Controversy over efficacy continues
“It’s irresponsible to say that’poison’ is not effective for severely ill patients.”
![Celltrion Group's honorary chairman Seo Jeong-jin held an online press conference on the 18th and made a presentation on Rekkironaju. [사진 = 유튜브 화면 캡쳐]](https://i0.wp.com/news.google.com/news/photo/202102/69692_41109_1853.jpg?w=560&ssl=1)
[오늘경제 = 최주혁 기자]
Celltrion Group Honorary Chairman Seo Jeong-jin responded to some concerns and suspicions related to the clinical results of the new coronavirus infection (Corona 19) antibody treatment’Recyronaju’ (ingredient name Regdanvimab CT-P59), which was conditionally approved “They rebutted.
He was confident that if he used the antibody platform he possessed while explaining the clinical results of Rekirona, he would be able to respond to any COVID-19 mutation in the future.
Honorary Chairman Seo revealed discomfort at the online press conference on the 18th, when some medical experts judged that the effect of shortening the symptom improvement time in mild patients was not statistically significant, and conducted a phase 2 clinical trial for mild and moderate symptoms. The results were once again revealed, and future plans were explained.
Among the high-risk patients infected with Corona 19,’Rekironaju’, which is scheduled to be used only for mild and moderate patients,’is not effective for mutant viruses, or may have adverse effects that adversely affect them’,’for severe patients It is at the center of Gapron Park, in line with claims that it can be poisonous when administered, and that it is not effective for mild patients.
In fact, at the beginning of this month, the head of the Central Infectious Disease Hospital Operation Center of the National Medical Center, Bae Bae-hwan, expressed concern that if antibody treatments were administered to severely ill patients, they could cause excessive immune reactions and become poison.
According to the industry, Celltrion developed the Corona 19 antibody treatment “Recyronaju” and recently received conditional approval from the Ministry of Food and Drug Safety. Rekironaju has been supplied to medical institutions nationwide from the previous day. Celltrion is supplying the drug at manufacturing cost, and there is no cost to the patient.
Celltrion clarified on the day that Rekirona was not able to secure some statistical significance in clinical practice, pointed out that it was not effective for mild patients, and clarified concerns that antibody therapy could be rather’toxic’ to severe patients.
Honorary Chairman Seo said at this meeting, “There are a lot of stories about statistical significance. How can all the effects of reducing the virus and shortening the recovery period appearing in 300 people be a coincidence?” “How can drugs for pneumonia be used for mild patients? Could it not be effective?”
It also actively clarified concerns that antibody treatments may cause an ADE (antibody-dependent enhancement) reaction in severely ill patients and become’toxic’. ADE means that a person who has been given an antibody or vaccine against the virus will be infected with a mutant virus in the future, and the symptoms will be much worse.
Honorary Chairman Seo said, “ADE was not reported from patients with Corona 19. Isn’t it too irresponsible to express this as’poison’ rather than medicine?” He said, “Even if you blame me, I hope you don’t blame the company that secured the technology sovereignty for the treatment of corona.”
On the same day, Celltrion also emphasized that it was fully prepared to respond to the’Corona 19 mutation’. Celltrion has already announced on the 11th that it has begun developing a’mutation-tailored treatment’, and announced that it will complete clinical trials within 6 months.
Regarding this, honorary chairman Seo said, “If there is a serious problem with the domestic supply of the Corona 19 vaccine, we will directly enter into the development of the vaccine,” he said. “Korea has certainly had technological sovereignty in diagnosis and treatment, but vaccines have not yet been secured. “If sovereignty becomes a problem, I’m thinking whether I should go into (direct development).”
In the mutant situation, additional vaccines (bivalent and trivalent vaccines) must be released, but if domestic supply is delayed, it is read with a willingness to consider entering the vaccine industry.
It is known that the company has also secured the ability to create corona 19 virus antigens in the process of developing the antibody treatment drug’Rekironaju’. Antigens are sites where antibodies bind to neutralize the virus.
Honorary Chairman Seo, in particular, against the suspicion of collusion with the politicians, said, “How can it be seen as an adhesion in providing a remedy to the manufacturing cost?” He said, “In order to develop a virus treatment such as Corona 19, government support and cooperation are necessary,” he said. “There were government subsidies, of course, but this was only a part of the subsidies, but it was not developed by subsidies.”
“Since the number of patients (327 patients) who participated in the phase 2 clinical trial is small, there may be questions about the statistical significance,” said Kim Seong-hyun, chief of clinical planning for Celltrion, who attended the meeting. “It’s to check consistency.”
He emphasized that the effect was also confirmed, especially for mild patients. He said, “Even in mild patients, the time it takes for clinical recovery has been shortened by more than 2 days.” It’s different from” he said.
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