R&D Leadership and Organization - Sanofi is building a skilled and thoughtful R&D leadership team and organization[5, 6, 7, 106] - The company is strengthening capabilities across research, translational medicines, development, medical, regulatory affairs, and digital[106] Pipeline Highlights and Approvals - Sanofi achieved three new medicine and vaccine approvals in 2025: Qfitlia, Wayrilz, and Nuvaxovid[12, 13, 106] - Dupixent showed benefit across relevant endpoints in Bullous pemphigoid, with 12.2% difference in patients achieving sustained remission compared to placebo + OCS and 27.8% difference in patients with ≥4-point improvement in PP-NRS[20, 21] - Dupixent clinically meaningfully improved radiographic, endoscopic, and symptoms of Allergic fungal rhinosinusitis, with lower proportion of patients receiving SCS treatment and/or surgery[24] - Amlitelimab (OX40L mAb) in AD: first phase 3 study met primary and key secondary endpoints, showing clinically meaningful improvement in skin clearance and disease severity[26] - Brivekimig (TNFaxOX40L Nanobody®) in HS: phase 2a study achieved primary objective, with 54% of participants achieving HiSCR75[28, 29] - Itepekimab (IL33 mAb) in COPD: AERIFY-1 study showed a significant reduction in moderate or severe exacerbations of 27.1% at Week 52 with Q2W dosing across EOS level[38] - Duvakitug (TL1A mAb) in CD/UC: positive and encouraging phase 2b data presented at ECCO 2025, with 48% clinical remission in Crohn's disease high dose group[46, 47] - Fluzone HD demonstrated superior protection vs standard-dose influenza vaccines against hospitalization in older adults, including a -31.9% reduction in laboratory confirmed influenza hospitalization[75] - Monovalent RSV (mRNA) vaccine showed 74.9% efficacy against RSV LRTD in a phase 2 study[80] Pipeline Replenishment and Digital Transformation - Sanofi is progressing on pipeline entries augmented by strategic business development[107] - The R&D digital plan aims at reducing cycle times across the R&D value chain by more than 40%[94, 95, 107] Upcoming News Flow - Sanofi anticipates >15 regulatory decisions, >30 regulatory submissions, and >15 phase 3 data readouts in 2026 and 2027[108]

Two bleeding disorder treatments for both chronic and acute conditions, Qfitlia and Cablivi, have been approved in China. https://t.co/jYTwWsGrU4 ...

Core Insights - Two treatments for bleeding disorders, Qfitlia and Cablivi, have received approval in China [1] Group 1 - Qfitlia is indicated for chronic bleeding disorders [1] - Cablivi is indicated for acute bleeding disorders [1]

Core Insights - The National Medical Products Administration (NMPA) in China has approved two innovative Sanofi medicines for rare hematologic diseases: Qfitlia for hemophilia and Cablivi for acquired thrombotic thrombocytopenic purpura (aTTP) [1] - These approvals represent Sanofi's fourth and fifth approvals in China for the year, following Tzield and Sarclisa [1] Qfitlia Overview - Qfitlia is the first antithrombin-lowering therapy for routine prophylaxis in hemophilia patients aged 12 and older, including those with severe hemophilia A or B [2] - The approval is based on ATLAS phase 3 studies showing significant reductions in annualized bleeding rates (ABR) for patients treated with Qfitlia [3] - Qfitlia utilizes small-interfering RNA technology, allowing for low treatment frequency and subcutaneous administration [3][15] - Hemophilia affects over 40,000 individuals in China, highlighting the need for effective treatment options [3] Cablivi Overview - Cablivi is the first targeted therapy for treating aTTP in adults and adolescents aged 12 or older [4] - Approximately 2,700 patients are diagnosed with aTTP annually in China, with a mortality rate of up to 20% despite standard treatments [5] - Cablivi works by inhibiting the interaction between von Willebrand factor and platelets, thus preventing microthrombi formation [5][18] Market Impact - The approvals of Qfitlia and Cablivi expand Sanofi's rare hematology portfolio in China, addressing critical unmet needs in chronic bleeding disorders and acute clotting emergencies [6] - Sanofi's commitment to innovation is emphasized by these approvals, aiming to improve outcomes for patients with rare diseases [7] Clinical Results - Qfitlia demonstrated a 71% reduction in ABR for patients without inhibitors and a 73% reduction for patients with inhibitors compared to traditional treatments [9] - In the open-label extension study, nearly 80% of participants were on a regimen of six injections per year, with 94% achieving target AT levels [17]

Core Insights - Sanofi's Specialty Care division is positioned for significant growth, focusing on immunology, oncology, neurology, and rare diseases [3][4] - The company anticipates dupilumab to achieve a compound annual growth rate (CAGR) in the double digits from 2023 to 2030, potentially generating around EUR 22 billion by 2030 [4] Company Overview - Sanofi has streamlined its business units from four to three following the sale of its Consumer Health Opella, now comprising General Medicines, Vaccines, and Specialty Care [3] - The Specialty Care business unit is expected to drive growth through recently launched products such as ALTUVIIIO and Qfitlia, alongside the expanding indications for SARCLISA in oncology and multiple myeloma [4]