South Korea’s major pharmaceutical companies are racing for the No. 2 title in the development of a coronavirus cure following the country’s first commercially available therapy Rekirona developed by Celltrion Inc. to treat Covid-19 patients with moderate symptoms.
According to the Ministry of Food and Drug Safety on Monday, a total of 15 candidate Covid-19 treatments are being tested, with ChongKunDang (CKD), GC Pharma and Daewoong Pharmaceutical making the final leg to the finish line to deliver their cure version.
CKD and GC Pharma are among the most promising players as they already completed Phase 2 clinical trials. CKD is a bit ahead as it plans to file for marketing approval of Napabeltan with the ministry this month. CKD said the approval process will begin as soon as clinical trial data compiled in Russia arrives, and marketing authorization is expected next month.
The ministry is set to grant approval to Covid-19 vaccines and cures within 40 days under a fast-track review process, which means Napabeltan may be clinically used in April or May.
Napabeltan that was repurposed from acute pancreatitis therapy has been tested as a potential Covid-19 cure to treat patients with severe symptoms.
GC Pharma is also working on data submission for marketing authorization of its Covid-19 candidate cure GC5131A, a high concentration plasma treatment from immune proteins containing various antibodies in the blood plasma of patients recovering from coronavirus infection. A Phase 2 clinical trial of 60 Covid-19 patients with old age, pneumonia and other underlying conditions was completed and clinical data will be analyzed within the first quarter ahead of the company’s application for conditional marketing approval in early April. Approval may be granted in May or June.
Daewoong Pharmaceutical is seeking commercial availability of its chronic pancreatitis therapy Foistar as an off-label oral drug against Covid-19. The company expects commercial supply within the first half of this year.
By Kim Si-gyun and Minu Kim
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