Celltrion’s Corona 19 antibody treatment,’Rekirona (development name CT-P59)’, the clinical phase 2 results showed that both efficacy and stability were secured, and the first Korean Corona 19 drug was launched into the countdown.
In particular, as it is confirmed that it has demonstrated efficacy beyond the existing Corona 19 antibody treatments released by global pharmaceutical companies, expectations for entry into overseas markets are also increasing.
According to the results of phase 2 clinical trials of Rekirona, released at the ‘2021 High1 New Drug Development Symposium’ conference held by the Korean Pharmacopoeia on the 13th, it was found that it has a better therapeutic effect than competitors’ products in specific evaluation indicators. Joong-sil Eom, a professor of infectious medicine at Gil Hospital, Gachon University, who participated in the clinical trial of Rekkirona, revealed the drug’s efficacy, safety, and strengths compared to other products at the presentation.
Celltrion applied for conditional permission to the Ministry of Food and Drug Safety with the results of phase 2 clinical trials saying, “Clinical results have been confirmed to be excellent in terms of efficacy and safety” through a press release on the 29th of last month. Currently, the Ministry of Food and Drug Safety is conducting a survey on medical institutions that have conducted clinical trials with a preliminary review based on the data submitted by Celltrion. If Rekkirona gets approval from the Ministry of Food and Drug Safety this month, it will be the second and first domestically produced COVID-19 treatment, following’Remdesivir’ of Gilead Sciences, a multinational pharmaceutical company, as the approved COVID-19 treatment in Korea. As soon as Celltrion received conditional approval, it was decided to launch Rekkirona on the market at a cost level without profit. Celltrion’s Songdo plant has completed production of Rekirona for 100,000 people, and plans to supply 1.5 to 2 million treatments depending on the situation of Corona 19 at home and abroad.
Apart from its domestic launch, Celltrion plans to apply for emergency use approval for global market launches in the US and Europe during this month. Celltrion is evaluated to be highly likely to obtain overseas marketing approval as it has previously discussed phase 2 clinical trials with the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), and a large number of local patients participated in the clinical trial.
Rekirona is a 960mg intravenous drug that targets mild and moderate patients with Corona 19, not severe or severe. It is predicted that the market demand may be much higher as it is said to be priced lower than that of Lilly or Regeneron treatment that has already been released and used. It is known that the selling price of Lily and Regeneron antibody treatments in the US ranges from 4 million to 4.5 million won, while Celltrion plans to supply them overseas at a lower price of 3 million won.
Celltrion has always emphasized that Rekirona has excellent efficacy and safety as a treatment for Corona 19, so it is not inferior to being released in global markets such as the US as well as in Korea.
Celltrion R&D Headquarters Kwon Ki-seong said at a debate held at the National Assembly on the 12th, “Lilyna regeneron antibody treatment, which was approved for urgent use in the United States last year, for the reduction of virus reduction time, time for recovery, and the proportion of patients requiring hospitalization through phase 2 clinical trials. Compared to and obtained at least equal or higher results,” he said. In addition, Celltrion Vice Chairman Ki Woo-sung also expressed confidence in the quality of Rekkirona, saying, “It performs much better than other antibody treatments that have already been released, but it is difficult to talk about it before approval from the Food and Drug Administration.” Celltrion explained that it had the effect of shortening the patient’s recovery period by 44% through the results of phase 1 clinical trials in patients with mild Corona 19 last November. Based on the results of phase 2 clinical trials, Celltrion will be conducting phase 3 clinical trials for 720 patients with Corona 19 around the world soon.
[김병호 기자 / 김시균 기자]
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