Sarclisa is the first anti-CD38 treatment approved in China for patients with newly diagnosed multiple myeloma ineligible for transplant 

• Approval based on positive results from the IMROZ phase 3 study that demonstrated Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) significantly improved progression-free survival, compared to VRd alone in transplant-ineligible newly diagnosed multiple myeloma 
• Second approval in China in three weeks following the R/R MM indication announced on January 13, 2025

The National Medical Products Administration (NMPA) in China has approved Sarclisa, in combination with a standard-of-care regimen, bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplant (ASCT) based on data from the IMROZ phase 3 study.

Olivier Nataf
Global Head, Oncology
“When Sanofi entered China more than four decades ago, we did so with the intention of bringing potentially transformative therapies to Chinese patients. This approval, occurring just weeks after Sarclisa’s first in the country, represents tremendous progress towards advancing this mission. Now, patients with multiple myeloma and their providers have access to two new Sarclisa-based regimens that have the potential to improve outcomes across lines of therapy.”

This approval closely follows the decision from the NMPA earlier in January 2025, approving Sarclisa in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with relapsed or refractory MM (R/R MM) who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. Beyond China, in the Asia-Pacific region, a regulatory submission for Sarclisa in NDMM patients not eligible for hematopoietic stem cell transplantation (HSCT) is currently under review in Japan.