Korean remedy that “prevents severe progression of infected people” as early as next month

Korean remedy that “prevents severe progression of infected people” as early as next month

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On the 22nd, a researcher is looking at a COVID-19 antibody treatment in a laboratory at Incheon Celltrion Plant 2, which is developing an antibody treatment for a novel coronavirus infection (Corona 19). This is the first time the treatment has been released to the media and is currently in clinical trials. [연합뉴스]

On the 22nd, a researcher is looking at a COVID-19 antibody treatment in a laboratory at Incheon Celltrion Plant 2, which is developing an antibody treatment for a novel coronavirus infection (Corona 19). This is the first time the treatment has been released to the media and is currently in clinical trials. [연합뉴스]

While the spread of the novel coronavirus infection (Corona 19) remains unabated, interest is gathering whether Celltrion’s treatment could become the first line of defense for the pandemic. Celltrion plans to apply for conditional use of the COVID-19 antibody treatment drug developed by the Ministry of Food and Drug Safety as early as 29th. The conditional approval of the Ministry of Food and Drug Safety is a system that grants marketing permission only with the results of phase 2 clinically under the condition that if there is no treatment for a specific disease, a separate phase 3 clinical trial will be conducted. It is expected that the treatment can be used in the medical field as early as January-February next year after the approval process of the Ministry of Food and Drug Safety. We have summarized the questions related to this.

What is Antibody Therapy
Antibody therapy is a biopharmaceutical used as a therapeutic by separating the most effective antibody formed in the body after Corona 19 infection. It is a principle that prevents the virus from functioning by sticking to a specific protein (antigen). U.S. Regeneron and Eli Lilly were approved by the Food and Drug Administration (FDA) for urgent use of antibody treatments last month. This is a new drug for Corona 19 and is different from the re-creation of drugs (remdesivir and dexamethasone) that use existing drugs as a treatment for Corona 19.

Can Antibody Therapy Treat All Corona 19 Patients?
It is not. Antibody therapy is intended for mild patients with relatively mild symptoms. If administered at the beginning of the onset, severe progression can be prevented. Therefore, it must be administered within a week of symptom onset to see the effect. This is because patients who have entered severe disease have already significantly reduced the virus itself, making it difficult to see the effect of the treatment. In fact, it should be said that there is still no virus treatment for severely ill patients. Antibody treatments from Regeneron and Eli Lilly are also intended for mild patients.
The appearance of the novel coronavirus caught in an electron microscope. [연합뉴스]

The appearance of the novel coronavirus caught in an electron microscope. [연합뉴스]

Then, what are the benefits of antibody therapy?
By shortening the treatment period for confirmed patients, the overall burden on the medical system can be reduced. This is because the number of deaths while waiting for hospitalization due to a shortage of beds has recently increased, and if the treatment period per person is shortened by administering a treatment, the operation of the hospital bed can be breathless.

It is said that antibody therapy can also serve as a’short-term vaccine’.
Vaccines do not put antibodies directly into the body, but rather put in’fake antigens’ to make antigens that fight viruses. In other words, it induces the immune system to make antibodies. If the virus invades later, antibodies made by the immune system suppress it. In comparison, Celltrion’s antibody therapy is literally injecting antibodies directly. Therefore, short-term virus prevention effects can also be expected. This is because the antibody is able to block viruses coming in from outside for 1 to 2 weeks in the body. Celltrion also conducted a’prevention clinical’ to confirm the effect of preventing infection when an antibody treatment is administered to close contacts of corona19 confirmed patients.

With the spread of new coronavirus infection (Corona 19), there are several cases of waiting at home due to the lack of hospital beds nationwide. On the afternoon of the 22nd, Hongseong Medical Center in Hongseong, Chungcheongnam-do expanded 80 beds dedicated to severely ill patients with negative pressure devices installed. The photo shows a room dedicated to severely ill patients with negative pressure installed. 20 [뉴스1]

With the spread of new coronavirus infection (Corona 19), there are several cases of waiting at home due to the lack of hospital beds nationwide. On the afternoon of the 22nd, Hongseong Medical Center in Hongseong, Chungcheongnam-do expanded 80 beds dedicated to severely ill patients with negative pressure devices installed. The photo shows a room dedicated to severely ill patients with negative pressure installed. 20 [뉴스1]

Is it possible to approve from January to February next year?
The Ministry of Food and Drug Safety currently has a team dedicated to the approval of Corona 19 vaccines and treatments, and aims to shorten the screening period that took more than 180 days to within 40 days. Therefore, if Celltrion antibody treatment’CT-P59′ satisfies the screening criteria, it is expected to be used in the medical field from January to February next year. Celltrion has analyzed safety and efficacy data after completing medication for 327 corona19 patients in Global Phase 2 on the 25th of last month. Along with the conditional license, this data will be released soon.

Celltrion began production of CT-P59, which can be treated for about 100,000 domestic Corona19 patients from last September at the Songdo production facility, so that if conditional approval is granted, it can be used immediately in the medical field. Currently, the initial volume production has been completed. In addition, in the near future, it is expected to conduct global phase 3 clinical trials in more than 10 countries around the world.

Reporter Kwon Yujin [email protected]


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