Input 2021.01.14 16:45
Fierce competition among pharmaceutical companies with the goal of domestic 2nd COVID-19 treatment
Currently, Remdesivir, produced by Gilead Sciences, an American pharmaceutical company, is the only drug approved in Korea as a treatment for Corona 19. In addition, it is noteworthy whether other pharmaceutical/bio companies such as GC Green Cross, Chong Kun Dang, Daewoong Pharmaceutical, Shinpoong Pharmaceutical, and Cellibury could become a’game changer’ that surpasses Celltrion treatment by starting clinical and licensing procedures.
According to the pharmaceutical industry on the 14th, when Celltrion’s Rekironaju applied for conditional permission, GC Green Cross, Daewoong Pharmaceutical, and Chong Kundang began a procedure for the treatment of Corona 19 treatment.
◇ Celltrion “Half the recovery period in phase 2 clinical trials for antibody treatments”
Celltrion announced the results of Phase 2 clinical trials for 327 patients with mild to moderate Corona 19 through the electronic disclosure system (DART) and the’High1 New Drug Development Symposia’, an academic conference hosted by the Korean Pharmacy Society. Revealed.
As a result, Rekironaju was found to reduce the incidence of severe patients requiring inpatient treatment by 54% in all patients and 68% in moderately ill patients over 50. In addition, the time until clinical recovery from the disappearance of Corona 19 symptoms disappeared was 5.4 days in the Rekirona injection group and 8.8 days in the placebo group. The company explained that the recovery period was shortened by more than 3 days in the Rekirona injection group. Celltrion R&D Headquarters Kwon Ki-seong said at a discussion meeting held in the National Assembly, “We have confirmed the effect of more than equivalent to that of the US pharmaceutical company Lily Regeneron’s antibody treatment.”
Experts’ evaluations of Rekirona are mixed. Eom Jung-sik, a professor of infectious medicine at the Catholic University’s Gil Hospital, explained, “The rate of virus suppression was remarkably high in the treatment group.” On the other hand, Kim Woo-ju, a professor of infectious medicine at Kodae Guro Hospital, said, “It is difficult to become a’game changer’ only with the clinical data released by Celltrion.” In the case of high-risk groups such as chronic disease patients, if it worsens to severe, it can be fatal. In that case, administration will reduce the number of hospitalizations.” Prof. Kim added, “There are also concerns about the safety of (Celltrion treatment). It seems that close verification is needed.”
◇ Reduce applications for conditional approval for COVID-19 treatments such as GC Green Cross, Daewoong Pharmaceutical, and Chong Kun Dang
As Celltrion is ahead of the conditional approval of the Corona 19 treatment, competition among pharmaceutical companies aiming to become the’Korean No. 2 Corona Treatment’ is also continuing.
Conditional authorization is a system that grants marketing authorization so that drugs can be used only with the results of phase 2 under the condition of separately proceeding with phase 3 clinical trials when there is no treatment for a specific disease.
GC Green Cross developed the blood system drug’GC5131A’ for severely ill patients with Corona 19, and completed a phase 2 clinical trial conducted on 60 patients. Blood treatment agents can be made by separating antibodies with immunogenicity from plasma of a cure for COVID-19. The company is currently drawing results and plans to apply for a conditional permit to the Ministry of Food and Drug Safety within one quarter based on this.
Chong Kun Dang is conducting research in a’drug re-creation’ method of developing existing drugs as a treatment for Corona 19 again through clinical trials. Chong Kun Dang has completed phase 2 clinical trials for blood anticoagulant and acute pancreatitis drug Napabeltan (ingredient name Napamostat) in Russia. Chong Kun Dang announced the results of phase 2 clinical trials in Russia for more than 100 severely ill patients with Corona 19, and announced that Napa Veltan, under development, showed about 2.9 times higher therapeutic effect in high-risk patients than in the standard treatment group. Chong Kun Dang plans to apply for conditional permission after analyzing the results this month.
Daewoong Pharmaceutical is also planning to apply for permission to treat Corona 19 through drug re-creation. It is being developed as a treatment for Corona 19 in the form of taking Hoystar tablets (ingredient name chamostatmesylate) used for chronic pancreatitis. It plans to launch a drug that can be widely prescribed by conducting clinical trials for both mild and severe patients. Upon completion of the final analysis of the results of phase 2a clinical trials, conditional approval will be applied.
In addition, Shinpoong Pharm, Dong Wha Pharm, Bukwang Pharm, NG Chem Life Science, and Crystal Genomics are conducting clinical trials for the development of COVID-19 treatment. Bukwang Pharmaceutical is developing a Corona 19 treatment gel for Levovir, a hepatitis B treatment, introduced in 2007. Shinpoong Pharmaceutical is testing’Piramax’, which is used as a treatment for malaria, as a treatment for Corona 19, and Donghwa Pharmaceutical is testing’DW2008S’, a natural drug that is being developed as a treatment for asthma.
Cellibury, a biotech company, is confident that the immunotherapy’iCP-NI’, which is being developed in-house, has been proven to reduce the mortality rate by 80% in the Corona 19 death model. In the COVID-19 death model, the mortality rate in the placebo group was 79%, while the mortality rate in the group administered iCP-NI for 3 days was only 16%, and the mortality rate from iCP-NI administration was reduced to 80%. Explained that it showed. The company plans to inform US and European pharmaceutical companies about the therapeutic efficacy of these COVID-19 treatments through individual meetings at the JPMorgan conference. iCP-NI is expected to undergo clinical trials as an immunotherapy for COVID-19 in the United States.
The world, including Korea, selects’vaccines’ as a key weapon in responding to Corona 19. However, there are opinions that there is also a need for effective treatments that can cope with the prolonged pandemic. In Korea, a total of 15 COVID-19 treatments are being developed. A medical official said, “It is better to have a corona19 treatment than to have it,” he said. “Because of the delay in supplying the vaccine to Korea, it is the current situation to prevent the symptoms of chronic diseases and the elderly from worsening through corona19 treatment. It is an urgent task. I expect that the domestic treatment will play such a role.”