Sanofi's CD38 Monoclonal Antibody Isatuximab Receives First-in-China Approval for Newly Diagnosed Multiple Myeloma
Sanofi
Pharmaceutical R&D Developer
January 24,SanofiAnnounced itsCD38 Monoclonal Antibody "Isatuximab"New indications approved for marketing in China,Used forIn combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of newly diagnosed multiple myeloma (NDMM) in patients who are not eligible for autologous stem cell transplantation (ASCT).Adult patients.
The press release pointed out,IsatuximabYesThe World's FirstReceived FDA ApprovalApproved for use in combination with standard treatment VRd for patients ineligible for ASCTThe anti-CD38 monoclonal antibody for NDMM patients has now also becomeMiddleChina's FirstAnd currently the only approved anti-CD38 monoclonal antibody for this indication.Anti.
Isatuximab（Isatuximab）Is a monoclonal antibody drug that Sanofi introduced from ImmunoGen. The collaboration between the two parties was reached as early as 2017. In March 2020, the drugFirst FDA Approval for U.S. Market, with pomalidomide and dexamethasone（pom-dex）Combination therapy for patients who have received at least two prior treatments(Including lenalidomide and proteasome inhibitors)Relapsed and Refractory Multiple Myeloma（R/R MM）Adult patients, trade nameSarclisa®；In May and June of the same year, it was approved in the EU and Japan respectively; January 2025First Approval for Marketing in China。
Screenshot source: Insight database
Screenshot source: Insight database
MM drugs represented by CD38 have broad and deep market potential.In this field,Johnson & Johnson's blockbuster drug Daratumumab（Darzalex）Since its first approval for marketing in 2015, nearly ten years have passed, and it still maintains a strong year-on-year growth rate of 22.15%. The sales revenue for the year 2023 has reached 9.744 billion US dollars, and it is about to enter 2024.The Billion-Dollar Club。
AndSanofi's IsatuximabAs a newcomer, with the continuous expansion of indications, its future potential is equally impressive.Insight database shows that its global sales in 2023 were US$412 million, increasing by 33.14% year-on-year.
