China’s NMPA Clears Two Sanofi Treatments for Rare Hematologic Diseases
Qfitlia and Cablivi are authorized for hemophilia and acquired thrombotic thrombocytopenic purpura, respectively, marking the company's latest approvals in China for 2025.
China’s National Medical Products Administration (NMPA) has granted approvals for two of Sanofi’s rare hematologic disease treatments: Qfitlia (fitusiran) and Cablivi (caplacizumab). These authorizations represent the fourth and fifth clearances for the company in China during 2025.
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Qfitlia (Fitusiran)
Qfitlia is an antithrombin-lowering therapy indicated for routine prophylaxis in individuals with hemophilia. 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 hemophilia A or B, regardless of the presence of factor VIII or IX inhibitors.
The NMPA’s decision is supported by data from the Phase III ATLAS trials, which demonstrated meaningful protection against bleeding across patients, measured by the annualised bleeding rate. Qfitlia functions by lowering antithrombin, a protein that inhibits blood clotting, thereby increasing thrombin generation and helping restore hemostasis in patients. The treatment was also approved by the U.S. Food and Drug Administration (FDA) in March 2025 for routine prophylaxis in patients aged 12 years and older.
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Cablivi (Caplacizumab)
Cablivi is a nanobody-targeted therapy approved for acquired or immune-mediated thrombotic thrombocytopenic purpura (aTTP/iTTP) in adults and adolescents aged 12 years or above weighing at least 40 kg.
The therapy is currently available in 30 countries and regions globally. Cablivi 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.
A Sanofi executive noted that Qfitlia represents a potentially transformative advancement for the hemophilia community in China, shifting care toward prevention rather than just treating bleeds when they occur. Simultaneously, Cabliviaddresses a critical unmet need for patients facing aTTP/iTTP.
Source: https://www.pharmaceutical-technology.com/news/china-sanofi-haematologic-disease/?cf-view
