Daewoong Pharmaceutical received approvals for eight phase 3 clinical trials last year, beating all other Korean companies, according to a Ministry of Food and Drug Safety website.
Phase 3 clinical trials that won the regulator’s nod in 2020 included those on the additional studies on its Covid-19 treatment (DWJ1248), diabetes treatment (DWP16001), gastroesophageal reflux disease treatment (DWP14012), and a botulinum toxin product to treat square jaw.
Hanmi Pharmaceutical came next with three approvals, followed by two for Samsung Bioepis, Celltrion, Ahngook Pharmaceutical, and Daewon Pharmaceutical.
Industry watchers attributed the relatively brisk applications for phase 3 clinical trials by local pharmaceutical firms to their research and development efforts despite the outbreak of the Covid-19 pandemic.
According to a Financial Supervisory Service report, seven of the top 10 Korean pharmaceutical companies increased their R&D spending in the third quarter of last year from a year ago. The cumulative R&D spending by top-10 drugmakers in the third quarter totaled 7.1 trillion won ($6.5 billion), up 10 percent from the same period of 2019.
Five of the top-10 companies -- Hanmi, Daewoong, Ildong Pharmaceutical, Dong-A ST, and Yuhan Corporation -- increased their R&D expense rate by more than 10 percent.
“Although the total R&D investment by local pharmaceutical companies is meager compared to those of multinational companies, the conduct of an increasing number of phase 3 clinical trials shows that the active R&D investment is working,” said Lee Jun-soo, an analyst for Prophet Asset Management.
Lee stressed that local pharmaceutical companies should continue to increase R&D expenditure to keep up the momentum.
“Of course, in 2020, there are companies that reduced R&D investment due to the Covid-19 epidemic,” Lee said. “However, more companies tried to secure future growth engines by expanding investments at the risk of a short-term setback in profitability.”
Lee added that it is a good sign as the local drug industry is shifting toward developing new drugs through R&D and breaking away from existing generic-oriented sales.
Among multinational pharmaceutical companies, MSD Korea won the highest number of approvals for phase 3 clinical trials with 12 cases, followed by Roche Korea (11), AstraZeneca Korea (10), Novartis Korea (9), Janssen Korea (8), Gilead Science Korea (6), AbbVie Korea and Sanofi-Aventis (5), Lilly Korea (4), Bayer Korea, Celgene, and BMS Korea (2), and GSK Korea (1).
Most of the clinical trials conducted by multinational pharmaceutical companies in Korea concerned anticancer treatments. Some companies, such as Gilead Science and Lilly Korea, focused on trials regarding the Covid-19 treatments.