On January 24, Sanofi's anti-CD38 monoclonal antibody Isatuximab Injection (trade name: Seco-Yi) was approved by the National Medical Products Administration (NMPA) for use in combination with bortezomib, lenalidomide and dexamethasone (VRd) to treat adult patients with newly diagnosed multiple myeloma (NDMM) who are not suitable for autologous stem cell transplantation (ASCT). This product is the world's first anti-CD38 monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) to be combined with standard treatment VRd to treat NDMM patients who are not suitable for ASCT. It has now become the first and currently the only anti-CD38 monoclonal antibody approved for this indication in China. The second-line indication of this product was first approved for marketing in China in early January 2025.
Sanofi's anti-CD38 monoclonal antibody is approved for first-line indication in China
2025-01-24 21:57:20
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