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. |