Drug Profile

Poziotinib - Hanmi Pharmaceutical

Alternative Names: HM-781-36; HM-781-36B; HM-781-36B hydrochloride; NOV-1201; NOV-120101; Poziotinib hydrochloride - Hanmi Phamaceutical

Latest Information Update: 05 Aug 2026

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At a glance

Originator Hanmi Pharmaceutical
Developer Assertio Therapeutics; Chonnam National University Hospital; Chungnam National University; Hanmi Pharmaceutical; Konkuk University Medical Center; Korean Association for the Study of Targeted Therapys; Kosin University Gospel Hospital; Kyungpook National University Medical School; Spectrum Pharmaceuticals; University of Texas M. D. Anderson Cancer Center; Zydus Lifesciences
Class Anilinouracils; Antineoplastics; Piperidines; Quinazolines; Small molecules
Mechanism of Action Erb-b2 receptor tyrosine kinase antagonists; ERBB 4 receptor antagonists; ErbB receptor antagonists

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity Yes
Available For Licensing Yes

Phase III Non-small cell lung cancer
Suspended Colorectal cancer; Glioma; HER2 positive breast cancer; Lung cancer; Solid tumours
Discontinued Gastric cancer; Head and neck cancer

05 Aug 2026 Discontinued - Phase-II for Gastric cancer (Combination therapy) in South Korea (PO)
05 Aug 2026 Discontinued - Phase-II for HER2-positive-breast-cancer (Second-line therapy or greater, Late-stage disease, Metastatic disease) in South Korea (PO) (Hanmi pipeline, July 2026)
05 Aug 2026 Discontinued - Phase-II for Non-small cell lung cancer (Second-line therapy or greater, Metastatic disease, Late-stage disease) in South Korea (PO)

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