Local drugmaker Chong Kun Dang won approval for clinical trials the most among pharmaceutical firms and medical institutions last year, government data showed.
According to data from the Ministry of Food and Drug Safety, Chong Kun Dang won the regulatory nod for 25 clinical trial plans, followed by Seoul National University Hospital with 24, Novartis Korea with 22, Samsung Medical Center with 21, and MSD Korea with 20.
The top 20 firms with the most approved clinical trials included three domestic firms -- Chong Kun Dang with 25, Hanmi Pharmaceutical with 14, and CJ HealthCare with 11. Among the 17 multinationals were Novartis Korea with 22, MSD Korea with 20, AstraZeneca with 19, Janssen Korea with 15, Roche Korea with 13, Pfizer Korea with 13, AbbVie Korea with 11, and Lilly Korea with 10.
Among medical institutions, the four largest hospitals received approval for trials the most. The four are Seoul National University Hospital with 24, Samsung Medical Center with 21, Severance Hospital with 17, and Asan Medical Center with 14. The rest were contract research organizations (CRO).
Among CROs, Covance Korea ranked first with 15 approved clinical trials, followed by PPD Development with 15, Parexel Korea with 13, ICON Clinical Research with 10, and Quintiles with 10.
In 2018, the food and drug safety ministry gave the green light for 679 clinical trials, up 3.2 percent from 658 in 2017. Among them, 505 or 74.4 percent were conducted by pharmaceutical companies for the development of medicines. The rest 174, or 25.6 percent, were for academic purposes.
The most notable aspect in last year’s clinical trials was a rapid increase in early-stage studies. The number of approvals for phase-1 trials surged to 211 in 2018 from 176 in 2017.
The government approved 161 local phase-1 studies and 39 of them, or 24.2 percent, aimed at developing a new drug. Out of 39 studies, 37 or 94.9 percent were led by domestic companies.
“The high proportion of local firms in phase-1 studies signals that Korean companies are actively developing new medicines in the early stage with improved capabilities for new drug development,” the ministry said.
By types of efficacy, the ministry authorized 247 trials for anticancer drugs, 67 for endocrine system treatments, 54 for digestive system drugs, and 49 for cardiovascular therapies. Anticancer drug tests accounted for 36.4 percent of the total trials last year, maintaining the highest proportion for three consecutive years.
Another noteworthy aspect was that pharmaceutical firms were increasingly working on treatments for rare diseases.
A rare disease refers to a disease that affects fewer than 20,000 people in Korea or one without proper treatment and medication, determined and notified by the health and welfare minister.
There were only seven studies of Crohn’s disease, an inflammatory bowel disease, in 2016. However, the number rose to 15 in 2018.
There was only one clinical trial for hemophilia, a rare disease, in 2017 but the number of approved tests went up to six in 2018.
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