Drug Profile

Eflapegrastim - Hanmi Pharmaceutical/Assertio Therapeutics

Alternative Names: Eflafegrastim; eflapegrastim-xnst; HM-10460A; HNK-460; LAPS-GCSF; Long-acting G-CSF analogue; ROLONTIS; ROLVEDON; SPI-2012

Latest Information Update: 12 Sep 2025

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At a glance

Originator Hanmi Pharmaceutical
Developer Assertio Therapeutics; Hanmi Pharmaceutical
Class Chemoprotectants; Granulocyte colony-stimulating factors; Immunoglobulin Fc fragments; Polyethylene glycols; Recombinant proteins
Mechanism of Action Granulocyte colony stimulating factor replacements; Granulocyte colony-stimulating factor receptor agonists

Orphan Drug Status

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

No
New Molecular Entity No

08 Sep 2025 Eflapegrastim licensed to Tabuk Pharmaceuticals in Middle East-North Africa (MENA) region
13 Dec 2024 Efficacy and safety data from a phase I trial in Neutropenia released by Assertio Therapeutics
10 Dec 2024 Efficacy and safety data from a phase I trial in Neutropenia presented at the 47^th Annual San Antonio Breast Cancer Symposium (SABCS-2024)

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