Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 75

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 75
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 in combination with metformin with or without SGLT-2 inhibitors for the treatment of adults with type 2

| 30 | SANOFIFORM 20-F2024 |

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

diabetes to improve glycemic control, when this had not been provided either by metformin alone or by metformin combined with another oral glucose-lowering medicine or with basal insulin. In Japan, Soliqua was approved in May 2020 for type 2 diabetes mellitus, where treatment with insulin is required. In China, Soliqua was approved in January 2023 for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycemic control as an adjunct to diet and exercise in addition to other oral antidiabetic drugs. Soliqua received National Reimbursement Drug List (NRDL) status in China in December 2023. Suliqua is available in over 40 countries. Soliqua is approved in over 80 countries. Mozobil Mozobil (plerixafor injection) is a hematopoietic stem cell mobilizer. It is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma (NHL) and MM. Mozobil is marketed in over 65 countries. Generic Mozobil has been available in the US since the end of 2023, and in Europe since 2024. Tzield Tzield (Teplizumab) is a CD3-directed antibody (CD3 is a cell surface antigen present on T lymphocytes). It was approved by the FDA in November 2022 to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged eight years and older with Stage 2 type 1 diabetes. The medicine is currently marketed in the United States, and approved in Israel and the United Arab Emirates in this indication, with plans for pursuing regulatory approval in other regions such as the EU, China and Japan. The medicine is currently in development for further indications for the treatment of patients already in Stage 3 (clinical onset) type 1 diabetes, as well as for pediatric patients ages 0-7 at Stages 2 and 3 type 1 diabetes. Early access programs and Managed Access Programs are available in France,