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On July 5, the State Drug Administration (FDA) conditionally approved the import registration application for Daratumumab Injection for single-drug treatment of adult patients with recurrent and refractory multiple myeloma, including patients who have previously received an protease inhibitor and an immunomodulator and developed the disease during the last treatment, according to the official website of the State Drug Administration.
the Official Website of the National Drug Administration ( I)
Dareto Umonoista is a humanized, anti-CD38 IgG1 monoclonal antibody, combined with tumor cell expression CD38, through complement-dependent cytotoxic action (CDC), antibody-dependent cell-mediated cytotoxic action (ADCC) and antibody-dependent cell phagocytosis (ADCP), and fc-based immune receptors. The listing of daretouu monobifying injections will provide new treatments for patients with recurrent and refractive multiple myeloma.
multiple myeloma is a type of hematologic malignant tumor, the incidence rate of the hematologic system malignant tumor is the second, and the trend is increasing year by year.
it is understood that daretouzumab is manufactured by Johnson and Johnson and Johnson in the United States and was first listed in November 2015 with FDA approval for the treatment of patients with multiple myeloma. Darzalex is the first monoclonal antibody approved for the treatment of multiple myeloma.
According to media reports, in December 2018, the Shanghai Drug Administration received an application for a one-time import of Darretou U-Sema for patients with advanced tumors(R) affiliated with Shanghai Jiaotong University Medical School, and the haematology department of the hospital proposed to temporarily import Daratu IIIIIIab for patients with multiple myeloma to treat late-stage refractory bone marrowoma. In February 2019, the State Drug Administration approved the application of the Shanghai Drug Administration and agreed to use it.
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