As Celltrion’s self-developed novel coronavirus infection (Corona 19) antibody treatment has been released clinical data, there is a growing expectation that a’native’ treatment will soon appear.
According to the pharmaceutical and bio industry on the 14th, as Celltrion’s Rekkironaju (ingredient name Legdanvimab, code name CT-P59) seems to have taken the place of the “domestic No. 1” Corona 19 treatment, GC Green Cross, Daewoong Pharmaceutical, and Chong Kun Dang are also other pharmaceutical companies. The province also started working on a permit application.
Celltrion’s Rekironaju was found to have lowered the incidence of severe patients as well as the time it takes to recover as a result of a global phase 2 clinical trial targeting mild and moderate corona19 patients.
It has proven its effectiveness as a treatment for Corona 19, and there is no problem in safety, so there is no obstacle to approval.
The Ministry of Food and Drug Safety said that if the treatment effect is confirmed in phase 2 clinical trials as a result of the review of Rekirona, product approval can be considered as a condition for submitting the results of phase 3 clinical trials. Inside and outside the industry, it is expected that product approval from the Ministry of Food and Drug Safety will come out as early as the end of this month.
If Celltrion’s Rekirona state is licensed, it becomes the’domestic No. 1’COVID-19 treatment. Currently, Vecluriju (ingredient name remdesivir) of Gilead Sciences, a multinational pharmaceutical company, is the only product approved by the Ministry of Food and Drug Safety as a treatment for Corona 19 in Korea.
Following Celltrion, competition for the second’native’ COVID-19 treatment position is also fierce.
GC Green Cross has developed a blood system drug’GC5131A’ for severely ill patients with Corona 19, and has completed a phase 2 clinical trial conducted on 60 patients. The results are currently being drawn, and based on this, it plans to apply for a conditional permit to the Ministry of Food and Drug Safety within one quarter.
Daewoong Pharmaceutical and Chong Kun Dang accelerated research through the’drug re-creation’ method of developing existing drugs as a treatment for Corona 19.
Daewoong Pharmaceutical is developing it as a treatment for Corona 19 in the form of taking Hoy Star tablet (ingredient name chamostat mesylate) used for chronic pancreatitis. It set the goal of launching as a drug that can be widely prescribed in parallel for both mild and severe patients.
Park Hyun-jin, head of Daewoong Pharm’s development headquarters, attended a discussion meeting recently held in the National Assembly and said, “(Hoi Star Jeong-eun) will apply for emergency use approval because statistically significant results have been obtained from high-risk patients.
Daewoong Pharmaceutical plans to apply for conditional approval in consultation with the government as soon as the final analysis of the results of Phase 2a clinical trial of Hoystar is completed.
Chong Kun Dang has completed phase 2 clinical trials in Russia to develop a blood anticoagulant and acute pancreatitis drug’Napabeltan’ (ingredient name Napamostat) as a treatment for COVID-19.
An official from Chong Kun Dang said, “First of all, as phase 2 clinical medication has been completed in Russia, we plan to apply for conditional approval by drawing results within this month.”
In addition, among domestic pharmaceutical and bio companies, Bukwang Pharm, NG Chem Life Science, Shinpoong Pharm, Crystal Genomics, Dong Wha Pharm, and Immunmed are conducting phase 2 clinical trials to develop COVID-19 treatment.