News

TitleUS FDA NDIN approval for 'Deglusterol', a new dietary ingredient for blood sugar control2022-03-23 17:56
Name Level 10



Dear Global partners and shareholders

We are pleased to inform you that our new dietary ingredient for glucose control, 'Deglusterol',
has been approved by the US Food and Drug Administration (FDA) as a 'New Dietary Ingredient (NDI)' on March 21st.
The NDI certification is a system in which the safety and effectiveness of the ingredients are verified by the US FDA
and certified as a NDI. This is the world's first case of NDI with synthetic functional peptides.

With this achievement of the NDIN certification by the US FDA, the registration in many countries around the world
such as Europe (EU), UK, China, Japan, India, Russia, Mexico, Brazil, Saudi Arabia, Indonesia, etc., will be made faster and easier.

Deglusterol is a neutraceutical product that can immediately experience the effect of reducing blood sugar,
and it will revolutionize the global functional food market for healthy blood sugar and become an innovative product that
can elevate the status of K-BIO.

Caregen’s Hwaseong Peptide Synthesis Plant, completed in 2021, plans to mass-produce of the peptides including Deglusterol,
and within the first half of this year, it is expected that commercial products as a drink and powder product (taken once a day)
will be launched under 'proGsterol' brand and It will contribute to sales from Q3. 

This NDIN approval is a great achievement in recognition of the functionality and safety of synthetic peptides as ingredients
for healthy functional foods that we have been preparing for a long time..

In addition to Deglusterol, we are planning to conduct a clinical trial this year to register our new muscle-strengthening peptide
that can improve muscle loss by aging as NDIN

We are continuously developing new peptides for various indications, and we will also increase the value of the peptide platform
by detailed execution plans for the healthy functional food and pharmaceutical business.

 

Yongji Chung, Ph D.

Chief Executive Officer and Chief Technology Officer
Caregen Co., Ltd.