Sanofi’s Hematology Push in China: Qfitlia and Cablivi Approved

Sanofi announced that China’s National Medical Products Administration (NMPA) has approved two rare-hematology medicines — Qfitlia (fitusiran) for hemophilia and Cablivi (caplacizumab) for acquired thrombotic thrombocytopenic purpura (aTTP). According to Sanofi, these approvals bring the company’s total regulatory greenlights in China in 2025 to five, following earlier approvals including Sarclisa (isatuximab) and Tzield (teplizumab). Qfitlia is positioned as a low-frequency, antithrombin-lowering prophylactic for people with hemophilia A or B; Cablivi is a Nanobody therapy indicated for aTTP alongside plasma exchange and immunosuppression. The approvals expand access to advanced hematology treatments in China and reinforce Sanofi’s strategic focus on rare and specialty medicines in the market.

Sanofi’s Bleeding-Disorder Treatments Approved in China — What Happened and Why It Matters

Sanofi confirmed on December 11, 2025 that China’s regulator, the NMPA, has approved Qfitlia (fitusiran) and Cablivi (caplacizumab) — two therapies that address chronic bleeding disorders and acute clotting emergencies, respectively. Sanofi’s announcement says these approvals raise the company’s tally of Chinese approvals for 2025 to five.

The two approvals: what each drug does

1.Qfitlia (fitusiran) — an antithrombin-lowering RNAi therapy intended for routine prophylaxis in people with severe hemophilia A or B (with or without inhibitors). Qfitlia’s regimen can be administered with as few as six subcutaneous injections per year and was shown in phase 3 ATLAS studies to substantially reduce annual bleeding rates. Sanofi positions Qfitlia as a first-in-class option in China for non-factor prophylaxis.

2. Cablivi (caplacizumab) — a Nanobody that targets von Willebrand factor (vWF) to prevent microthrombi formation in acquired thrombotic thrombocytopenic purpura (aTTP). Approved for use alongside plasma exchange and immunosuppression, Cablivi provides a targeted option for a rare, life-threatening clotting disorder.

Both approvals expand Sanofi’s rare-disease and hematology portfolio in China and address distinct clinical needs: long-term bleed prevention in hemophilia, and acute intervention for aTTP.

How many approvals has Sanofi received in China this year?

Sanofi’s press release explicitly states that, with Qfitlia and Cablivi, the company has reached its fourth and fifth approvals in China during 2025 — citing earlier approvals including Sarclisa (isatuximab) in multiple myeloma and Tzield (teplizumab) for stage-2 type 1 diabetes. Independent wire coverage and financial news outlets reporting on Sanofi’s announcement corroborate the “five approvals” figure.

Why these approvals matter for patients in China

A. Increased access to advanced care: Qfitlia’s low-frequency dosing could markedly reduce treatment burden for people with hemophilia who require life-long prophylaxis, while Cablivi fills an urgent need for aTTP management. Sanofi’s release cites patient-population estimates and clinical data showing significant reductions in bleeding rates with Qfitlia.

B. Ecosystem impact: New approvals of specialty biologics can drive improvements in diagnostic pathways, reimbursement discussions, and clinician familiarity with advanced hematology care in China.

Market and strategic implications

1. Sanofi’s China strategy: The cluster of approvals in 2025 underscores Sanofi’s focus on specialty and rare-disease medicines in China — a market that has been accelerating regulatory reform and opening faster pathways for innovative therapies.

2. Competitive landscape: Qfitlia enters a competitive global hemophilia market that includes factor-replacement therapies and gene-therapy entrants. Its differentiator in many jurisdictions is a lower dosing frequency and a non-factor mechanism of action. Cablivi offers a targeted acute therapy for aTTP — an area of significant clinical need despite small patient numbers.

Safety and labeling notes

Sanofi’s release reiterates safety considerations: Qfitlia has been associated with serious thrombotic events and other adverse reactions in trials, and its use requires careful patient selection and monitoring. Cablivi is indicated for acute use with plasma exchange and immunosuppression; clinicians must follow local prescribing information. These safety points are central to post-approval clinical rollout and physician education. Reported on Sanofi

Conclusion

Sanofi’s December 11, 2025 NMPA approvals for Qfitlia and Cablivi are validated by the company’s official press release and supported by financial news coverage. Together with earlier 2025 approvals such as Sarclisa and Tzield, they bring Sanofi’s count of Chinese regulatory nods this year to five, reinforcing the company’s strategic push into rare and specialty medicines in China. These approvals expand options for patients with hemophilia and aTTP and will shape clinical practice and market dynamics in hematology across the region.