Local biologics company Celltrion on Tuesday filed for approval of its COVID-19 antibody treatment for use here, in what Seoul officials hope will be a new weapon in the country’s war against the new coronavirus in the absence of vaccines.
The Drug Ministry said it will attempt to review the safety and efficacy of the proposed COVID-19 treatment in the next 40 days.
If approved, the drug is anticipated to be ready for use in February in Korea.
Celltrion plans to submit similar applications in the US and Europe in January.
Celltrion’s CT-P59, or regdanvimab, is a neutralizing monoclonal antibody made with recombinant protein. It is differentiated from the previously used COVID-19 treatment remdesivir. Remdesivir inhibits the multiplication of the SARS-CoV-2 virus within human cells, while regdanvimab offers itself to bind with the coronavirus’s spike, by which it prevents the virus from entering the human cell in the first place.
Regdanvimab can help mild coronavirus patients to recuperate before their symptoms grow severe. Nationwide hope is staked on this drug to lift lethality off the pandemic.
Neither Celltrion nor the Drug Ministry has announced the analysis from global clinical phase 2 trials of regdanvimab as of yet. However, according to Celltrion Vice Chairman Kee Woo-sung, regdanvimab’s efficacy includes coronavirus variants. Kee spoke at a bio conference held in Seoul on Monday.
The same day Kee expressed optimism for CT-P59, Korea’s Drug Ministry rolled out a radical reduction of its COVID-19 treatment review process, from the conventional 150 days to under 40 days.
On this expedited course, Celltrion’s treatment may be out in the Korean market in February -- or even January if the pandemic situation grows grim.
The phase 2 trial is the first leg of the phase 2/3 trials conducted globally with 327 people scattered across Korea, Romania, the US, the UK and Spain.
Of the 327, 40 were in Korea.
This phase 2 trial had aimed to shorten the time it takes for a confirmed patient displaying seven COVID-19 symptoms from testing positive to testing negative. The seven symptoms are fever, cough, breathing difficulty, sore throat, muscle pain, tiredness and headaches.
Celltrion will continue to carry out the second leg of the research, the phase 3 trial, in the aforementioned countries and some five other nations. Italy, one of the worst-affected countries, is to be included in the phase 3 trial.
In the phase 3 trial, Celltrion will test regdanvimab on 720 patients to see if the test results return identical or similar values as the phase 2 trial.
Celltrion will also undergo another clinical phase 3 trial for some 1,000 asymptomatic people who have come in close contact with confirmed patients. The company will monitor how many of the candidates treated with regdanvimab become confirmed patients after 14 days.
Betting on the success of the drug, Celltrion began mass production of CT-P59 in September, and has enough stock for some 100,000 people.
As of Tuesday, Korea has had an accumulated 58,725 confirmed patients, of which 40,703 have been released upon recovery. At press time, the officially tallied number of quarantined patients stood at 17,163.
Celltrion is establishing plans to develop CT-P59 for a maximum 1.5 million to 2 million people annually by building more manufacturing sites. Vice Chairman Kee said that come next year, Celltrion will assign one plant to just produce regdanvimab, and nothing else.
The company’s Plant 1 and Plant 2 in Songdo, Incheon, have production capacity of 100,000 liters and 90,000 liters of mammalian biologics substance, respectively. Celltrion has started building a third plant, with a capacity of 60,000 liters. The company’s goal is to build overseas sites, and bring the total capacity up to 390,000 liters.
By Lim Jeong-yeo (firstname.lastname@example.org