Ildong-Shionogi Oral COVID-19 Treatment, Launch Imminent

'Jokoba' Trademark Patent Application Completed
Fewer Contraindicated Drugs and Improved Medication Convenience

Domestic Clinical Trials Gain Momentum... Possible Launch in Second Half of Year
Price Expected to Be About Half of Paxlovid

[Asia Economy Reporter Chunhee Lee] The oral COVID-19 treatment 'S-217622,' jointly developed by Ildong Pharmaceutical and Japan's Shionogi Pharmaceutical, is entering its final stages before launch.

According to industry sources on the 18th, Shionogi Pharmaceutical's trademark patent application for 'Jokoba (XOCOVA)' filed with the Korean Intellectual Property Office is nearing completion. Jokoba has been used as the Japanese brand name since the early development of S-217622. Alongside this, trademarks such as Jokobea (ZOKOVEA), Jokobaty (XOCOVATY), Jovished (XOVISHED), Jokovetti (XOCOVETTI), and Vyveclis (VYVECLIS) have also been filed. While Ildong Pharmaceutical is likely to hold the domestic distribution rights, the trademark rights belong to Shionogi, indicating that Shionogi has registered the domestic trademark rights as well.

According to previously released Phase 2b clinical trial results of S-217622, the treatment group showed nearly a 90% reduction in the rate of positive virus detection compared to the placebo group on the fourth day of treatment. The virus shedding period was also confirmed to be reduced by about 1 to 2 days compared to the control group.

S-217622 works by inhibiting the coronavirus-specific protease enzyme '3CL-protease,' thereby blocking viral replication. This mechanism is similar to Pfizer's 'Paxlovid.' Because it targets the enzyme rather than the spike protein where coronavirus mutations concentrate, it can suppress the virus regardless of mutations.

It also offers high medication convenience. Paxlovid and MSD's (Merck & Co., USA) 'Lagevrio' require taking 3 pills twice daily for 5 days (total 30 pills) and 4 pills daily for 5 days (total 40 pills), respectively. In contrast, S-217622 is currently undergoing clinical trials with a once-daily dosing regimen for 5 days. Additionally, it is expected to have significantly fewer contraindicated drug interactions, which have been a major obstacle to expanding prescriptions of existing drugs.

Domestic clinical trials are also gaining momentum. Ildong Pharmaceutical is currently recruiting 200 participants in Korea for Phase 2b and Phase 3 clinical trials. An Ildong Pharmaceutical official explained, "Participant recruitment is nearly complete." Furthermore, combined with global clinical trials conducted by Shionogi Pharmaceutical in Japan and other countries, a large-scale trial involving approximately 2,000 participants is expected.

The domestic launch is highly likely to occur in the second half of the year. This is because the two companies are pursuing a strategy to first obtain approval in Japan and then use that as a stepping stone for domestic approval. Initially, Japan's conditional approval system had a loophole that applied only when importing drugs already used overseas, but recently, the Japanese parliament passed an amendment to the 'Medical Device Act' allowing use if efficacy is estimated during the interim stage of clinical trials, which is expected to accelerate approval within Japan.

If the launch is realized, although it cannot be considered a purely domestic treatment due to joint development, it is significant that a Korean pharmaceutical company participated in development and production will take place domestically. Ildong Pharmaceutical plans to manufacture S-217622 at its Anseong plant in Korea. Price competitiveness is also expected to improve significantly compared to existing treatments. While Pfizer's Paxlovid currently sells for about $500 per person, S-217622 is predicted to be priced at about half that amount.