Daewoong Pharmaceutical and Chong Kun Dang Also Accelerate Approval Applications
On the 24th, when the domestic situation of the novel coronavirus infection (COVID-19) showed a gradual decline, medical staff were collecting specimens at a temporary screening clinic set up in the plaza of Seoul Station. The Central Disease Control Headquarters of the Korea Disease Control and Prevention Agency announced that as of midnight on the same day, 392 new COVID-19 cases were confirmed, bringing the total to 75,084. Photo by Moon Honam munonam@
[Asia Economy Reporter Kim Ji-hee] The likelihood of conditional approval for Celltrion's novel coronavirus (COVID-19) antibody treatment 'Rekkironaju' has increased. On the 27th, the Central Pharmaceutical Affairs Deliberation Committee, the second expert advisory procedure of the Ministry of Food and Drug Safety, issued an advisory opinion stating that "approval can be granted on the condition of submitting Phase 3 clinical trial results." If subsequent procedures proceed smoothly, product approval originally scheduled for early next month is expected to be possible.
The approval and review process for COVID-19 treatments follows the sequence: 'application submission → preliminary review → examination and on-site investigation → advisory → approval.' Previously, authorities decided to conduct expedited reviews within 40 days for COVID-19 treatments and vaccines. Rekkironaju is currently at the advisory stage. Having passed the first advisory procedure, the Verification Advisory Group meeting on the 17th, and then the Central Pharmaceutical Affairs Deliberation Committee meeting the day before, the final step, the Final Inspection Committee, remains. Once passed, product approval will become visible.
Since both previous advisory groups recommended conditional approval, it is expected that the Final Inspection Committee, which includes internal and external experts from the Ministry of Food and Drug Safety, will also pass smoothly. If approved, the 100,000 doses produced by Celltrion will be immediately available for supply.
The variable in the final approval decision is likely to be not the approval itself but whether mild patients will be included as recipients. The Central Pharmaceutical Affairs Deliberation Committee recommended the day before that the drug should be administered to mild patients in high-risk groups and moderate patients, showing a slightly different opinion from the earlier Verification Advisory Group. The Verification Advisory Group had taken the position that administration to mild patients was appropriate. Oh Il-hwan, chairman of the Central Pharmaceutical Affairs Deliberation Committee, said, "Considering the results of the submitted Phase 2 clinical trial comprehensively, the statistical verification method at the start of the initial clinical trial was not established for mild patients, and a sufficient number of patients was not secured, so statistically significant therapeutic effects could not be confirmed," adding, "administration is recommended for moderate patients and mild patients in high-risk groups."
With the approval of the first domestically produced COVID-19 treatment approaching, the second and third domestic treatments following Rekkironaju are also preparing for their debut.
First, Daewoong Pharmaceutical plans to apply for conditional approval for 'Hoistar Tablets,' currently under development as a COVID-19 treatment, as early as this month. Hoistar Tablets recently demonstrated rapid virus elimination and symptom improvement effects in Phase 2 clinical trials. Hoistar Tablets have also received approval to conduct Phase 3 clinical trials to prove preventive effects.
Chong Kun Dang's 'Napabeltan' is also on the verge of applying for conditional approval from the Ministry of Food and Drug Safety. Previously, symptom improvement effects were confirmed in a Russian Phase 2 clinical trial involving about 100 severe patients. Based on these results, they plan to proceed with the approval application. GC Green Cross's plasma treatment 'GC5131A' is also in the final stages of preparation for conditional approval application. Phase 2 clinical trials have already been completed.
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