Market Overview

Alteogen Gets FDA Approval for Orphan Drug Designation with an Antibody-Drug Conjugate for Gastric Cancer


(KOSDAQ: 196170) announced that it has successfully got an
approval for orphan drug designation from the US Food and Drug
Administration (FDA) with one of its assets (ALT-P7) for gastric cancer
(designation letter 18-6439) last week. ALT-P7 is an antibody-drug
conjugate (ADC) using a Trastuzumab variant form of antibody, and this
approval would guarantee Alteogen the market exclusivity rights for
seven years after FDA's approval of ALT-P7 for gastric cancer treatment.

The FDA designation of orphan drug is designed to support the
development and approval of drugs for the treatment of rare diseases or
life-threatening illnesses. Products designated as orphan drugs would be
recognized for not only market exclusivity after FDA approval, but also
get additional benefits, such as tax benefit of the total costs for
clinical trial studies, scientific advice meetings with FDA during the
development process, and waiver of marketing application user fees.

ALT-P7, a candidate ADC treatment drug for gastric and breast cancers,
is an anti-cancer ADC utilizing the company's unique "NexMabTM"
platform technology, a proprietary next-generation site-specific
conjugation methodology developed by the company. The related patents
are registered in seven countries so far.

ALT-P7 is currently undergoing a first-in-human phase 1 clinical trial
for breast cancer patients in Korea, after the investigational new drug
(IND) approval last year from the Ministry of Food and Drug Safety
(MFDS) of Korea (NCT03281824). Alteogen is planning to start phase 2
clinical trial for breast cancer patients in 2019. Following the current
breast cancer trial, Alteogen will extend the clinical development of
ALT-P7 for gastric cancer as well, which already has proven efficacy in
pre-clinical in vitro and in vivo studies.

"The orphan drug designation of ALT-P7 by the US FDA will accelerate the
advancement of gastric cancer treatment in the US," said Dr. Soon Jae
Park, Ph.D., CEO of Alteogen. "We believe that ALT-P7 can provide a
breakthrough in the treatment of Her-2 overexpressing gastric cancer,
for which there is no effective target treatment yet".

About Alteogen Inc.

Alteogen lnc. is a Korea-based biopharmaceutical company that focuses on
the development and commercialization of novel biologics such as ADCs,
biobetters and biosimilars. Alteogen's portfolio includes clinical-stage
long-acting therapeutic proteins and next-generation ADCs, developed by
its proprietary NexPTM-fusion and NexMabTM ADC
conjugation technologies, respectively. It also develops Herceptin and
Eylea biosimilars. The company was founded in 2008 and listed in KOSDAQ
(196170.KQ). Further Information, please visit:

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