Celltrion(381,500 0.00%)The results of phase 2 clinical trials of Rekirona, a COVID-19 antibody treatment, were announced. It is analyzed that the possibility of emergency use approval of Rekirona is also high when compared with antibody treatments that have previously been approved for emergency use.
According to Celltrion et al. on the 14th, Rekironaju reduced the incidence of severe patients requiring inpatient treatment by 54% in all patients and 68% in moderately ill patients over 50 years old compared to the placebo group. The recovery period for all patients was reduced by 3.4 days compared to the placebo group, 5.1 days for moderately ill patients, and 6.4 days for patients over 50 years of age. Safety was also confirmed.
It is positive that the hospitalization period has been shortened in the elderly and high-risk groups.
Hye-min Heo, a researcher at Kiwoom Securities, said, “The factors that were mainly considered in the approval of overseas emergency use were the reduction in the number of hospital visits and the rate of hospitalization.” “We obtained emergency use approval in that the decrease in the number showed a correlation with the decrease in the number of visits to medical institutions.”
There were some cases where the’p value’ (data on the 28th) was more than 0.05, but considering the seriousness of the situation, he thought that it may not be difficult to judge. Usually, if the p value is less than 0.05, it is considered statistically significant, but the data on the 28th day of Rekirona showed more than 0.05. Since this may vary depending on the number of patients, it was estimated that it will prove statistical significance in phase 3 clinical trials.
Researcher Huh said, “Bamranibimab also did not meet the p value in all the data,” he said. “In the interim results announced before the emergency use approval, a p value of 0.7 was derived at the dose of 7000 mg, but it was approved as 0.38 of 700 mg.” .
For Celltrion’s share price, we believe that the sustainability and profitability of sales after approval will be more important than the emergency use approval itself.
Shinhan Investment Corp. is expected to be able to obtain emergency use approval from overseas as early as next month. Celltrion plans to apply for emergency use approval in the US and Europe as early as this month. Considering the previous case, approval in February is also possible.
Celltrion plans to produce treatments for up to 2 million people within this year according to the timing of approval in major countries. The domestic supply is estimated to be about 400,000 won, which is the cost level, and the overseas price is estimated to be 800,000 to 1 million won.
Lee Dong-gun, researcher at Shinhan Financial Investment, said, “Celltrion Healthcare, an overseas distributor.(169,800 0.00%)The sales without taking into account the distribution of profits with Wa are 1.6 trillion to 2 trillion won based on the supply of 2 million people,” he said. “If 50% of the supply for 1 million people is considered, it can be estimated at 800 billion to 1 trillion won.”
Reporter Minsoo Han [email protected]
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