`GX-H9`, an extended duration growth hormone jointly under development
by Handok and Genexine receives Orphan Drug Designation by the US FDA for the
treatment of growth hormone deficiency

‘GX-H9’, an extended duration growth
hormone product which is being jointly developed by Handok (Chairman Youngjin Kim) and Genexine (CEO Hansoo Kyung) has been
selected as an orphan drug for the treatment for growth hormone deficiency
disease from the US FDA on 9^th of November.

Growth hormone is a protein based
medicinal product, used widely for conditions such as growth retardation and
developmental disability of children due to lack of growth hormone and hormone
therapy for prevention of metabolic diseases and promotion of anti-aging
effects in adults. ‘GX-H9’ is an innovative new generation extended duration
growth hormone which applies Hybrid Fc technology, a technique exclusive to
Genexine. It enables a once weekly or bi-weekly dosing of growth hormone, as
opposed to daily dosing required for other existing formulations.

Growth hormone deficiency is a rare and
intractable disease where secretion of growth hormone is deficient, due to
factors such as damage in pituitary gland, genetic deficiencies and tumor in
pituitary gland or hypothalamus. Such lack of growth hormone may lead to a
reduction in muscle and bone mass and increase in serum cholesterol
concentration in adults. For children, lack of growth hormone manifests as
dwarfism, growth retardation and delayed sexual development, causing a
significant deterioration in quality of life.

Orphan Drug Designation by FDA is a
policy which allows benefits and advantages to the company that’s developing
medication for diseases which are rare and intractable, or which threats
survival to accelerate development of such medications. Under such scheme, ‘GX-H9’,
a growth hormone product with an extended duration, now qualifies for a priority
consideration in review for clinical trials, tax reductions for research funds
and licensing costs as well as 7 years of monopoly rights, preventing other
competitor products from entering the market.

Youngjin Kim, chairman of Handok mentioned
that he’s happy about the fact that they can accelerate the development of
their extended duration growth hormone product through this orphan drug
designation. He added that “By active cooperation with with Genexine, I hope we
could quicken the delivery of not only this product but also other innovative
bio medications to many patients suffering from rare and intractable diseases
in the world. We are hopeful that these medications will improve thir quality
of life”.

Meanwhile, since forming contract for
joint development and technical transfer associated with this extended duration
growth hormone product in June, 2012, Handok and Genexine will continue to
cooperate as strategic partners and divide all profit that comes from the
product in half. In addition, Handok became the biggest stock holder for
Genexine in 2014. The final outcome of phase 2 clinical trial for ‘GX-H9’, targeting adult
patients, is expected to be available at the end of this year, whereas the
outcome of phase 2 clinical trial for child patients is expected in the first
half of 2017.