Development Pipeline

Development Pipeline

ROLONTIS® (eflapegrastim)

An investigational long-acting granulocyte colony-stimulating factor (G-CSF) for the treatment of chemotherapy-induced neutropenia. The Biologics License Application (BLA) was filed in December, 2019, with a PDUFA date of October 24, 2020.

  • Chemotherapy-Induced Neutropenia (RECOVER, ADVANCE)
    Preclinical Phase 1 Phase 2 Phase 3 Approved
  • Same-day dosing
    Preclinical Phase 1 Phase 2 Phase 3 Approved
  • Pediatric patients treated with myelosuppressive chemotherapy
    Preclinical Phase 1 Phase 2 Phase 3 Approved
For more information click here.

Poziotinib

An investigational orally administered, irreversible tyrosine kinase inhibitor (TKI) for the treatment of solid tumors.

  • Previously treated EGFR exon 20 insertion mutation positive non-small cell lung cancer (NSCLC)
    Preclinical Phase 1 Phase 2 Phase 3 Approved
  • Previously treated HER2 exon 20 insertion mutation positive NSCLC
    Preclinical Phase 1 Phase 2 Phase 3 Approved
  • Treatment naïve EGFR exon 20 insertion mutation positive NSCLC
    Preclinical Phase 1 Phase 2 Phase 3 Approved
  • Treatment naïve HER2 exon 20 insertion mutation positive NSCLC
    Preclinical Phase 1 Phase 2 Phase 3 Approved
  • Previously first-line osimertinib treated NSCLC with acquired EGFR mutations (Exploratory)
    Preclinical Phase 1 Phase 2 Phase 3 Approved
  • Previously treated atypical EGFR or HER2 mutation positive NSCLC (Exploratory)
    Preclinical Phase 1 Phase 2 Phase 3 Approved
For more information click here.

IGN002

An investigational Interferon/CD20 Monoclonal Antibody Fusion Protein

  • Refractory Non-Hodgkin Lymphoma (NHL)
    Preclinical Phase 1 Phase 2 Phase 3 Approved