How Far Has the Domestic No.1 Oral COVID-19 Treatment Progressed?

5 New Material Development Companies and 6 Drug Repurposing Firms
Most Are in Phase 2 or 3 Trials, but Some Have Withdrawn

[Image source=Yonhap News]

[Asia Economy Reporter Kim Young-won] As the first domestically produced COVID-19 vaccine enters the approval process in South Korea, attention is also turning to domestic companies developing oral treatments. On the 29th of last month, SK Bioscience applied for approval of its self-developed SKYCovione Multi (GBP510) to the Ministry of Food and Drug Safety, bringing the first domestic COVID-19 vaccine closer than ever.

According to industry sources on the 3rd, among the oral treatments approved so far, none are products of domestic companies. Both Paxlovid and Lagevrio are products of American pharmaceutical companies Pfizer and Merck, respectively. Celltrion's injectable antibody treatment 'Rekkironah' is the only domestic COVID-19 treatment, but the health authorities halted new supplies from February 28th due to evidence that Rekkironah's effectiveness against the Omicron variant is reduced.

Oral treatments are expected to be used more broadly than antibody treatments. The government plans to secure sufficient COVID-19 treatments and expand prescriptions considering high-risk groups and potential re-outbreaks in the post-Omicron period. Additionally, oral treatments are included in the 'high-risk group fast track,' which links testing, prescription, and home treatment, so demand is expected to continue.

Currently, at least 11 domestic companies are developing oral treatments. Among them, five companies?Dong Wha Pharm, GeneOne Life Science, Genencell, Ildong Pharmaceutical, and BioLeaders?are developing new candidate substances. Six companies aiming to become the first domestic oral treatment through drug repurposing are CrystalGenomics, Daewoong Pharmaceutical, Shinpoong Pharmaceutical, Amicogen Pharma, Daewon Pharmaceutical, and Hyundai Bioscience.

The most promising candidate for the first domestic oral treatment is 'S-217622,' jointly developed by Ildong Pharmaceutical and Japan's Shionogi Pharmaceutical. Clinical Phase 2b and 3 trials are currently underway in South Korea targeting asymptomatic, mild, and moderate patients. Research results have shown effectiveness against the Omicron variant, and a supply contract for one million doses has been signed with the Japanese government. Dong Wha Pharm'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. Dong Wha Pharm will proceed with Phase 2 clinical trials with support from the Ministry of Health and Welfare.

Most other companies are also in Phase 2 or higher clinical stages. Genencell began recruiting patients for Phase 2 and 3 trials of 'ES16001' from the 29th of last month. Daewoong Pharmaceutical received approval to plan Phase 3 trials of 'DWJ1248 (Camostat)' targeting severe patients.

Some companies have discontinued treatment development at the Phase 2 clinical trial level. Bukwang Pharmaceutical halted development after Phase 2 clinical trial results of 'CLV-203' in mild to moderate COVID-19 patients failed to demonstrate significant treatment effects compared to placebo in the primary endpoints. The changing COVID-19 situation is also a variable. Daewoong Pharmaceutical has suspended Phase 2 and 3 trials of Camostat targeting mild to moderate patients. Daewoong Pharmaceutical explained the reason for suspension, stating, "As the Omicron variant became dominant and the severity rate of COVID-19 sharply declined, and confirmed patients recovered quickly, the medical importance of developing treatments for mild cases decreased."