GX H9

Drug Profile

GX H9

Alternative Names: GX-H9; hGH-hyFc; HL 2356; Long-acting human growth hormone - Genexine; Somatropin long-acting - Genexine/Handok

Latest Information Update: 23 Nov 2016

Price : $50

At a glance

  • Originator Genexine
  • Developer Genexine; Handok Inc
  • Class Growth hormones; Hormonal replacements; Recombinant fusion proteins
  • Mechanism of Action Somatotropin receptor agonists
  • Orphan Drug Status

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

    Yes - Somatotropin deficiency
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Somatotropin deficiency

Most Recent Events

  • 16 Nov 2016 Handok and Genexine complete a phase I trial for Somatotropin deficiency in Netherlands before November 2016
  • 16 Nov 2016 GX H9 receives Orphan Drug status for Somatotropin deficiency (In adults, In children) in USA
  • 16 Oct 2015 GX H9 licensed to Tasly in China
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