Overview
- The NMPA authorized Qfitlia for routine prophylaxis in patients 12 or older with severe hemophilia A, supported by ATLAS Phase 3 data.
- ATLAS results showed a 71% reduction in annualized bleeding rates for patients without inhibitors and a 73% reduction for those with inhibitors, with many patients maintained on six injections per year.
- Cablivi gained approval for acquired thrombotic thrombocytopenic purpura in adolescents and adults aged 12 or older who weigh at least 40 kg as an adjunct to plasma exchange plus immunosuppressive therapy.
- The nanobody targets von Willebrand factor to limit microthrombus formation and is the first therapy of its kind for aTTP in China.
- These approvals are Sanofi’s fourth and fifth in China in 2025, with reported patient pools of about 40,000 for hemophilia and roughly 2,700 aTTP diagnoses annually, and Sanofi shares rose modestly on the announcement.