Benzinga | Jun 18, 2021 04:31PM EDT

BeiGene Announces China NMPA Approval of BRUKINSA for the Treatment of Patients with Relapsed or Refractory Waldenstrm's Macroglobulinemia

BeiGene, Ltd. (NASDAQ:BGNE, HKEX: 06160))))), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that BRUKINSA(r) (zanubrutinib) has received conditional approval from the China National Medical Products Administration (NMPA) for the treatment of adult patients with Waldenstr?m's macroglobulinemia (WM) who have received at least one prior therapy. The supplemental new drug application was previously granted priority review by the Center for Drug Evaluation (CDE) of the NMPA in October 2020.

"With NMPA approval for BRUKINSA, our next generation BTK inhibitor, we are proud to be able to offer patients, their families, and physicians a new option for treating WM, an incurable disease that can cause significant morbidities," said Xiaobin Wu, Ph.D., General Manager of China and President of BeiGene. "This marks BRUKINSA's third approval for the treatment of B-cell malignancies in China, and we believe it may serve an important role in addressing unmet needs for patients with blood cancers around the world."