Input 2021.02.17 10:27
Seo Jeong-jin “I will explain the misunderstood part of the people.”
Celltrion “On-line on Thursday and Friday regarding recent issues”
With the spread of COVID-19 antibody treatments to medical institutions nationwide on the 17th, it will be interpreted as a measure to reliably end the controversy about the efficacy of mutant viruses or mild patients that are still continuing. An official from Celltrion said on the day, “We will comprehensively explain and answer inquiries on recent issues in Rekirona, including the mutant virus.” The meeting will be broadcast live on YouTube, and a specific schedule will be set as early as this afternoon.
Chairman Seo also met Kang-rip Kim, head of the Ministry of Food and Drug Safety, who visited the Celltrion Plant 2 in Songdo, Incheon on the 8th, and said, “We will explain what the public may misunderstand after the Lunar New Year holiday.” I will summarize and talk about the contents that I developed.”
Recently, the state of Rekirona has revealed a weakness in that it cannot cure the mutant virus originating in South Africa. As a result of an experiment on the efficacy of Rekkirona for the mutant virus, which was released by the Korea Centers for Disease Control and Prevention on the 11th, it was found that the treatment can cure the British mutant, but for the South African mutant, “(treatment effect) is hardly found. Earlier this month, the head of the National Medical Center’s Infectious Diseases Hospital Operation Center, Bae Bae, was concerned that the antibody therapy could not only be powerless against the mutant virus, but also could have an adverse effect on helping cells penetrate and proliferate.
As of the 14th, the number of confirmed South African mutant viruses in Korea is still small, but the spread is 1.5 times stronger than the existing virus and the reinfection rate is high, so it is likely to become a dominant species in the future. It’s an anxiety factor for Rekironaju. Celltrion announced immediately after the announcement by the Korean National Disease Service Agency, “We will complete the development and clinical trials of a new antibody treatment with efficacy against the South African mutant virus within 6 months.”
Attention is also drawn to the progress and future schedule of the phase 3 clinical trial currently in progress on 1170 patients. This is because Rekirona can be used in all mild patients only after the phase 3 trial is completed. Celltrion is in a hurry with a plan to complete the phase 3 test within three months.
Before the approval of the Ministry of Food and Drug Safety, it was expected to be effective in preventing severe progression when administered to mild patients in the early stages of infection. Licensed for limited use. This is because a statistically significant treatment effect could not be confirmed because sufficient number of mild patients could not be secured in clinical trials.
Some questions about the future plans of domestic supply, which began on this day, are expected to be resolved at the meeting. Celltrion is in the state of producing additional parts in addition to 100,000 people prepared in advance before approval from the Ministry of Food and Drug Safety.
It is known that Chairman Seo will hold an online interview with Thomas Burn, chairman of the Korea Society, a non-profit organization aimed at promoting cooperation between the United States and Korea, on the 20th as well as reveal the vision of Celltrion.