Sanofi wins China approval for Qfitlia and Cablivi

Chinese regulator the National Medical Products Administration (NMPA) has approved two innovative medicines for rare hematologic diseases: Qfitlia (fitusiran) for hemophilia and Cablivi (caplacizumab) for acquired thrombotic thrombocytopenic purpura, both from French pharma major Sanofi (Euronext: SAN).

These approvals mark another step in Sanofi’s long-term commitment to China, reinforcing the company’s ambition to bring transformative medicines across diverse disease areas. With Qfitlia and Cablivi, Sanofi reaches its fourth and fifth approvals in China this year, following Tzield (teplizumab for stage 2 type 1 diabetes and Sarclisa (isatuximab) for two indications in relapsed and newly diagnosed multiple myeloma.

Qfitlia is the first antithrombin (AT)-lowering therapy for routine prophylaxis in people with hemophilia. Qfitlia is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in pediatric patients 12 years of age and older, and adults with severe hemophilia A (coagulation factor VIII deficiency, FVIII<1%) with or without factor VIII inhibitors, or severe hemophilia B (coagulation factor IX deficiency, FIX<1%) with or without factor IX inhibitors.