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Hyrnuo

Hyrnuo (sevabertinib) is an oral targeted therapy used to treat adults with locally advanced or metastatic non-squamous non–small cell lung cancer (NSCLC) that has HER2 (ERBB2) tyrosine kinase domain activating mutations. It is prescribed after patients have received at least one prior systemic therapy. Hyrnuo works by blocking HER2-driven tumor growth and is taken twice daily with food.

The information outlined in the molecule details section below would help you evaluate Para IV filing opportunities early to secure a first-to-file advantage.

Molecule Details :

  • Molecule Name :

    Sevabertinib
  • Innovator :

    BAYER HEALTHCARE PHARMACEUTICALS INC
  • Approval Date :

    19-Nov-25
  • NCE-1 Date :

    19-Nov-29
  • NCE Date :

    19-Nov-30
  • Dosage Form :

    Oral Tablet
  • Strength :

    10MG
  • Therapeutic Category :

    Anticancer
  • Revenue ($M) :

    NA

Year-wise Projected Sales ($M) :

  • 2025 :

    NA
  • 2026 :

    NA
  • 2027 :

    NA
  • 2028 :

    17
  • 2029 :

    43
  • 2030 :

    65
  • 2031 :

    91
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