China’s National Medical Products Administration (NMPA) has granted approval for Sanofi’s rare haematologic disease treatments, Qfitlia (fitusiran) and Cablivi (caplacizumab), for patients with haemophilia and acquired thrombotic thrombocytopenic purpura (aTTP) respectively.
The approvals mark the fourth and fifth clearances for the company in the country in 2025.
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Qfitlia is the antithrombin-lowering therapy indicated for routine prophylaxis in individuals with haemophilia.
It is intended for the prevention or reduction of bleeding episodes in patients aged 12 years and above, as well as in adults with severe haemophilia A or B with or without factor VIII or IX inhibitors.
The NMPA’s decision is supported by the data from the ATLAS Phase III trials, which showed meaningful protection against bleeding, as per annualised bleeding rate measurements, in patients with or without inhibitors.
Qfitlia works by lowering antithrombin, a protein that inhibits the clotting of blood, thereby increasing the generation of thrombin and helping restore haemostasis in haemophilia patients.
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By GlobalDataIn March 2025, Qfitlia secured approval from the US Food and Drug Administration (FDA) for routine prophylaxis in adult and paediatric patients aged 12 years and older.
Further regulatory submissions for the therapy are being reviewed in other regions.
Cablivi is the nanobody-targeted therapy for treating acquired or immune-mediated thrombotic thrombocytopenic purpura (aTTP/iTTP) in adults and adolescents aged 12 years or above weighing at least 40 kg.
It is already available in 30 countries and regions, including Brazil, the UK, the European Union, the US, Switzerland and five states in the Greater Gulf region.
The therapy received priority review status for its approval in China and has also been granted priority review by the FDA for a proposed label expansion to include adolescents aged 12 and above.
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.”
