[Exclusive] Celltrion to Apply for COVID-19 Antibody Treatment Approval Tomorrow... Market Launch Next Month (Comprehensive)

CT-P59, Possible Launch in January Next Year
Functions as Both Treatment and Vaccine

Seo Jung-jin, Chairman of Celltrion Group

[Asia Economy Reporters Kwangho Lee and Hyunui Cho] Celltrion announced on the 29th that it will apply for conditional approval of its novel coronavirus disease (COVID-19) antibody treatment 'CT-P59.' If health authorities grant approval, this will become the first domestically produced COVID-19 treatment. The treatment is expected to be actively used for therapy as early as the end of January next year.

A senior government official stated on the 28th, "We understand that Celltrion will apply for conditional approval of CT-P59 to the Ministry of Food and Drug Safety (MFDS) tomorrow." The Phase 2 clinical trial results submitted by Celltrion to the MFDS for conditional approval reportedly demonstrate safety and efficacy. Celltrion completed Phase 2 dosing on the 25th of last month and has been analyzing related data for about a month.

The government is expected to expedite the approval process as much as possible, considering the recent surge in COVID-19 cases, the domestic influx of the UK variant virus, and vaccine supply conditions. Another government official said, "Once the approval application is received, the MFDS will review it for about four weeks before deciding whether to approve it."

Although the review period for COVID-19 treatments and vaccines was recently shortened drastically from 180 days to 40 days, there is a possibility of an even faster process. Lee Nak-yeon, leader of the Democratic Party of Korea, recently said, "Within a few days, the MFDS will receive the conditional use approval application for the domestic treatment, and the next steps will proceed," adding, "We will advance treatment and vaccination by confirming safety and efficacy." This statement is interpreted as reflecting the anticipated schedule.

Likely Market Release in January Next Year... Also Serving as a Vaccine

Celltrion's antibody treatment 'CT-P59'
[Image source=Yonhap News]

According to the government official, if health authorities conduct the review and approval process over four weeks including holidays, CT-P59 could be released as early as the end of January next year. Celltrion has produced enough supply since September to treat 100,000 domestic patients, ready for immediate use in medical settings once conditional approval is granted. The government official said, "If the MFDS approves without major issues, it could be marketed as early as the end of January next year."

Celltrion's antibody treatment targets patients with mild symptoms. The core goal is to prevent organ damage, which is a primary factor leading to severe illness, through early diagnosis and early treatment. A Celltrion official explained, "The COVID-19 virus reaches its peak viral load about one week after infection," adding, "It is important to administer the antibody treatment quickly during this period."

For this reason, it could serve as a solution to the COVID-19 vaccine supply shortage. CT-P59 can function not only as a treatment but also as a vaccine. Kiwon Kwon, Head of Research and Development at Celltrion, explained, "It not only immediately neutralizes the virus in infected patients but also, when administered to healthy individuals, can block incoming viruses from outside for about 2 to 3 weeks, which is the antibody half-life."

Fierce Competition for the 'Second' Title

Even if Celltrion's antibody treatment becomes the first domestically produced COVID-19 treatment, competition for the 'second' title is expected to be fierce. GC Green Cross aims to complete Phase 2 clinical trials of its plasma treatment 'GC5131A' by February next year. Results are expected around April next year, but interim results will be announced soon.

Domestic pharmaceutical companies developing COVID-19 treatments through 'drug repositioning' are also entering the final countdown for next year's release. Daewoong Pharmaceutical is developing 'Hoistar Tablets,' a chronic pancreatitis treatment, as an oral treatment for COVID-19 similar to Tamiflu. Daewoong Pharmaceutical has received combined approval for Phase 2/3 clinical trials of Hoistar Tablets and is currently collecting data from 1,000 mild patients. A Daewoong Pharmaceutical official stated, "We plan to secure Phase 3 clinical trial results within the first half of next year." Chong Kun Dang is also preparing to announce Phase 2 clinical trial results. Chong Kun Dang plans to complete Russian clinical trials of 'Napabeltan,' a pancreatitis treatment being developed as a COVID-19 treatment, within this year and apply for conditional approval domestically in January next year.

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