Sarclisa: A Breakthrough in Anti-CD38 Treatments for Multiple Myeloma in China

Sarclisa, an anti-CD38 monoclonal antibody developed by Sanofi, has made history by becoming the first treatment of its kind approved in China for patients with newly diagnosed multiple myeloma (NDMM) ineligible for transplant. This approval, announced on January 31, 2025, follows closely on the heels of another approval for Sarclisa in combination with pomalidomide and dexamethasone (Pd) for the treatment of relapsed or refractory multiple myeloma (R/R MM) in China, which was granted just three weeks prior. 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 NDMM ineligible for autologous stem cell transplant (ASCT) based on data from the IMROZ phase 3 study.

Olivier Nataf, Global Head of Oncology at Sanofi, expressed his enthusiasm about the approval, stating, "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."

The approval of Sarclisa in China is a significant milestone for Sanofi and the global market for anti-CD38 treatments in multiple myeloma. With a large patient population estimated to be around 300,000 in 2020, China represents a substantial market for innovative therapies like Sarclisa. The approval of Sarclisa in combination with VRd as a front-line treatment option in transplant-ineligible NDMM patients is particularly noteworthy, as it expands the reach of this innovative therapy to a larger patient population.

The approval of Sarclisa in China also highlights the growing importance of real-world evidence (RWE) in the regulatory landscape for innovative therapies and medical devices. Sarclisa was one of the first three treatments authorized for real-world studies as part of the Lecheng Pilot for real-world data application, and it is the first blood cancer treatment approved based on RWE, in addition to clinical data. This precedent-setting approval demonstrates the NMPA's commitment to leveraging RWE for accelerated reviews and approvals, potentially paving the way for other innovative therapies to follow suit.

In conclusion, the approval of Sarclisa in China represents a significant breakthrough in the global market for anti-CD38 treatments in multiple myeloma. With a large patient population and a growing emphasis on real-world evidence, China presents an attractive market for innovative therapies like Sarclisa. As Sanofi continues to advance Sarclisa as part of a patient-centric clinical development program, the potential long-term financial implications for the company are substantial, including increased revenue, market expansion, diversified revenue streams, potential cost savings, and enhanced brand recognition.