Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 69

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 69
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 in Europe by the EC in May 2020 in combination with pomalidomide and dexamethasone for the treatment of adult patients with RRMM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. Sarclisa is now approved for this indication in more than 50 countries. In early 2025 Sarclisa, in combination with pomalidomide and dexamethasone, was approved by the NMPA (National Medical Products Administration) in China for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior line including lenalidomide and proteasome inhibitor. This is the first indication of Sarclisa to be approved in China. Sarclisa was approved in the US in March 2021 for a label extension in combination with carfilzomib and dexamethasone for the treatment of adults with RRMM who have received one to three prior lines of therapy, and in Europe in April 2021 by the EC for the treatment of adult patients with MM who have received at least one prior therapy. The Japanese Ministry of Health, Labor

| 28 | SANOFIFORM 20-F2024 |

| PART I                             |
| ITEM 4. Information on the Company |

and Welfare (MHLW) granted approval for Sarclisa in November 2021 in combination with carfilzomib and dexamethasone, in combination with dexamethasone, and as monotherapy for RRMM patients. Sarclisa was approved in the US in September 2024, in Europe in January 2025, and (as the second indication) in China in January 2025 in combination with bortezomib, lenalinomide and dexamethasone for the treatment of adults with newly diagnosed MM who are not eligible for autologous stem cell transplant (ASCT). ANVISA, the Brazilian healthcare authority, also approved Sarclisa in the same combination for the treatment of adult patients with newly diagnosed MM who are not eligible for ASCT or with no intent for ASCT as initial therapy. This additional label has also been submitted to other regulatory authorities, and is currently being reviewed. In addition, the Phase 3 IRAKLIA study investigating the development of a new subcutaneous formulation with an on-body device system, which w as initiated in the second half of