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Following the recent approvals in the United States, China, Brazil and Canada, Baiyueze ® was approved in the European Union
Based on this approval Perrier Chak & reg; for Bi Yibu imatinib 3 Qi ASPEN head-to-head clinical trials
Beijing, China, Basel, Switzerland and Cambridge, Massachusetts, November 24, 2021/PRNewswire/ - BeiGene (Nasdaq: BGNE; Hong Kong Stock Exchange: 06160) announced today that the European Commission ( EC) Approval of Baiyueze ® (Zebutinib) for the treatment of adult patients with Waldenstrom's macroglobulinemia (WM) who have received at least one treatment in the past, or as a first-line treatment option for WM patients who are not suitable for chemotherapy and immunotherapy
"Although BTK inhibitors have become a relatively mature therapy for WM , the approval of Baiyueze ® still provides an important new treatment option for WM patients, which is expected to improve the treatment outcome of patients
Following the positive opinion of the European Medicines Agency (EMA) Committee on Medicines for Human Use (CHMP) in September, Baiyueze ® was approved by the European Commission this time based on the results of the ASPEN trial
Dr.
Gerwin Winter, senior vice president of BeiGene and head of European commercialization, said: “We have established a strong team in Europe and are committed to delivering Baiyueze ® to WM patients in need as soon as possible