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Text|Pharmaceutical Mission Hills
According to the official website of the National Food and Drug Administration (NMPA) of China, the listing application for the CD38 monoclonal antibody daratumumab injection (subcutaneous injection) of Johnson & Johnson's Janssen company has been updated to: under review, which means The drug is expected to be approved in China in the near future
Image source: NMPA official website
Public information shows that daratumomab is the first fully human monoclonal antibody targeting CD38 approved globally and in China.
Previously, daratumomab subcutaneous injection has been approved by the FDA in the United States for the treatment of multiple myeloma, light chain (AL) amyloidosis and other indications
In November 2020, Janssen submitted a listing application for daratumomab injection (subcutaneous injection) in China
Image source: CDE official website
In China, primary light chain amyloidosis has been included in the "First List of Rare Diseases
Studies have shown that daratumomab can specifically recognize CD38 that is highly expressed on malignant plasma cells of multiple myeloma with high affinity, and then induce tumor cell death through a variety of immune-mediated mechanisms
According to data from a phase 3 study called ANDROMEDA, the study evaluated daratumomab injection (subcutaneous injection) in combination with bortezomib, cyclophosphamide and dexamethasone (VCd regimen), and VCd regimen alone Compared with the efficacy and safety
Reference materials:
[1] Drug registration progress query.
[2] US Food and Drug Administration Approves DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj), a New Subcutaneous Formulation of Daratumumab in the Treatment of Patients with Multiple Myeloma.
[3] Genmab Announces Positive Topline Results in Phase III ANDROMEDA Study of Daratumumab in Light-chain (AL) Amyloidosis.
[4] DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis.
