The State Food and Drug Administration approved the marketing of Zebutini capsules

    Issued on June 3, 2020, the state drug administration through the examination and approval procedures for priority review conditional approval paekche China (suzhou) biological technology co., LTD. 1 class innovation medicine for his jersey cloth capsule (trade name: best yue ze), used to always get at least one kind of treatment of adult cell lymphoma (MCL) patients, and always get at least one kind of treatment of adult chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SSL) patients.

    Zebutinib is a selective inhibitor of Bruton's tyrosine kinase (BTK). Zebutinib capsule is an innovative drug with independent intellectual property rights and developed independently in China. The marketing of this product will provide more drug choices for adult sleeve cell lymphoma and adult chronic lymphocytic leukemia/small lymphocytic lymphoma.

    Sfda requires the holder of a drug marketing license to continue to complete the confirmatory clinical study as scheduled after the product is marketed.

http://www.nmpa.gov.cn/WS04/CL2056/377969.html