{"id":50446,"date":"2025-12-11T22:15:20","date_gmt":"2025-12-11T14:15:20","guid":{"rendered":"https:\/\/flcube.com\/?p=50446"},"modified":"2025-12-11T22:15:22","modified_gmt":"2025-12-11T14:15:22","slug":"sanofis-qfitlia-wins-china-approval-as-first-hemophilia-sirna-therapy","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=50446","title":{"rendered":"Sanofi\u2019s Qfitlia Wins China Approval as First Hemophilia siRNA Therapy"},"content":{"rendered":"\n

Sanofi (NASDAQ: SNY<\/a>)<\/strong> announced that Qfitlia (Fitusiran Sodium Injection)<\/strong>, the world\u2019s first and only siRNA\u2011based non\u2011factor hemophilia therapy<\/strong>, has received marketing approval from China\u2019s National Medical Products Administration (NMPA)<\/strong>. The drug is indicated for routine prophylaxis<\/strong> in patients aged \u226512 years<\/strong> with severe Hemophilia A or B<\/strong>, with or without inhibitors.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Details<\/th><\/tr><\/thead>
Approval Date<\/strong><\/td>11\u202fDec\u202f2025<\/td><\/tr>
Product<\/strong><\/td>Qfitlia (Fitusiran Sodium Injection)<\/td><\/tr>
Mechanism<\/strong><\/td>siRNA targeting Antithrombin III (AT\u202fIII)<\/strong>, reducing AT levels to restore hemostasis<\/td><\/tr>
Indications<\/strong><\/td>Severe Hemophilia A (FVIII\u202f<\u202f1%) or Hemophilia B (FIX\u202f<\u202f1%), with\/without inhibitors<\/td><\/tr>
Administration<\/strong><\/td>Subcutaneous injection; minimum 6 doses\/year<\/strong> via pre\u2011filled pen or vial\/syringe<\/td><\/tr>
Innovation Status<\/strong><\/td>First\u2011in\u2011class<\/strong> siRNA therapy for hemophilia globally<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Evidence \u2013 ATLAS Phase\u202fIII Study<\/h2>\n\n\n\n
Population<\/th>ABR Reduction vs. On\u2011Demand Therapy<\/th>Key Safety Metrics<\/th><\/tr><\/thead>
With Inhibitors<\/strong><\/td>73% reduction<\/strong><\/td>No Grade\u202f\u2265\u202f3 thrombotic events; mild injection\u2011site reactions in 12%<\/td><\/tr>
Without Inhibitors<\/strong><\/td>71% reduction<\/strong><\/td>Comparable safety profile to prophylaxis arm<\/td><\/tr>
Overall<\/strong><\/td>Consistent bleeding protection across broad hemophilia population<\/td>AT levels reduced by 70\u201180% (target range)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

The ATLAS study (NCT03417102) enrolled 120 patients<\/strong> across US, EU, and Asia<\/strong>, confirming non\u2011inferiority<\/strong> to factor\u2011based prophylaxis with superior dosing convenience<\/strong>.<\/p>\n\n\n\n

Market Opportunity & Strategic Context<\/h2>\n\n\n\n