BEIGENE (06160) announced that on August 29, 2025, the company reported positive results from a Phase 1/2 clinical study (BGB-11417-201) of sonrotoclax, a next-generation investigational BCL2 inhibitor with potential best-in-class profile, for treating adult patients with mantle cell lymphoma (MCL) who have previously received Bruton's tyrosine kinase (BTK) inhibitor and anti-CD20 therapy. The company plans to present complete data at upcoming academic conferences.

"For MCL patients, the disease remains aggressive with limited treatment options and unsatisfactory efficacy. The clinical study results of sonrotoclax demonstrate its potential to bring significant and durable remissions to MCL patients. If approved, it would provide the first BCL2 inhibitor treatment option for this patient population," said Dr. Wang Lai, Global Head of Research and Development at BEIGENE. "Over the past five years, we have made significant progress in treating B-cell malignancies including chronic lymphocytic leukemia (CLL). BEIGENE takes pride in playing an important role in this therapeutic revolution through our core BTK inhibitor products. The positive results achieved in the sonrotoclax study will add a new chapter to our portfolio in this disease area."

The BGB-11417-201 (NCT05471843) study is a global, multicenter, single-arm, open-label Phase 1/2 clinical trial that has enrolled 125 adult MCL patients who previously received BTK inhibitor and anti-CD20 therapy. In Part 1 of the study, 22 patients received 160mg or 320mg of sonrotoclax daily to evaluate safety and tolerability and determine the recommended dose for Part 2. In Part 2, 103 patients were enrolled to receive the recommended daily dose of sonrotoclax (320mg) to evaluate efficacy and safety.

The study met its primary endpoint of overall response rate (ORR) as assessed by an independent review committee (IRC), demonstrating that sonrotoclax achieved clinically meaningful responses in treating this patient population. Multiple secondary efficacy endpoints, including complete response rate (CRR), duration of response (DOR), and progression-free survival (PFS), all showed positive results. The study demonstrated a generally well-tolerated safety profile with manageable toxicity.

This represents another important milestone in BEIGENE's hematologic oncology product portfolio. Currently, BEIGENE has positioned three major products in the hematologic oncology field, aimed at meeting the evolving clinical medical needs of various B-cell malignancy patients.

BEIGENE is submitting data to the U.S. Food and Drug Administration (FDA) and regulatory agencies worldwide to seek potential approval for sonrotoclax in the MCL indication. Currently, new drug applications for sonrotoclax for treating MCL and CLL/SLL patients have been accepted by China's Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) and included in the priority review and approval process, currently under review.

The Phase 3 confirmatory CELESTIAL-RRMCL study (BGB-11417-302; NCT06742996) is ongoing, with the first patient enrolled earlier this year. Previously, the FDA has granted sonrotoclax "Orphan Drug" designation for treating MCL patients.