Celltrion is expected to launch its COVID-19 treatment as early as this month, raising hopes that it will be able to combat the new coronavirus strain which is causing fear due to its high transmissibility.
The company said it has applied for conditional approval for its CT-P59 treatment from the Ministry of Food and Drug Safety. Conditional approval is given to a new drug that has finished Phase 2 clinical trials, if there is no other treatment for the disease. The drug developer is required to continue with and finish full clinical trials at the same time.
Hours after receiving Celltrion's application, the ministry said it has begun its review.
Earlier this week, the ministry said it will shorten the review period for drugs to treat COVID-19 from 180 days to 40 days. Given this, the treatment is anticipated to become available in late January.
The Phase 2 trials were conducted on 327 patients in Korea, Romania, Spain and the U.S., and final treatment injections took place Nov. 25. Celltrion said it decided to apply for domestic approval immediately after the trials, because "the company believes it has secured enough evidence and data to file for approval."
Since the trials were designed in coordination with the ministry, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency, the company is expecting the emergency approval processes to proceed smoothly in those regions. The company plans to apply for emergency use authorization in the U.S. and Europe next month, and will launch contiguous Phase 3 clinical trials in 10 countries soon.
If Celltrion's treatment gets domestic approval, it will be the world's third company to develop a COVID-19 treatment from scratch, following Eli Lilly and Regeneron.
In a conference held Monday, Celltrion Vice Chairman Kee Woo-sung said CT-P59 is designed for the early treatment of mild COVID-19 cases, and the company has confirmed that the drug is effective against all variants of the coronavirus.
The fear over new COVID-19 strains is growing in Korea. The Central Disease Control Headquarters has confirmed that a mutated coronavirus strain that's been spreading in the U.K. infected three Koreans who entered Korea, Dec. 23.
Overseas news outlets are reporting that the variant could be up to 70 percent more infectious than others already in circulation. Though the government said Tuesday there is "slim chance of the U.K. variant circulating in the country," public fear is growing as the U.K. and other variants are spreading rapidly across the globe.
Following Celltrion's announcement, the company's share price rose, closing at 360,500 won, Tuesday, up 10.8 percent from the previous session.
As conditional approval is expected, Celltrion sent text messages to its employees and executives Sunday asking for them to stop trading any shares they held in the company and its two listed affiliates.
"Due to our development of a COVID-19 treatment, public attention is high on employees' and executives' trading of company shares," the message read. "Until the treatment gets approval, employees and their family members are asked not to trade listed Celltrion Group shares."
The message, however, came after eight executives and their family members sold more than 30,000 Celltrion shares. Of them, Celltrion Holdings Vice Chairman Yoo Heon-young sold 10,000 shares, worth about 3.6 billion won, followed by Executive Director Baek Kyung-min who sold 7,078 shares worth 2.5 billion won.
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