Celltrion applies for COVID-19 antibody treatment license… Food and Drug Administration Review
Mass production is possible… Expected to be effective against mutant viruses
The disadvantage of the high price… Domestic flight cost, overseas flight competitive price
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The introduction of a’domestic’ novel coronavirus infection (Corona 19) treatment was made visible.
On the 29th, Celltrion applied to the Ministry of Food and Drug Safety for an item permission for the COVID-19 antibody treatment “Recyronaju” (ingredient name regdanvimab, code name CT-P59), and the approval authorities also applied for approval and review within 40 days. It is said that it will be completed, and expectations for rapid adoption are growing. Joon-wook Kwon, head of the 2nd vice-president of the Central Defense Response Headquarters, said at a briefing on the Corona 19 outbreak on the same day, “Domestic treatments are in sight due to the constant efforts of R&D workers.
Celltrion is positively evaluating the results of the global phase 2 clinical trial of the Corona 19 treatment submitted while applying for conditional approval to the Ministry of Food and Drug Safety. Currently, the results of phase 2 clinical trials have not been disclosed in detail, but the company is in a position that this data is sufficient grounds to apply for conditional approval from the KFDA.
Accordingly, the industry expects that if the approval and review of the COVID-19 treatment by the Ministry of Food and Drug Safety is completed within 40 days without difficulty, it will be possible to introduce it in Korea soon.
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Celltrion previously revealed that the Corona 19 antibody treatment had the effect of reducing the time it took to recover symptoms in phase 1 clinical trials by 44% compared to the placebo group. Celltrion Group Chairman Seo Jeong-jin also revealed that the Corona 19 antibody treatment had the effect of killing the virus within 4 to 5 days in the clinical trial.
Authorities and industry point out that Celltrion’s COVID-19 antibody treatment is easy to’mass production’. Since this treatment is produced through a process of genetic recombination and selection of neutralizing antibodies that neutralize the Corona 19 virus from the blood of the corona 19 cure car, mass production is possible without the need to continuously collect antibodies. Along with this, Celltrion believes that the Corona 19 antibody treatment can also have an effect on mutant viruses.
However, the’high price’ of antibody therapy has been pointed out as a disadvantage. Lily and Regeneron’s COVID-19 antibody treatment, which have been approved for emergency use in the United States, are known to cost more than 1 million won per dose. According to foreign media, the US government decided to buy 300,000 doses of Lily’s antibody treatment at the end of October, spending $375 million (about KRW 418.9 billion). When calculated in one vial (bottle), it is about $1,250 (about 1.34 million won).
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Celltrion has not yet confirmed the supply price of the COVID-19 antibody treatment, but has repeatedly announced that it will supply it at the’cost’ level in Korea. Celltrion Group Chairman Seo Jeong-jin appeared on a radio broadcast and said that the price would be decided in the vicinity of 400,000 won, showing his will to supply the Corona 19 antibody treatment to Korea at cost. An official from Celltrion said, “We are establishing a strategy for pricing policy,” and said, “We will supply at a cost level domestically and at a competitive price compared to competing products, although globally more expensive than domestic.
Celltrion has already finished producing antibody treatments that can be used by 100,000 corona19 patients. Next year, it plans to produce 1.5 million to 2 million people’s treatment.
/ Reporter Park Ye-na [email protected]
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