What’s the Next Step for Ildong’s 'Jokoba' After Emergency Use Authorization Fails?

Ildong Pharmaceutical Holding Domestic Distribution Rights
Likely to Proceed with Approval Process

Oral COVID-19 treatment 'Zokoba' jointly developed by Japan's Shionogi Pharmaceutical and Ildong Pharmaceutical [Image source=Reuters Yonhap News]

[Asia Economy Reporter Chunhee Lee] Ildong Pharmaceutical's oral COVID-19 treatment 'Zokova' (active ingredient: Ensitrelvir Fumarate), jointly developed with Japan's Shionogi Pharmaceutical, has been denied domestic Emergency Use Authorization (EUA).

On the 28th briefing, the Central Disease Control Headquarters of the Ministry of Health and Welfare stated regarding Zokova, "Following the review and resolution by the Infectious Disease Control Committee, it was decided that the request for EUA from the Ministry of Food and Drug Safety and the government's need to purchase Zokova are low." Im Suk-young, the Situation General Manager of the Central Disease Control Headquarters, explained, "After discussions with related ministries and clinical advisory input, the Infectious Disease Control Committee made the final review and resolution," adding, "This decision was based on a multifaceted review of Zokova's clinical efficacy, safety, drug information, overseas EUA status, and purchase trends."

Zokova is an oral antiviral taken once daily (three times on the first day) for five days. It selectively inhibits the viral protein-degrading enzyme 3CL-protease, which is necessary for the replication of the COVID-19 virus, thereby preventing viral proliferation. In phase 3 clinical trials conducted in Korea, Japan, and Vietnam, Zokova showed an effect of shortening the time to symptom resolution by more than 24 hours compared to the placebo group?167.9 hours versus 192.2 hours?for five characteristic symptoms of the Omicron COVID-19 variant: fever, cough, sore throat, runny nose and nasal congestion, and fatigue.

Currently, after three attempts last month, Zokova received EUA in Japan, and related procedures are under review in the United States and Europe. Domestically, Ildong Pharmaceutical secured the Korean distribution rights from Ping An Shionogi, a joint venture between Shionogi and China's Ping An Insurance, which holds the Asian rights for Zokova. Ildong Pharmaceutical had planned to produce the first domestically made oral COVID-19 treatment after obtaining domestic approval, but the EUA denial has delayed these plans.

Regarding post-approval utilization, the Disease Control Agency's budget for next year includes 384.3 billion KRW for purchasing treatments: 400,000 courses of oral treatments and 18,000 courses of injectable treatments. Most of the oral treatment budget is expected to be used for previously contracted supplies such as MSD (Merck, USA)'s Molnupiravir and Pfizer's Paxlovid, leaving little room for Zokova.

Ildong Pharmaceutical Headquarters Building Exterior (Photo by Ildong Pharmaceutical)

However, the government stated it will "continuously monitor overseas EUA approvals, subsequent clinical results, purchase, and utilization status," indicating that the denial of EUA does not completely rule out Zokova's domestic introduction. Since EUA is a system that expedites the introduction process when the urgency of bringing a drug into the country is high, it is difficult to interpret the government's stance as negative toward Zokova's efficacy itself.

Ildong Pharmaceutical is expected to continue the approval process for Zokova through conditional approval or full approval. As the winter cold continues and COVID-19 resurgence intensifies, the need for Zokova may increase, and related responses are reportedly being prepared.

This content was produced with the assistance of AI translation services.