French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Friday that it has received approval from China's National Medical Products Administration (NMPA) for Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed multiple myeloma (NDMM) patients ineligible for autologous stem cell transplant.

The decision was based on positive results from the IMROZ phase 3 study, which demonstrated significant improvement in progression-free survival compared to VRd alone.

This marks the second NMPA approval for Sarclisa in three weeks, following its authorization on 13 January 2025 for use with pomalidomide and dexamethasone (Pd) in relapsed or refractory multiple myeloma (R/R MM) patients who have received at least one prior therapy. In the Asia-Pacific region, Japan is currently reviewing a regulatory submission for Sarclisa in NDMM patients not eligible for haematopoietic stem cell transplantation.

Sarclisa is a CD38 monoclonal antibody designed to target multiple myeloma cells through apoptosis and immunomodulatory mechanisms. The drug is approved in over 50 countries, including the United States, European Union and Japan, across multiple indications. In China, Sarclisa is now approved in combination with VRd for front-line treatment in transplant-ineligible NDMM patients, as well as in combination with Pd for R/R MM patients.