Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 72

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 72
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 infarction (MI), recent ischemic stroke or established peripheral arterial disease (PAD), and for patients with acute coronary syndrome (ACS). Plavix is also indicated in combination with acetylsalicylic acid (ASA) for the prevention of atherothrombotic and thromboembolic events in atrial fibrillation, including stroke.

| SANOFIFORM 20-F2024 | 29 |

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

CoPlavix/DuoPlavin, a fixed-dose combination of clopidogrel bisulfate and ASA, is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome who are already taking both clopidogrel and ASA. Several clopidogrel bisulfate generics have been launched in most markets. Plavix or Iscover are available in more than 110 countries. Sanofi is involved in two Plavix medicine lawsuits. See Note D.22.c) to our consolidated financial statements, included at Item 18. of this annual report. Rezurock Rezurock (belumosudil) is a first-in-class selective ROCK2 (rho-associated coiled-coil–containing protein kinase-2) inhibitor. It was approved in July 2021 by the FDA for the treatment of adult and pediatric patients aged 12 years and older with chronic graft- versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy. In addition to robust adoption in the United States, Rezurock has been launched in 10 countries including Canada, the United Kingdom, China, Japan and South Korea (marketed in Japan and South Korea by partner Romeck Pharma). Early access or managed access programs are available in 28 countries, including European Union countries and Turkey. On November 28, 2024, Sanofi achieved the inclusion of Rezurock on the new National Reimbursement Drug List in China, via a thorough process recognizing the clinical and pharma-economic value of the medicine. The new list became effective on January 1, 2025. Rezurock’s favorable market adoption, longer durability of response, and recent three-year safety publication, especially in US patients, are a reflection of its clinical profile. Sanofi is currently developing an oral suspension to support pediatric studies. Two belumosudil Phase 3 clinical studies are currently enrolling patients for the treatment of (i) newly