Poziotinib hydrochloride is a Small Molecule owned by Hanmi Pharmaceuticals, and is involved in 15 clinical trials, of which 9 were completed, 5 are ongoing, and 1 is planned.

Poziotinib is a pan-HER inhibitor. HM781-36B irreversibly inhibits EGFR (HER1 or ErbB1) including EGFR mutants, HER2 exon 20 mutation and HER4, thereby inhibiting the proliferation of tumor cells that over express these receptors. EGFRs, cell surface receptor tyrosine kinases, are often up regulated in a variety of cancer cell types and play key roles in cellular proliferation and survival.

The revenue for Poziotinib hydrochloride is expected to reach a total of $3.2bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Poziotinib hydrochloride NPV Report.

Poziotinib hydrochloride is originated and owned by Hanmi Pharmaceuticals. Spectrum Pharmaceuticals is the other company associated in development or marketing of Poziotinib hydrochloride.

Poziotinib hydrochloride Overview

Poziotinib (HM781-36B) is under development for the treatment of lung adenocarcinoma, esophageal cancer, HER2 exon 20–mutated non-small cell lung cancer and metastatic breast cancer (Her2-positive) and (Her2-negative). The drug candidate is administered orally as a tablet. It is a quinazoline-based irreversible pan-HER inhibitor with Exon 20 insertions. The drug candidate is based on the NCE (new chemical entities) discovery technology platform. It was also under development for gastric cancer including gastroesophageal junction adenocarcinoma, colorectal cancer, high-grade glioma, recurrent head and neck squamous cell carcinoma.

Spectrum Pharmaceuticals Overview

Spectrum Pharmaceuticals (Spectrum) is a biopharma company that acquires, develops, and commercializes novel drug candidates for treatment of cancer. The company’s pipeline products include ROLONTIS, for treatment of chemotherapy-induced neutropenia helps to reduce the frequency of multiplication of tumors. This product is in phase 3 trails.; Poziotinib, an irreversible tyrosine kinase inhibitor, for non-small cell lung cancer (NSCLC) tumors with various mutations. This product is in phase 2 trials and lead candidate for the organization. The company has R&D facilities in, Massachusetts and California, the US. The company operates in the US, Europe, Japan, and other countries. Spectrum is headquartered in Henderson, Nevada, the US.

The operating loss of the company was US$147.7 million in FY2021, compared to an operating loss of US$169.7 million in FY2020. The net loss of the company was US$158.6 million in FY2021, compared to a net loss of US$160.9 million in FY2020.

Quick View – Poziotinib hydrochloride

Report Segments
  • Innovator
Drug Name
  • Poziotinib hydrochloride
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
Key Companies
Highest Development Stage
  • Filing rejected/Withdrawn

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.