Shortening the treatment period, should the bed be solved… Anticipation of Celltrion Treatment

Celltrion submitted an application for conditional approval for the new coronavirus infection (Corona 19) antibody treatment “Reckironaju” (CT-P59) to the Ministry of Food and Drug Safety on the 29th. The expectation for this is growing. CT-P59 is the third case of applying for approval from the authorities after Eli Lilly and Regeneron of the United States among the COVID-19 antibody treatments being developed worldwide.

Experts say, “It is welcome to see the increase in drugs that can be used in the medical field upon approval.” At the same time, it is carefully approaching whether it can become a’game changer’. This is because specific clinical data related to safety or efficacy have not yet been disclosed, and that it can be used only in patients with mild symptoms rather than gastric or severe symptoms.

Celltrion said, “We completed phase 2 of the global clinical trial of CT-P59, a corona19 antibody treatment as planned, and submitted an application for conditional approval to the Ministry of Food and Drug Safety today (29th).” It was announced on the same day that the procedure for obtaining approval will be initiated.” However, it is a policy that detailed clinical data related to the safety and efficacy of CT-P59 will be kept private until there is a separate guideline from the Ministry of Food and Drug Safety. The Ministry of Food and Drug Safety, which has begun the approval review, aims to process it within 40 days.

CT-P59 is an antibody treatment product made by screening for neutralizing antibodies present in the blood of a cure for Corona 19. It is intended for patients with mild to moderate corona19. In terms of inhibiting the proliferation of the virus, it should be administered within a week of symptom onset to be effective. 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. Antibody treatments from Regeneron and Eli Lilly are also intended for mild patients. Experts say that there is no virus treatment for severely ill patients yet.

Nevertheless, medical experts responded, saying, “If the number of drugs available in the field increases, it would be welcome.” In particular, in Korea, where the early diagnosis system is relatively developed, it is expected that the rate at which treatment can be applied will be high. If the antibody therapy is effective as described by Celltrion, it has the advantage of reducing the burden on the medical system by shortening the treatment period for the confirmed patient. 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.

However, there were also concerns regarding the method of administration. Celltrion’s antibody treatment was developed as an injection that is administered intravenously for about 90 minutes. Choi Won-seok, a professor of infectious medicine at Korea University Ansan Hospital, said, “If an antibody treatment is approved, it is a strategy that medical staff should use if possible.” . It is explained that there may be restrictions on how to use it because it does not end with the doctor’s prescription and administration guidance like the medicine you eat. Professor Choi added, “It is also necessary to think about how to overcome this part and use it.”

In the end, in order to assess the effectiveness of the treatment, it must be proven whether the virus in the patient’s body in the early stage of infection is excreted more quickly and the rate of progression to severe disease is significantly less. In particular, the key is how effective it is in high-risk groups, such as the elderly, who are at high risk of becoming severe. In response, Celltrion said, “We plan to announce the results of phase 2 clinical trials including this part in detail at an international conference soon.”

Regarding the quantity and price of supply, it is the position that “we will supply the necessary amount domestically at cost”. Celltrion has already finished producing antibody treatments for 100,000 people, and plans to supply 1.5 to 2 million antibodies for COVID-19 next year. Regeneron and Eli Lilly cost more than 1 million won per vaccination in the United States. In this regard, Celltrion Chairman Seo Jeong-jin appeared on a radio program last month and said, “Since our own companies must play the role of public goods in the country, we will supply antibody treatments to Korea at cost. It will be a tenth lower price than the US,” he said.

Reporter Kwon Yujin [email protected]