The world's first monoclonal antibody for the treatment of multiple myeloma CD38 has been approved for marketing in China

Today (July 5), the State Food and Drug Administration (SFDA) announced that the State Food and Drug Administration (SFDA) has recently approved the daratumumab injection conditionally Application for import registration, for single drug treatment of relapsed and refractory multiple myeloma in adult patients, including patients who have previously received a proteasome inhibitor and an immunomodulator and have developed disease at the last treatment Multiple myeloma (mm) is a malignant tumor with abnormal plasma cell proliferation It is a kind of incurable blood malignant tumor Its pathological feature is that the abnormal proliferation of effector B cells in bone marrow leads to canceration, which gradually excludes normal blood cells, resulting in the decrease of blood cell count, bone destruction and kidney damage In China, the incidence of multiple myeloma is about 1/10 million ~2/10, which has exceeded the incidence rate of acute leukemia, ranking second in the incidence rate of hematological malignancies Developed by Johnson & Johnson, darzalex is a humanized and anti-CD38 monoclonal antibody IgG1 monoclonal antibody, combined with CD38 expressed in tumor cells, induces apoptosis of tumor cells through complement dependent cytotoxicity (CDC), antibody dependent cell-mediated cytotoxicity (ADCC), antibody dependent cell phagocytosis (ADCP), FC γ receptor and other immune related mechanisms Daretosuzumab was approved by FDA in November 2015 It is the first monoclonal antibody of CD38 monoclonal antibody approved for marketing in the world Before that, the State Food and Drug Administration approved the application of Shanghai Drug Administration and approved the import of daretosuzumab for a patient with advanced myeloma To this end, the Shanghai drug regulatory bureau said that such a special task is the first time in Shanghai The approval of this drug in China will be another important development progress of dalmatizumab, which will also bring more choices to patients with multiple myeloma in China.