▲Celltrion Corona 19 antibody treatment’Rekironaju’ (Yonhap News)
The use of a new coronavirus infection (Corona 19) treatment developed by a Korean company is imminent. Conditional approval of up to four corona19 treatments is expected to be possible only in the first quarter of this year, including the fastest antibody treatment.
According to the Ministry of Food and Drug Safety and the industry on the 6th, Celltrion, GC Green Cross, Daewoong Pharmaceutical, and Chong Kundang are among the domestic companies developing COVID-19 treatments that have entered the visibility for conditional approval. Conditional authorization is a system that allows patients to use medicines under the condition of conducting phase 3 clinical trials in the case of life-threatening diseases or diseases that cannot be treated with existing treatments.
On the 29th of last month, Celltrion applied for conditional permission for the COVID-19 neutralizing antibody treatment’Rekironaju 960mg’ (ingredient name Regdanvimab). It is a therapeutic agent developed by recombination with host cells capable of mass production after selecting and collecting neutralizing antibody genes present in the blood of a cure for Corona 19, and mass production through cell culture is possible without constant supply of antibodies.
(Graphic = Reporter Son Mi-kyung sssmk@)
The Ministry of Food and Drug Safety has introduced a high-intensity rapid productization promotion program (GO Rapid Program) to quickly approve the approval of COVID-19 treatment and vaccine. Accordingly, the review period for Rekkirona is shortened to a maximum of 40 days, including holidays. This means that the review must be completed by the 7th of next month at the latest.
The government has pledged to extend the screening period and decide whether to approve it in January. Accordingly, it is expected that the approval of a domestic treatment will be decided within a year after the first corona 1 infection in Korea.
Rekironaju is an injection that is administered intravenously for 90 minutes. It is not an alternative treatment for severely ill patients after clinical trials for mild to moderate patients. The remaining phase 3 clinical trials will also be conducted for patients with mild to moderate symptoms.
During this month, up to three domestic pharmaceutical companies are planning to apply for COVID-19 conditional permission from the Ministry of Food and Drug Safety. GC Green Cross, Daewoong Pharm, and Chong Kun Dang are analyzing data after completing phase 2 clinical trials, and approval is possible within the first quarter by applying until mid-February.
GC Green Cross’s blood system drug’GC5131A’ can be administered to severely ill patients. As of the 5th, 28 cases were approved for use for treatment purposes, and one of them was confirmed.
A company official said, “Currently, we are speeding up the data derivation of phase 2 clinical trials,” and “We will apply for conditional approval from the Ministry of Food and Drug Safety at the beginning of the year.”
A blood system drug is made by fractionating an antibody with immunogenicity from the plasma of a cure for COVID-19. It is a method that has secured safety enough to be exempted from both phase 1 and 2 clinical trials overseas. However, it is difficult to mass-produce it because healers’ blood is constantly needed.
GC5131A is supplied free of charge to domestic patients. GC Green Cross decided to bear all costs from development to commercialization, excluding government subsidies, and there was no limit on the quantity of free supplies.
Daewoong Pharmaceutical and Chong Kun Dang, which have confirmed the efficacy of treating Corona 19 with previously developed drugs, are pushing for conditional approval in January.
Daewoong Pharmaceutical is developing’Hoystar tablet’ (ingredient name: Camostat mesylate), which is used as a treatment for reflux esophagitis after a chronic pancreatitis and gastrectomy, as a treatment for Corona 19. Previously, Jeon Seung-ho, president of Daewoong Pharmaceutical, said that he is speeding up the development of Hoy Star with the aim of using it in January. Since this drug is for oral use, it is more convenient to administer than injection.
Hoystar tablets did not secure statistical significance in the clinical phase 2a topline results. However, phase 2b and 3 clinical trials have already been approved by the Ministry of Food and Drug Safety, and on the 31st of last month, it entered phase 3 clinical trials for severely ill patients through combination with’remdesivir’.
In addition to Hoystar tablet, Daewoong Pharmaceutical is conducting phase 2 clinical trials with’Niclosamide’ (DWRX2003), an anthelmintic ingredient. Niclosamide, which is being developed jointly with Daewoong Therapeutics, has confirmed the removal of viruses, inhibition of cytokine storms, and improvement of respiratory distress in animal models. It plans to complete phase 2 clinical trials in the first half of the year.
A company official explained, “We will continue to consult with the government for prompt conditional approval,” and said, “The goal is to release two treatments within the year.”
Chong Kun Dang is applying for conditional approval based on the results of phase 2 clinical trials in Russia for the anticoagulant and acute pancreatitis drug Napabeltan (ingredient name Napamostat). Napa Beltan is also conducting global phase 3 clinical trials in Australia.
An official from Chong Kun Dang said, “The analysis of the results of phase 2 clinical trials is currently in progress,” and “We will discuss conditional approval with the Ministry of Food and Drug Safety in the middle and late January.”
In addition, Shinpoong Pharmaceutical, Donghwa Pharmaceutical, NG Chem Life Science, Crystal Genomics, and Bukwang Pharmaceutical are undergoing phase 2 clinical trials for COVID-19 treatment. Patient recruitment is the key to rapid clinical progress.
Shinpoong Pharmaceutical plans to complete phase 2 clinical trials of’Piramax’, a malaria treatment for mild to moderate Corona19 patients by April this year. A company official said, “Because the recruitment of patients was a little slow, the completion of phase 2 was postponed to April,” he said. “We are planning to apply for conditional permits in the first half of the year.”
As the Corona 19 pandemic (collective infection) passes the year, the value of securing not only vaccines but also treatments is increasing. Currently, the number of deaths in Korea exceeded 1,000 and the death toll in the world exceeded 1.8 million. The U.S. Food and Drug Administration (FDA) approved Regeneron and Eli Lilly’s antibody treatments for emergency use, respectively, but they did not spread widely in medical settings.
It is the industry’s calculation that if a domestic COVID-19 treatment is created before the vaccine is sufficiently distributed, commercial competitiveness can be secured both domestically and abroad. An industry official said, “Celltrion has already finished producing 100,000 people, and the drug re-creation method is a commercially available drug, so there will be no problem in supplying it,” he said. “It is most important to ensure adequate effects.”