FDA grants Bacchishents BTK inhibitorzanubrutinib breakthrough therapy designation

lymphoma is a group of malignant tumors with multiple subtypes that originate in B, T or NK cellsSet cell lymphoma (MCL) is usually an invasive non-Hodgkin's lymphoma (NHL) that originates from B cells in the "set area"recently, Baiji Shenzhou (NASDAQ: BGNE; HKEx code: 06160) announced that the U.SFoodDrug(http://Regulatory Authority (
FDA(http://) awarded its breakthrough treatment of the Bruton's tyrosine kinase (BTK) inhibitor, the Breakthrough Disease, for the treatment of at least one previously treated adult patient with lymphoma (MCL)ZanubrutinibZanubrutinib, a small molecule inhibitor of Bruton's tyrosine kinase (BTK), is currently being conducted globally in a wide range of critical clinicaltrials(http://program for the treatment of multiple lymphomas as a single drug and in combination with other therapiesBroadwide clinical studies of zanubrutinib include a completed group of patients with Fahrenheit hyperglobulinemia (WM) patients compared to ibitinib in the global Phase 3 clinical study:a global study of patients with initial lymphocytic leukemia (CLL)/small lymphocytic lymphocyte (SLL) Phase 3 Clinical Research; A Global Critical Phase 2 Clinical Study on Recurrent/Difficult Treatment (R/R) Follinostic Lymphoma in combination with GAZYVA ® (Obituzumab); a Global Phase 3 Clinical Study on Ibbutini in R/R/CLL Patients; 　　A global Phase 1 clinical study in China, Baiji Shenzhou has completed two key Phase 2 clinical trials of zanubrutinib for the treatment of MCL patients and CLL/SLL patients, respectively, and zanubinib for the treatment of Patients in WM, and the entry of key Phase 2 clinical trial patients for the treatment of WM patients the U.S Food and Drug Administration (FDA) has granted zanubrutinib fast-track eligibility for the treatment of WM patients and breakthrough therapeutic designations for adult MCL patients who have previously received at least one treatment the National Drug Administration (NMPA) Drug Review Centre (CDE) is reviewing zanubrutinib's new drug (http:// listing application (NDA) for the treatment of R/R MCL and R/R CLL/SLL, both of which are included in the priority review