Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 53

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 53
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, Dupixent was approved by the EC as the first and only targeted medicine for children as young as six months old with severe AD. On January 22, 2018, the Ministry of Health, Labor and Welfare (MHLW) in Japan granted marketing and manufacturing authorization for Dupixent for the treatment of AD in adults not adequately controlled with existing therapies. More recently, on September 25, 2023 Dupixent was approved in Japan to treat patients aged six months and older with moderate-to-severe AD. On June 19, 2020, the National Medical Products Administration (NMPA) in China approved Dupixent for adults for the treatment of moderate-to-severe AD after identifying dupilumab as an overseas medicine regarded as urgently needed in clinical practice, leading to an expedited review and approval process. On December 28, 2020, the National Healthcare Security Administration (NHSA) officially announced the results of the 2020 National Reimbursement Drug List (NRDL) negotiations, with Dupixent 300 mg included in the updated NRDL effective March 1, 2021. Dupixent was approved in China in September 2021 for adolescents aged 12-17 years with moderate-to-severe AD. The indication for children aged six years and over, along with the adolescent and adult AD indications, was included in the current NRDL reimbursement scope, which was reviewed during the Dupixent NRDL renewal in 2022 in accordance with the two-year cycle for the China access process. In May 2023, Dupixent was approved in China to treat moderate to severe AD in infants and children aged six months and older. In April 2023, new abstract data from a long-term efficacy open-label study presented at the Revolutionizing Atopic Dermatitis (RAD) 2023 Spring Conference in Washington, DC showed that Dupixent demonstrated robust and sustained efficacy with progressive improvement of AD signs and symptoms in patients with moderate-to-severe AD who completed up to five years of treatment: the longest duration of data for any biologic medicine in this disease. Additionally, the long-term safety data from a 52-week open-label extension study in children aged six months to five years reinforced the well-established safety profile of Dupixent observed across all other approved age groups. These data build on the existing evidence supporting the selective way

| 22 | SANOFIFORM 20-F2024 |

| PART I                             |
| ITEM 4. Information on