Sanofi announced that China’s National Medical Products Administration has granted market authorization for its two rare‑disease therapies, Qfitlia (fitusiran) and Cablivi (caplacizumab), on December 11 2025. Qfitlia is a small‑interfering RNA drug that lowers antithrombin to restore thrombin generation, making it the first antithrombin‑lowering therapy for routine prophylaxis in patients with severe hemophilia A or B, including those with inhibitors. Cablivi is a nanobody that targets von Willebrand factor to prevent microthrombi in acquired thrombotic thrombocytopenic purpura (aTTP).
The approvals come at a time when China’s rare‑disease market is expanding, with more than 40,000 hemophilia patients and an estimated 2,700 new aTTP cases each year. By adding Qfitlia and Cablivi to its portfolio, Sanofi positions itself to capture a significant share of these unmet needs, reinforcing its specialty‑care strategy and diversifying revenue beyond its traditional vaccine and general‑medicine businesses.
Sanofi’s Qfitlia was approved based on phase 3 ATLAS studies that demonstrated clinically meaningful reductions in annualized bleeding rates, while Cablivi’s approval follows its prior success in the U.S. and Europe. The company’s acquisition of Ablynx in 2018, the original developer of Cablivi, has now yielded a new product line in a high‑growth market. These approvals also mark Sanofi’s fourth and fifth drug approvals in China in 2025, following Tzield for type 1 diabetes and Sarclisa for multiple myeloma.
Strategically, the approvals strengthen Sanofi’s rare‑disease focus and support its goal of growing specialty care. The company’s Q3 2025 results showed a modest revenue increase to €12.434 billion, driven by strong performance in specialty segments, while net income remained stable at €2.802 billion. The new China approvals are expected to accelerate growth in the specialty‑care segment and provide a new revenue stream in a market with high unmet need.
Management emphasized its commitment to China, noting that the approvals “demonstrate Sanofi’s ability to bring transformative medicines to patients in China and reinforce our long‑term strategy to expand specialty care worldwide.” The approvals are expected to enhance Sanofi’s competitive position in rare‑disease markets and support its broader growth objectives.
The market reaction to the approvals has been positive, with analysts noting the significant market potential and Sanofi’s strategic alignment with China’s expanding rare‑disease sector. The approvals are expected to contribute to the company’s specialty‑care revenue growth and reinforce its long‑term growth trajectory.
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