Domestic COVID-19 Treatment to Accelerate Supply Next Month

MFDS "If an application is received, it will be processed promptly within 40 days"

[Image source=Yonhap News]

[Asia Economy Reporter Cho Hyun-ui] The Ministry of Food and Drug Safety is accelerating the review schedule to align the introduction of COVID-19 treatments with January next year. Since some time is needed to introduce vaccines, the intention is to urgently deploy treatments to calm the situation.

On the 14th, when asked whether COVID-19 treatments would be available in January next year, a Ministry of Food and Drug Safety official avoided a direct answer but responded, "If a treatment approval application is submitted, we will proceed as quickly as possible within 40 days." The official added, "Under the 'High-Intensity Rapid Product Promotion Program' currently in operation for the expedited approval of COVID-19 treatments and vaccines, the review period has been reduced from the existing 180 days to 40 days," and "We will start the review immediately upon receiving the approval application." Although the schedule has not been finalized, this means they intend to expedite related timelines so that treatments can be used in the field as soon as possible.

Celltrion Antibody Treatment Aims for Approval Application Within This Year

According to the pharmaceutical and bio industries, Celltrion is the furthest ahead in treatment development. Celltrion is currently deriving interim results from the Phase 2 clinical trial of its antibody treatment 'CT-P59.' A Celltrion official explained, "We cannot specify the exact application timing, but it is true that we aim to apply within this year." The previous day, Lee Nak-yeon, leader of the Democratic Party of Korea, mentioned, "We are striving to start treatment use before late January next year and vaccine administration before March," which is interpreted as considering Celltrion’s development schedule.

As Lee stated, for a domestically produced COVID-19 treatment to be commercialized as early as the beginning of next year, Celltrion must submit a conditional approval application by the 21st at the latest. The Ministry of Food and Drug Safety plans to conduct the review within 40 days, including holidays, so to receive approval by January 31, the conditional approval application should be submitted by early next week according to the schedule.

[Image source=Yonhap News]

Drug Repurposing Development Also Making Rapid Progress

GC Green Cross is also aiming to complete Phase 2 clinical trials of its plasma treatment 'GC5131A' within this year. GC Green Cross is currently conducting Phase 2 trials on 60 high-risk patients at 12 hospitals including Chung-Ang University Hospital and Samsung Seoul Hospital. Separately from clinical trials, GC5131A has received 21 approvals for treatment use. Treatment use approval is a system where the Ministry of Food and Drug Safety permits the use of investigational drugs for emergency patients whose lives are at risk or who have no alternative treatments. Recently, a man in his 70s diagnosed with COVID-19 was cured after receiving GC5131A.

Pharmaceutical companies developing COVID-19 treatments through 'drug repurposing' are also making rapid progress. Daewoong Pharmaceutical plans to develop its chronic pancreatitis treatment 'Hoistar Tablets' as an oral treatment for COVID-19 similar to 'Tamiflu.' Tamiflu is a treatment for novel influenza. A Daewoong Pharmaceutical official said, "We expect clinical results within this year and aim for (conditional) approval in January next year." Chong Kun Dang is also targeting to complete Phase 2 clinical trials of its pancreatitis treatment 'Napabeltan' within this year and to apply for conditional approval domestically in January next year. Bukwang Pharmaceutical, Shinpung Pharmaceutical, and Dong Wha Pharmaceutical are also conducting Phase 2 clinical trials.

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