Benegrastim - Generon (Shanghai) Corporation

Drug Profile

Benegrastim - Generon (Shanghai) Corporation

Alternative Names: Bineuta; F-627; rh G-CSF Fc Fusion Protein

Latest Information Update: 16 Mar 2018

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At a glance

  • Originator Generon (Shanghai) Corporation
  • Class Chemoprotectants; Granulocyte colony-stimulating factors; Recombinant fusion proteins
  • Mechanism of Action 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 Yes
  • Available For Licensing Yes

Highest Development Phases

  • Phase III Neutropenia

Most Recent Events

  • 24 Jan 2018 Efficacy data from a phase III trial in Neutropenia released by Generon Corporation
  • 20 Dec 2017 Generon Corporation completes a phase-III clinical trial in Neutropenia (Chemotherapy-induced, In adults, In the elderly) in USA and Hungary (SC) (NCT02872103) (EudraCT2016-001930-93)
  • 10 Oct 2017 US FDA accepts phase III trial design of Benegrastim under Special Protocol Assessment for Neutropenia (Chemotherapy-induced)
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