BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced the China National Medical Products Administration (NMPA) approved four applications for BRUKINSA (zanubrutinib), the company’s Bruton’s tyrosine kinase inhibitor (BTKi), including two Supplemental New Drug Applications for treatment-naïve adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and Waldenström's macroglobulinemia (WM), and two Supplemental Applications for conversions from conditional approval to regular approval.

“These approvals further support BRUKINSA as the BTKi of choice in China for the treatment of B-cell malignancies such as CLL and WM”

“These approvals further support BRUKINSA as the BTKi of choice in China for the treatment of B-cell malignancies such as CLL and WM,” said Lai Wang, Ph.D., Global Head of R&D at BeiGene. “We look forward to bringing people living with CLL and WM a new first-line treatment option as we work to support the Healthy China initiative and reduce global health inequity.”

BRUKINSA previously received conditional approvals from NMPA for the treatment of adult patients with CLL/SLL and mantle cell lymphoma (MCL) who have received at least one prior therapy (R/R CLL/SLL and R/R MCL) in June 2020, and conditional approval for the treatment of adult patients with WM who have received at least one prior therapy (R/R WM) in June 2021. NMPA converted these conditional approvals to regular approvals for R/R CLL/SLL and R/R WM in April 2023.

"CLL/SLL and WM patients are predominantly populated in the elderly, and there are increasing needs for improved efficacy and safety in CLL/SLL and WM treatments," said Professor Ma Jun, Director of the Harbin Institute of Hematology & Oncology, Chief Supervisor of Supervisory Committee at the Chinese Society of Clinical Oncology. “BRUKINSA has been recommended as the preferred regimen of multiple subtypes of lymphoma in both national and international guidelinesⁱ,ⁱⁱ,ⁱⁱⁱ,^iv,^v. With these important approvals, BRUKINSA now becomes the only approved new-generation BTK inhibitor in China for the first-line treatment of adult CLL/SLL and WM patients, bringing healthcare providers in China with a new standard of care for their patients."

The new approvals of BRUKINSA for CLL/SLL are supported by data from SEQUOIA (NCT03336333), in patients with previously untreated CLL/SLL. The new approvals of BRUKINSA for WM are based on data from ASPEN (NCT03053440), the first and only global Phase 3 head-to-head clinical trial of BTK inhibitors in WM.