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Yartemlea

Yartemlea is a fully human monoclonal antibody that selectively inhibits mannan-binding lectin–associated serine protease-2 (MASP-2), a key enzyme in the lectin pathway of the complement system.

It is approved for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adults and pediatric patients aged two years and older. By blocking MASP-2, Yartemlea prevents complement-mediated endothelial injury while preserving other immune pathways essential for host defense. TA-TMA is a rare but often fatal complication of stem cell transplantation, and Yartemlea represents the first and only FDA-approved therapy targeting this pathway.

The information outlined in the molecule details section below would help you plan aBLA development early to enable a streamlined and competitive biosimilar strategy.

Molecule Details :

  • Molecule Name :

    Narsoplimab-Wuug
  • Innovator :

    OMEROS CORP
  • Approval Date :

    23-Dec-25
  • Data Exclusivity Expiry :

    23-Dec-29
  • Market Exclusivity Expiry :

    23-Dec-37
  • Dosage Form :

    Intravenous Injection
  • Strength :

    370MG/2ML
  • Therapeutic Category :

    Immunomodulator
  • Revenue ($M) :

    NA

Year-wise Projected Sales ($M) :

  • 2025 :

    NA
  • 2026 :

    12
  • 2027 :

    76
  • 2028 :

    177
  • 2029 :

    317
  • 2030 :

    362
  • 2031 :

    446
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