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COMPANY

History

Here are the footsteps that CorestemChemon has taken

2020’s

2023

In Feb
NeuroNata-R clinical Phase 3 patient registration completed.

2022

In Dec
Non-clinical CRO ChemOn merged and renamed to CorestemChemon.
In Nov
Mutual Visit Evaluation by OECD.
In July
GLP certification (MFDS) for safety pharmacology (Nav 1.5, Cav 1.2, MEA).

2021

In Aug
Designation as a testing institution for veterinary medicines and others (QIA).
In Apri
NeuroNata-R initiated Phase 3 and administered the first patient.

2020

In Nov
Expanded Access Program (EAP) authorization from the US FDA.
In Aug
Approval granted for the amendment of NeuroNata-R's Phase 3 clinical trial plan by the Ministry of Food and Drug Safety.
In July
US FDA approved NeuroNata-Alju's Phase 3 clinical trial plan.
In Feb
Application submitted for NeuroNata-R's Phase 3 clinical trial plan to the US FDA.
2010’s

2019

In Dec
Accumulated 300 patients treated with NeuroNata-R.
In Mar
NeuroNata-R designated as an orphan drug by the European Medicines Agency (EMA).
In Jan
Designation as a testing institution for non-clinical trials of medical devices and certification for alternative toxicity testing (MFDS).

2018

In Sep
Designation as a testing institution for environmental toxicity (NIER) and GLP certification for skin sensitization testing (NIER).
In Aug
NeuroNata-R designated as an orphan drug by the US FDA.
In July
Publication of NeuroNata-R's Phase 2 clinical study in Annals of Neurology.
In May
Authorization for the use of radiation-emitting devices issued by the Nuclear Safety and Security Commission for CRO.

2016

In Mar
Certification (MFDS) for cardiovascular safety pharmacology (in vitro hERG) and other tests(MFDS).

2015

In June
Listing on the KOSDAQ market and commencement of trading.

2014

In July
Approval granted for the manufacturing and sale of NeuroNata-R.

2013

In Nov
Designation as an excellent animal testing facility (MFDS).
In Sep
Acquisition of shares in ChemOn (non-clinical CRO) by Corestem.
In Aug
Completion of Phase 2 clinical study for NeuroNata-R.

2012

In Dec
Certification (MFDS) for central nervous system and respiratory system safety pharmacology.

2011

In Nov
Completion of Phase 1 clinical study for NeuroNata-R.

2010

In Oct
Approval for AAALAC Full Certification.
2000’s

2008

In Oct
Designation as a research institute for pesticide safety testing (RDA).
In Sep
Designation as a research institute for hazardous substance testing (NIER).

2007

In Mar
received certification as a technology-innovative small and medium-sized enterprise (SME) from the Small and Medium Business Administration.

2006

In Mar
GLP certification (MFDS) for carcinogenicity testing.

2003

In Dec
Establishment of CoaStem.
In Feb
GLP certification (MFDS) for repeated dose toxicity, reproductive toxicity, immunotoxicity, and local toxicity.

2002

In Aug
GLP certification (MFDS) for single dose toxicity and genotoxicity.

2000

In Jan
Certification of ChemOn's establishment and corporate-affiliated research institute.