Baiji State BRUKINSA ™ (Zebutini) gets accelerated FDA approval

Today, Baiji Shenzhou announced that the BRUKINSA ™ (BRUKINSA ™, General Name: Zebutini) has been approved by the U.SFoodDrug(http://Regulatory Authority (
FDA(http://) to accelerate approval for the treatment of adult set of cell lymphoma (MCL) patients who have received at least one treatment in the pastAbout BRUKINSA
BRUKINSA is the firstproduct(http://developed and approved for marketing by Baiji Shenzhou, a major milestone in the development of's(http:// and brings us one step closer to the goal of bringing a transformative treatment to cancer patients worldwide 　　BRUKINSA's FDA approval is based on validity data for two clinically trial (http:// , which show that BRUKINSA produced a total remission rate of up to 84% (total remission and partial remission combined; ORR) in patients participating in both clinical trials 　　In Zebutinib's multi-center Phase 2 clinical trial BGB-3111-206 (clinicaltrials.gov registration number: NCT03206970) for the treatment of recurrent/difficult to treat (R/R) MCL patients, orRR was 84% (95% confidence interval: 74%, 91%), including 59% of the total remission (FDG-PET scans in this phase) and part of the mitigation test 　　The median duration of continuous mitigation (DOR) in this trial was 19.5 months (95% CI: 16.6, NE) and the median follow-up time was 18.4 months In Phase 1/2 clinical trials in the world BGB-3111-AU-003 (clinicaltrials.gov registration number: NCT02343120), ORR was 84% (95% confidence interval: 67%, 95%), including 22% of the total mitigation (FDG-PET scans are not required in this trial) and 62% partial remission 　　The median DOR for this trial was 18.5 months (95% CI: 12.6, NE) and the median follow-up time was 18.8 months 　　In terms of safety
the most common adverse reactions (more than 10%) of BRUKINSA were reduced neutrophil counts, reduced platelet counts, upper respiratory tract infections, reduced white blood cell counts, bloodcell reduction, rash, bruising, diarrhea, cough, musculoskeletal pain, pneumonia, urinary tract infections, hematuria, fatigue, constipation, and bleeding 　　The most common severe adverse reactions were pneumonia (11%) and bleeding (5%)