Genexine Granted FDA Orphan Drug Designation for GX-H9 in Growth Hormone Deficiency

SEONGNAM, South Korea–(BUSINESS WIRE)– Genexine
(KOSDAQ: 095700), an innovative biotechnology company focused on
immuno-oncology, metabolic and orphan diseases, announced today that US
FDA Office of Orphan Products Development (OOPD) has granted GX-H9 an
orphan drug designation for the treatment of growth hormone deficiency.

GX-H9
is next-generation, long-acting recombinant human growth hormone (rhGH)
consisting of recombinant growth hormone genetically fused to Genexine’s
proprietary hybrid
Fc (hyFc) platform, giving it extended half-life and potentially
better safety profile. Compared to the current daily injection therapy,
GX-H9 is being evaluated as weekly and twice-monthly dosing regimens to
treat Growth
Hormone Deficiency (GHD).

The US FDA’s Orphan Drug Designation is a program devised to advance the
evaluation and expedite development of drugs and biologics which
demonstrate significant promises for the diagnosis or treatment of rare
diseases or life-threatening conditions affecting fewer than 200,000
people in United States. The designation provides the sponsor with
development and commercial supports such as prioritized FDA review on
clinical trials and approvals, credits on clinical trials, exemption
from certain regulatory fees and 7 years of market exclusivity.

“We are thrilled to announce the first FDA Orphan designation of our
pipeline. The Orphan Drug Designation for GX-H9 will enable us to move
one step faster towards our goal of providing convenience to adults and
kids suffering from GHD, especially in the largest GH market of the US,”
stated Dr. Michael Keyoung, President and Chief Executive Officer of
Genexine.

Genexine
presented its multinational Phase 2 interim data from both pediatric and
adult GHD
trials at The European Society for Paediatric Endocrinology’s 55th
Annual Meeting 2016 (ESPE) in September and will present at The 9th
Biennial Asia Pacific Pediatric Endocrinology Society/50th Annual
Japanese Society for Pediatric Endocrine Society Conference in Tokyo on
November 19th. Genexine will obtain full data from AGHD trial by the end
of this year and interim primary endpoint data from PGHD trial in 1H,
2017.

About Genexine

Genexine,
Inc. is a leading biotherapeutics company focused on immuno-oncology
and metabolic/autoimmune diseases. Genexine has robust pipelines in
clinical and pre-clinical stages based on long-acting Fc fusion
technology and therapeutic DNA technology. In the clinical stage,
Genexine has GX-H9 (long-acting human growth hormone, hGH-hyFc) for both
adult and pediatric growth hormone deficiencies, currently in
multinational phase II trials after the completion of an EU Phase I
study in strategic partnership with Handok. GX-188E therapeutic DNA
vaccine for HPV-associated diseases is in Phase II in Europe and Korea
for Cervical Intraepithelial Neoplasia II/III and plans to enter into
Phase 1b/2a trial in cervical cancer with GX-188E in combination
Keytruda (anti- PD-1 therapy) of Merck (also known as MSD) 1H of 2017.
Founded in 1999, Genexine has over 150 employees and half of them are
scientists with MSc or Ph.D. Genexine is located in Pangyo Techno Valley
near Seoul, Korea with a branch office in New York. Genexine has been
listed on KOSDAQ (095700) since 2009.

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