Sonrotoclax wins first-in-world approval in China for R/R MCL and CLL/SLL, with FDA Priority Review and multiple expedited designations supporting global development.
Written By: Samiksha Jadhav BPharm
Reviewed By: Pharmacally Editorial Team
BeOne Medicines has achieved a major milestone in hematologic oncology with the first-in-world approval of sonrotoclax in China for the treatment of patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) and R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Sonrotoclax is a next-generation BCL2 inhibitor designed to address key limitations of earlier therapies in B-cell malignancies.
The approval by China’s regulatory authorities positions sonrotoclax as a breakthrough targeted therapy, particularly for high-risk patient populations where disease progression and resistance to prior treatments remain common and outcomes are often poor. This landmark decision underscores the growing role of innovative, China-led drug development in advancing global hematologic cancer care.
A Next-Generation Approach to BCL2 Inhibition
BCL2 is a key anti-apoptotic protein that allows malignant B cells to survive despite genomic instability and therapeutic pressure. While earlier BCL2 inhibitors validated this target, limitations related to resistance, tolerability, and durability of response have driven the search for improved molecules.
Sonrotoclax was designed to deliver potent and selective BCL2 inhibition with optimized pharmacologic properties. By directly restoring programmed cell death in cancerous B cells, the drug addresses one of the central survival mechanisms in MCL and CLL/SLL. Importantly, its molecular profile supports sustained target engagement, which may translate into deeper and more durable remissions.
Clinical Evidence Supporting Approval
The approval was based on parallel submissions from two clinical studies, with key data presented at the 67th Annual Meeting & Exposition of the American Society of Hematology (ASH) in Orlando, Florida. Together, these studies demonstrated robust clinical activity of sonrotoclax monotherapy in heavily pretreated patients with relapsed or refractory B-cell malignancies.
In a Phase 1/2 single-arm study involving patients with R/R mantle cell lymphoma treated with sonrotoclax 320 mg (n=103), the overall response rate (ORR) assessed by an independent review committee (IRC) was 52.4%. This population included patients with prior exposure to BTK inhibitors, a group with historically limited treatment options and poor outcomes.
In a separate Phase 2 open-label study of patients with R/R CLL/SLL treated with sonrotoclax (n=100), the IRC-assessed ORR reached 77%, highlighting substantial antitumor activity in this relapsed setting.
Across both studies, sonrotoclax monotherapy was generally well tolerated, with adverse events that were manageable and consistent with the known safety profile of BCL2 inhibition. The combination of meaningful response rates and a favourable tolerability profile supported regulatory confidence in approving sonrotoclax for both R/R MCL and R/R CLL/SLL.
Global Expansion and Regulatory Acceleration
The approval of sonrotoclax in China forms part of a broader global strategy to expand patient access to the therapy. In parallel, data from the Phase 1/2 study evaluating sonrotoclax monotherapy in patients with relapsed or refractory mantle cell lymphoma are currently under Priority Review by the U.S. Food and Drug Administration for potential accelerated approval. The FDA has also granted Breakthrough Therapy Designation for sonrotoclax in adult patients with R/R MCL, underscoring its potential to offer meaningful clinical benefit over existing treatments. In addition, sonrotoclax has received Fast Track Designation for mantle cell lymphoma and Waldenström macroglobulinemia, along with Orphan Drug Designation for multiple hematologic malignancies, including MCL, Waldenström macroglobulinemia, multiple myeloma, acute myeloid leukemia, and myelodysplastic syndrome.
About MLL/CLL
Mantle cell lymphoma and chronic lymphocytic leukemia are B-cell malignancies driven by abnormal survival and accumulation of malignant lymphocytes. Mantle cell lymphoma typically follows an aggressive course with frequent relapse after initial therapy, while chronic lymphocytic leukemia shows a more variable disease trajectory but remains incurable for many patients. In both diseases, dysregulation of apoptosis, often mediated through BCL2-dependent pathways, plays a central role in disease progression and treatment resistance, highlighting the ongoing need for more effective targeted therapies in relapsed or refractory settings.
References
BeOne Medicines’ Novel BCL2 Inhibitor, Sonrotoclax, Achieves First-in-World Approval in R/R MCL and R/R CLL/SLL, 06 January 2026, https://ir.beonemedicines.com/news/beone-medicines-novel-bcl2-inhibitor-sonrotoclax-achieves-first-in-world-approval-in-rr-mcl-and-rr-cllsll/562da165-f6a9-48d0-a357-aca27ac112ca
Sonrotoclax Data at ASH 2025 Confirm Foundational Potential Across B-cell Malignancies, 07 December 2025, https://ir.beonemedicines.com/news/sonrotoclax-data-at-ash-2025-confirm-foundational-potential-across-b-cell-malignancies/4c69168c-15f1-4af8-98f3-38d14b8d32cd
Study of BGB-11417 Monotherapy in Participants with Relapsed or Refractory Mantle Cell Lymphoma, ClinicalTrials.gov ID NCT05471843, https://clinicaltrials.gov/study/NCT05471843