[FETV=김창수 기자] Celltrion’s Corona 19 antibody treatment’Recyronaju (CT-P59)’ received a passing score from the pharmaceutical authorities. On the 18th, the Ministry of Food and Drug Safety (KFDA) disclosed the results of the verification advisory group meeting for phase 2 clinical trials in Rekkirona and proposed to grant’conditional approval’ on the premise of a phase 3 clinical trial.
Celltrion is expected to generate sales of 600 billion won for 300,000 people this year and 300 billion won in 2022 through Rekkirona. Up to now, Rekironaju is evaluated as having similar or better effects to existing overseas antibody treatments such as Lily and Regeneron, and its use for mild and severe patients is promising.
◆ Food and Drug Administration Advisory Committee meeting’passing point’… In front of phase 3 clinical trials = The Ministry of Food and Drug Safety held a meeting of the’Corona 19 Treatment/Vaccine Safety/Effective Verification Advisory Group (Advisory Group)’ meeting to review the results of phase 2 clinical trials of Rekirona on the 17th and revealed the results on the 18th.
In the global phase 2 results of Celltrion’s 327 mild to moderate Corona 19 confirmed patients, the patient who received the drug recovered from the symptoms of Corona 19 as soon as about 3.43 days. It took 5.34 days for patients who received Rekirona to recover and 8.77 days for patients who received placebo (a fake drug).
The verification advisory group judged that “the reduction in the time for improvement of corona 19 symptoms by administering this drug is statistically significant and clinically significant.” However, there was no significant difference between the patient taking the drug and the patient who did not receive the virus negative transition time (the time to convert from positive to negative virus), which is a measure of the drug’s operating principle.
In addition, in terms of safety, minor or moderately severe adverse events occurred, but compared to the placebo group, the rate was similar and there were no serious adverse events. Hypertriglyceridemia, hypercalcemia, etc. that occurred after taking this drug were confirmed in phase 1 and were predictable.
In summarizing the results, the advisory group proposed to grant an item on the premise of conducting a phase 3 clinical trial in Rekkirona. The advisory group also recommended that a sufficient number of patients in phase 3 should be confirmed to significantly reduce the severity of mild to moderate to severe morbidity. This is interpreted as having received a’pass score’ before consulting the Central Pharmacy Review Committee.
◆ “It’s no less than an overseas treatment… Active Export Expectations” = In the announcement of the results of Phase 2 clinical trials of Rekirona, which was unveiled on the 13th, Celltrion expressed the opinion that Rekirona has similar or superior effects to existing overseas antibody treatments such as Lily and Regeneron. In addition, based on the domestic clinical trials, the industry and stock market predict that if Rekkirona is marketed, active overseas sales will occur.
Han Byeong-hwa, a researcher at Eugene Investment & Securities, said, “Reekyronaju is expected to apply for emergency approval to the US FDA and European EMA in January and February, and approval and export will begin at the same time within two quarters.” Assuming that, we estimate the sales of 300 billion won for 300,000 people in 2021 and 300 billion won for 150,000 people in 2022.”
A researcher also added, “Celltrion’s production-based sales are estimated at 300 billion won in 2021 and 150 billion won in 2022, based on 50% of the final sales.” He added, “The standard for overseas governments to stockpile drugs is between competing drugs. It will be the drug efficacy and price,” he predicted. “There is no reason why Rekyrona can not be chosen over other drugs.”