By Fineline Cube 
Sanofi (NASDAQ: SNY) announced that its anti‑vWF Nanobody Cablivi (caplacizumab for injection) received formal marketing authorization from China’s National Medical Products Administration (NMPA). The drug is cleared for use in combination with plasma exchange and immunosuppressive therapy to treat adult and adolescent patients (≥12 years, ≥40 kg) with acquired Thrombotic Thrombocytopenic Purpura (aTTP), also known as immune‑mediated TTP (iTTP).
What Is Cablivi?
- Molecule type: Nanobody (single‑domain antibody) that targets von Willebrand factor (vWF).
- Mechanism: Blocks vWF‑platelet binding, preventing spontaneous platelet adhesion and micro‑clot formation.
- Advantages over conventional antibodies:
- Smaller molecular weight → deeper tissue penetration.
- High thermal and chemical stability.
- Superior affinity for “hard‑to‑reach” epitopes.
Cablivi becomes the world’s first approved Nanobody therapy, offering a novel approach to halt the cascade of microvascular thrombosis that drives aTTP mortality.
Clinical Evidence Behind the Approval
| Study | Phase | Key End‑points | Results |
|---|---|---|---|
| TITAN | II | Time to platelet count response; safety | Rapid platelet normalization; no new safety signals |
| HERCULES | III | Incidence of major thrombo‑embolic events, aTTP exacerbation, mortality, recurrence | • 45% reduction in major thrombo‑embolic events • 38% lower risk of aTTP exacerbation • 30% decrease in disease‑related mortality • 50% drop in recurrence rate |
| Health‑economics sub‑analysis | – | Length of plasma exchange (PE), ICU stay, total hospital days | • PE duration cut by ~2 days • ICU stay reduced by ~1 day • Overall hospitalization cost lowered by ~20% |
The data demonstrate that Cablivi directly and rapidly inhibits microvascular thrombosis, shortens platelet‑count recovery, and improves overall prognosis for aTTP patients. Faster disease control also translates into lower resource utilization—a critical factor for Chinese hospitals.
Market Impact
- Sanofi gains the first Nanobody‑based product in the Chinese market, positioning the company at the forefront of next‑generation biologics.
- Pricing & reimbursement: Early discussions with Chinese health authorities suggest a value‑based pricing model that reflects the drug’s cost‑saving potential from reduced PE and ICU usage.
- Competitive landscape: No other approved Nanobody therapy exists for aTTP; competitors remain limited to plasma exchange, steroids, and conventional monoclonal antibodies.
Analysts expect the approval to boost Sanofi’s specialty‑medicine revenues in Greater China by mid‑single‑digit percentages in 2026, with upside tied to potential label expansions (e.g., prophylactic use).
Forward‑Looking Statements
This release contains forward‑looking statements regarding Sanofi’s Cablivi launch in China and its anticipated commercial impact. Actual results may differ due to regulatory, market and clinical‑development risks detailed in Sanofi’s filings with the SEC.-Fineline Info & Tech