'First Domestic COVID-19 Vaccine' Followed by Treatments... Being Developed by 19 Companies Including Ildong Pharmaceutical

10 Companies with New Candidate Substances Approved for Clinical Trials

Pfizer's oral COVID-19 treatment 'Paxlovid'
[Image source=Yonhap News]

[Asia Economy Reporter Lee Gwan-ju] As the birth of SK Bioscience's first domestically produced COVID-19 vaccine becomes visible, attention is focused on whether the next generation of domestic therapeutics can emerge. In the process of transitioning from a pandemic to an endemic, the localization of oral therapeutics is considered a major task.

According to the Ministry of Food and Drug Safety on the 27th, the COVID-19 therapeutics officially approved in Korea are Celltrion's 'Rekikona' and Gilead Sciences' 'Remdesivir.' Rekikona was successfully developed as the first domestic therapeutic, but its efficacy against the Omicron variant was found to be low, leading to a halt in new supplies. For oral therapeutics, Pfizer's 'Paxlovid' and Merck's 'Lagevrio' have received emergency approval and are being prescribed, but there are no approved domestic oral therapeutics yet.

Currently, 19 domestic companies are developing COVID-19 therapeutics. Among them, the most promising is 'S-217622,' jointly developed by Ildong Pharmaceutical and Japan's Shionogi Pharmaceutical. In Korea, clinical phase 2 and 3 patient dosing has been completed and data analysis is underway. In Japan, an emergency use approval application was submitted on the 22nd but the approval decision is scheduled for re-examination next month. It is expected that the Ministry of Food and Drug Safety will initiate the approval process for emergency use authorization next month in Korea as well.

In addition to Ildong Pharmaceutical, 10 domestic companies have received clinical approval to develop COVID-19 therapeutics with new candidate substances, including Genexine, Dong Wha Pharmaceutical, ImmunMed, Korea United Pharm, Telcon RF Pharmaceutical, GeneOne Life Science, Genencell, Shaperon, and BioLeaders.

Dong Wha Pharmaceutical's candidate substance 'DW2008S' was selected in March as a clinical support project by the COVID-19 Therapeutics and Vaccine New Drug Development Project Group and is conducting phase 2 clinical trials with support from the Ministry of Health and Welfare. Genencell began patient dosing for phase 2 and 3 clinical trials last month with the natural product-derived candidate substance 'ES16001.' Additionally, CrystalGenomics, Shinpoong Pharmaceutical, and Hyundai Bioscience are developing COVID-19 therapeutics through drug repositioning methods.