Press Release: Sanofi's Qfitlia and Cablivi approved in China, expanding care for rare diseases

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] Group 1: Qfitlia - Qfitlia is the first antithrombin-lowering therapy for routine prophylaxis in hemophilia patients aged 12 and older, significantly reducing bleeding episodes [2][3] - The approval is based on ATLAS phase 3 studies showing a 71% reduction in annualized bleeding rates (ABR) for patients without inhibitors and a 73% reduction for patients with inhibitors [9] - Qfitlia requires as few as six subcutaneous injections per year, making it a more accessible treatment option for hemophilia patients [7][10] Group 2: Cablivi - Cablivi is the first targeted therapy for treating aTTP in adults and adolescents, addressing a critical unmet need in this life-threatening condition [4][5] - 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, helping to prevent organ damage during the disease [5][18] Group 3: Sanofi's Commitment - The approvals of Qfitlia and Cablivi expand Sanofi's rare hematology portfolio in China, addressing significant unmet medical needs [6] - Sanofi emphasizes its commitment to delivering meaningful innovations and improving outcomes for patients with rare diseases [7] - The company aims to bring transformative medicines across diverse disease areas, reinforcing its long-term commitment to the Chinese market [1]