SEOUL, May 11 (Korea Bizwire) – Korean pharmaceutical and biotech companies are rushing to conduct Phase I clinical trials.
Phase 1 trials are the first step in human testing of new drugs, and they’re the first step in new drug development.
According to the Ministry of Food and Drug Safety, a total of 64 Phase 1 trials have been approved this year. This includes domestic pharmaceutical and biotech companies as well as contract research organizations (CRO). The 64 approved trials mark an increase of 25 percent compared to the same period last year.
Anterogen, KangStem Biotech, and CHA Biotech, three companies specializing in stem cell medication, were among those receiving approval for clinical trials.
Anterogen will be conducting follow-up trials on patients that were drug-tested for dose-ranging. KangStem will also conduct follow-up trials on patients who were tested with Furestem-RA, a treatment for rheumatoid arthritis. CHA Biotech was approved for Phase 1 clinical trials of CB-AC-02, a medication for degenerative disc disease.
Some companies are preparing to launch overseas clinical trials.
Dong-A Pharmaceutical is planning an overseas clinical trial of its antidiabetic (DA-1241), as well as DA-8010, a medication for overactive bladder syndrome. ChongKunDang Pharmaceutical is arranging overseas trials for its CKD-504, a medication for Huntington’s disease.
“The fact that there are more Phase I clinical trials implies that pharmaceutical and biotech companies are placing emphasis on research and development,” said a pharmaceutical official. “But Phase I is still a long way from the actual approval of a new drug, so there’s no need for much excitement yet.”
By Lina Jang (firstname.lastname@example.org)