cell lymphoma following treatment with a Bruton's tyrosine kinase inhibitor.

Priority Review follows earlier Breakthrough Therapy Designation and is backed by results from the global Phase 1/2 study BGB-11417-201, which enrolled 125 patients. Sonrotoclax met its primary endpoint of overall response rate, with additional signals of efficacy across complete response rate, duration of response and progression-free survival. Treatment was reported as well tolerated with manageable risks.

Full data will be presented at the American Society of Hematology Annual Meeting in Orlando from 6-9 December 2025. BeOne Medicines will also participate in the FDA's Project Orbis to support concurrent international review and plans further regulatory submissions, including to the European Medicines Agency.

Sonrotoclax applications for relapsed or refractory mantle cell lymphoma and relapsed or refractory chronic lymphocytic leukemia / small lymphocytic lymphoma are under review by the Center for Drug Evaluation of the China National Medical Products Administration for potential accelerated approval.