Wedoany.com Report-Dec.13, China's National Medical Products Administration has approved two Sanofi treatments for rare blood disorders: Qfitlia (fitusiran) for haemophilia and Cablivi (caplacizumab) for acquired thrombotic thrombocytopenic purpura (aTTP).

The approvals mark the fourth and fifth clearances for Sanofi in the country in 2025.

These decisions represent the fourth and fifth regulatory clearances Sanofi has obtained in the country during 2025.

Qfitlia serves as an antithrombin-reducing therapy for routine prophylaxis in haemophilia patients. It aims to prevent or decrease bleeding episodes in individuals aged 12 years and older with haemophilia A or B, including those with or without inhibitors to factor VIII or IX.

Approval relied on results from the ATLAS Phase III studies, demonstrating substantial bleed protection based on annualised bleeding rates across patient groups with or without inhibitors.

The treatment functions by reducing antithrombin levels—a protein that limits blood clotting—thus promoting thrombin production and supporting balanced haemostasis in affected individuals.

Qfitlia gained authorization from the United States Food and Drug Administration in March 2025 for similar prophylactic use in adults and adolescents aged 12 and above. Additional applications are under evaluation in various jurisdictions.

Cablivi is a targeted nanobody therapy for adults and adolescents aged 12 years or older (weighing at least 40 kg) with acquired or immune-mediated thrombotic thrombocytopenic purpura.

The product is currently accessible in 30 countries and regions, such as Brazil, the United Kingdom, the European Union, the United States, Switzerland, and several locations in the Greater Gulf area.

Its review in China followed a priority pathway. A proposed extension to include adolescents has also received priority consideration from the United States Food and Drug Administration.

Sanofi executive vice president, head of speciality care Brian Foard stated: "Qfitlia represents a potentially transformative advancement for the haemophilia community in China, shifting care from treating bleeds as they occur to helping prevent them altogether. By offering effective bleed protection and simplified administration, Qfitlia has the potential to make prophylaxis more accessible for people with haemophilia worldwide.

"Cablivi addresses a critical unmet need for patients facing aTTP/iTTP. Together, these approvals highlight Sanofi's commitment to delivering meaningful innovation and improving outcomes for people living with rare diseases in China and around the world."

These advancements expand treatment options for patients managing these conditions, reflecting continued progress in specialised medical therapies.