Celltrion Corona Treatment Restrictions on Target Administration… Narrowing the width of mild patients

The targets of patients receiving Celltrion Corona 19 treatment were more limited than the original target. However, as the screening process crossed the 9th ridge, it became possible to expect permission before the Lunar New Year holiday.

According to related industries on the 28th, the Ministry of Food and Drug Safety (hereinafter referred to as the Ministry of Food and Drug Safety) held the first verification advisory group for Celltrion’Rekkironaju’ and the 2nd Central Pharmacist Review Committee (hereinafter referred to as the Central Pharmacopoeia) advisory meeting. A conclusion was drawn to recommend permission. The last procedure left until approval is the 3rd final inspection committee.

A distinct difference in the opinion of experts up to the second round is the subject of administration patients. It was initially changed from’mild patients and moderate patients’ to’mild high risk patients and moderate patients’.

The administration of mild patients was limited to’high risk groups’. Regarding this, Yu-hwan, chairman of the Central Pharmacopoeia, explained, “It is because, when looking at the results of phase 2 clinical trials of Rekirona, we could not confirm a statistically significant treatment effect in mild patients.”

He added, “It is a mild patient, but it is recommended that it be used in limited patients if the medical staff judges that it is a high risk group and serious side effects are expected.”

This is less than the result of Celltrion’s goal of rapid administration to mild patients with the use of Rekyrona as’early diagnosis-early treatment’ in the development process.

Experts recommended that although no serious adverse events have occurred due to the administration of Rekironaju, phase 3 clinical trials should be conducted in sufficient patients and continuous safety evaluation after the market is required.

It is meaningful that the opinions of experts on Rekirona state exceeded the 9th part ridge as they concluded with a recommendation for approval based on phase 3 clinical trials.

It has taken a step further as the first domestic corona treatment. It is concluded that there is no disagreement with the approval as experts have acknowledged the need for domestic patients in Rekirona.

Therefore, attention is also being drawn to the timing of approval of conditional permits in Rekirona state. The final expert meeting, the final inspection committee, remained, but in fact, only the procedure remained until approval.

An industry insider observed, “If you look at the current progress, there is a high possibility that a permit will be issued before the Lunar New Year holiday,” and “the government will have no choice but to mind the spread of corona after the holiday.”

Celltrion is ready for approval. An official from Celltrion said, “When Rekirona receives conditional approval from the Ministry of Food and Drug Safety, it has already finished producing 100,000 people so that it can be supplied to the medical field immediately.”