Conditionally licensed for the COVID-19 antibody treatment’Rekirona’
Used for high-risk mild and moderate patients
Rekironaju, expects a meaningful role in overcoming COVID-19 with vaccines
[바이오타임즈] As of the 5th, the first new coronavirus infection (Corona 19) confirmed in Korea has exceeded 80,000 in one year, and the cumulative death toll is 1,459.
Corona vaccine vaccination is being done in the United States and Europe, but the situation of the Corona 19 pandemic is showing little signs of improvement.
Among these, the new coronavirus infection (Corona 19) treatment “Reekyronaju (ingredient legdanvimab)” developed by a Korean company Celltrion was approved as the No. 1 Corona 19 treatment in Korea. As an officially licensed antibody treatment, it is the third in the world after Eli Lilly and Regeneron in the United States.
On the 5th, the Ministry of Food and Drug Safety held a final inspection committee consisting of internal and external experts, and announced that it has decided to conditional approval for Celltrion’s Corona 19 antibody treatment drug’Rekirona’. The final inspection committee determined that the main data necessary for the permit review were faithfully submitted, and there was no problem in safety and effectiveness.
This permission was decided based on the safety and effectiveness results up to phase 2. Although it is a conditional permit that requires a separate phase 3 clinical trial to be submitted and the results are submitted, it is expected to play a meaningful role in overcoming COVID-19 with the vaccine and returning to daily life.
The final review committee, which was opened by the Ministry of Food and Drug Safety, has confirmed the range of treatment targets for Rekirona to be patients with mild to moderate symptoms in the high-risk group over 18 years of age. In the phase 2 clinical trial, the effect of using Rekyrona injection in general mild patients and severe pneumonia patients was not proven, so these were excluded from use.
The final inspection committee is the third advisory stage of the Ministry of Food and Drug Safety, following the verification advisory group and the Central Pharmacy Review Committee.
Previously, the verification advisory group recommended the treatment of mild to moderate patients over the age of 18 for Rekironaju, and the Central Pharmacopoeia recommended the treatment of patients with high-risk mild to moderate severity over the age of 18.
The high-risk group is 60 years of age or older or mild patients with an underlying disease (cardiovascular disease, chronic respiratory disease, diabetes, or hypertension). If you are 60 years of age or older, you can take the medication with or without an underlying disease. In addition, a moderately ill patient is a person who has pneumonia symptoms or has observed pneumonia through computed tomography (CT) or magnetic resonance imaging (MRI).
The method of use was approved to be injected intravenously for 90 minutes (±15 minutes) of this drug per 1 kg of adult body weight.
With this approval, the Ministry of Food and Drug Safety expects that Celltrion’s Rekkironaju will be available at the earliest time if requested at the clinical site, and is expected to proceed with the health insurance application procedure.
◇Rekironaju, expects a meaningful role in overcoming Corona 19 along with vaccines
Rekirona is a gene-recombinant neutralizing antibody treatment. The neutralizing antibody gene present in the blood of a cure for Corona 19 is selected and the gene is inserted (recombined) into a host cell capable of mass production, and mass-produced through cell culture.
Celltrion completed the discovery of candidate substances, animal tests, and phases 1 and 2 clinical trials within one year, and proved the safety and effectiveness of Rekirona.
Celltrion is currently testing whether it can respond to the COVID-19 mutant virus appearing in the UK and South Africa over the Korea Centers for Disease Control and Prevention and Rekirona, and will reveal its effect as early as next week.
Celltrion plans to secure statistical significance of Rekirona by entering Phase 3 clinical trials of Rekirona for 1,172 mild and moderate patients in 10 countries around the world. In addition, it plans to obtain emergency use approval (EUA) from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and sell it to countries where corona19 confirmed cases continue.
Some medical experts are of the opinion that this is a conditional license based on the premise of phase 3 clinical trials, so it is unreasonable to say that it is a game changer that will accelerate the end of Corona 19. However, there is also a high expectation that if it creates synergies with the vaccine, which will be vaccinated in February, it will definitely play a meaningful role in overcoming Corona 19 and returning to daily life.
In particular, it is highly likely to be exported as the third corona19 antibody treatment officially licensed in the world after Eli Lilly and Regeneron of the United States.
Eugene Investment & Securities raised the target price to 400,000 won, expecting that the Corona 19 treatment will be approved for overseas emergency use.
Han Byeong-hwa, a researcher at Eugene Investment & Securities, said, “Assuming that the overseas market price per capita is 2 million won, we estimate sales of 600 billion won for 300,000 people in 2021 and 300 billion won (for 150,000 people) in 2022.” Based on 50% of the sales, it was analyzed as 300 billion won this year and 150 billion won next year.”
In addition, “the US government’s first purchase of regeneron antibody therapy was 300,000 doses, and in the recent second purchase, 1.25 million doses were contracted for $ 2.63 billion.” “Considering this trend, Rekkirona It is highly likely that the exports of the company will exceed our estimates.”
Unlike general new drugs, corona treatments are sold through contracts between pharmaceutical companies and the government, and overseas approvals and exports are made because there is no reason for Rekkirona to be unselected compared to other drugs because the standard for storing treatments by overseas governments is the drug efficacy and price between competing drugs It is an opinion that the possibility is high.
Celltrion Rekirona should be statistically significant through phase 3 clinical trials. Even if it does not become a game changer by itself, it will certainly play a meaningful role in overcoming Corona 19 and returning to daily life with vaccines.
[바이오타임즈=김수진 기자] [email protected]
Copyright © BioTimes Unauthorized reproduction and redistribution prohibited