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KDDF-201509-12 Global Phase 2 study in pediatric patients (PGHD) of next generation human growth hormone drug (GX-H9) and global License out(Metabolic Disorders, Protein) [2019-03-18]

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Ongoing Project
Section Lead
Generation
Lead
Optimization
Preclinical Phase I Phase II Phase III

Development and Market Objectives

-Genexine has a platform technology called “hybrid Fc (hyFc)” designed for the long-acting Fc fusion proteins by hybridizing IgD and IgG4
-Genexine’s hyFc growth hormone (GX-H9) has potential for differentiated best-in-class profile; safe and long-acting, without significant reduced efficacy
-Growth hormone market size is about $3.5 B in 2013 and expected to increase to $4.7 B by 2018 (Wall Street Journal 2014)

Unmet Medical Need & Target Patients

Unmet medical needs
-Much less pain due to less frequent injections using fine needle
-High level of compliance guaranteed due to less frequent injections
-High growth due to high level of compliance

Target patients
1.Pediatric growth hormone deficiency (PGHD): 
-Growth hormone secretary impairment or deficiency due to an abnormal pituitary gland
-Lowest 3% of common-age growth rate or growth less than 5cm per year (growth delay or dwarfism)
-Short stature, low growth velocity for age, increased fat around waist, younger look and delayed tooth development
2.Adult growth hormone deficiency (AGHD):
-Adult onset associated with pituitary damage by surgery, brain tumor, infections, injury or radiation therapy
-Childhood onset as a result of congenital, genetic, acquired or idiopathic causes
-Overweight, increased body & abdominal fat, skin thinning & dryness, reduced muscle mass, low energy and low mood

Status

On-going EU/KR Phase 2 study for growth hormone deficiency (GHD) patients in both adult and pediatric populations, and this is a Co-development project with Handok, Inc.

Intellectual Property

Issued: US, Korea, Japan, Canada, Singapore, Israel, Australia, Russia, EU
Filed or under review: China, Brazil, Hong Kong, India

Competitive Advantages

-Efficacy related dose response robustness
-Safe and long-acting technology
-Straight forward manufacturing process
-Best weekly and first semi-monthly
-Strong IP protection of hyFc technology

Contact & Company Overview

Related Project

Related Project
Global Phase 2 study (AGHD) of next generation human growth hormone drug (GX-H9) in EU/KR and Approval of PGHD trial in EU Project view
Conduct and Completion of a Global Clinical Phase I Trial of a Next-Generation Human Growth Hormone Product Project view
Global pre-clinical trial and CTA in the EU for a next generation long-acting human growth hormone Project view
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