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Sanofi (SNY) Secures Approval for Cablivi in the US and Plozasiran in China
Yahoo Finance· 2026-01-16 17:12
Core Insights - Sanofi is recognized as a top blue-chip stock for investment in 2026, following the FDA's approval of Cablivi for pediatric patients with acquired thrombotic thrombocytopenic purpura (aTTP) [1] Group 1: Product Approvals - Cablivi was initially approved in 2019 for adults with aTTP and is notable for its effectiveness in treating rare blood disorders affecting 1 to 10 million children annually, with 80% of patients achieving clinical remission [2] - Sanofi has also received approval for plozasiran in China, aimed at reducing triglyceride levels in adult patients with familial chylomicronemia syndrome (FCS), following its approvals in the US and Canada [3][4] Group 2: Market Sentiment and Analyst Ratings - Jefferies maintained a Buy rating on Sanofi with a price target of €100, despite some investor concerns regarding management communication after the FDA's Complete Response Letter for tolebrutinib [4]
X @The Wall Street Journal
Two bleeding disorder treatments for both chronic and acute conditions, Qfitlia and Cablivi, have been approved in China. https://t.co/jYTwWsGrU4 ...
Sanofi's Bleeding-Disorder Treatments Get Approval in China
WSJ· 2025-12-11 06:42
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]
Press Release: Sanofi’s Qfitlia and Cablivi approved in China, expanding care for rare diseases
Globenewswire· 2025-12-11 06:00
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]