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| Celltrion, a leading biopharmaceutical company based in Incheon's Songdo, unveiled to the public its potential COVID-19 antibody treatment known as CT-P59, Dec. 22. / Yonhap |
By Lee Hyo-jin
While both vaccines and treatments are needed in order to bring the COVID-19 pandemic under control, Korea seems to be showing faster progress in developing treatments compared to its vaccine development and procurement plans.
The Ministry of Food and Drug Safety has approved a total of 29 clinical trials of potential COVID-19 treatments from domestic drug companies, among which 21 trials were underway as of Dec. 23.
As several firms have recently announced promising results from their clinical trials, hopes are rising that the treatments may be commercialized for actual use soon, with a goal of release as early as January.
Among them, Celltrion, a leading biopharmaceutical company based in Incheon's Songdo, unveiled to the public, Dec. 22, its treatment candidate known as CT-P59 (regdanvimab), a monoclonal antibody treatment, which it has been working on since May.
On Nov. 25, it finished its Phase 2 clinical trial involving 327 participants with various symptoms of COVID-19 from several countries including Korea, the U.S. and Spain. The firm will soon announce the results of the trial after analyzing detailed data such as efficacy, safety and the appropriate number of doses required for each patient.
Its next step is to apply for special approval for use to the Korea Disease Control and Prevention Agency (KDCA) by the end of this year. The approval system, which will take about 40 days for the health authorities to decide on, exceptionally allows preliminary use of the medication in hospitals before its formal approval.
The firm added that it has already produced around 100,000 doses of the antiviral drug for immediate distribution upon approval.
Prime Minister Chung Sye-kyun, who visited Celltrion's production center in Incheon, Dec. 22, expressed hopes that the treatment candidate, if developed successfully, will be "a ray of hope" in the pandemic.
Another domestic drug firm leading the treatment race is GC Pharma. Its investigational plasma therapy, known as GC5131, is an infusion of blood plasma from people who have fully recovered from the coronavirus. The method has been considered one of the effective treatment options since the early stages of the pandemic.
GC Pharma said it will share in coming days the interim results of its second-phase clinical trial involving 60 high-risk patients, which is showing notable progress.
The safety and efficacy of the plasma therapy has already been proven as a total of 26 patients are currently being treated with it as of Dec. 23, following the government approval for conditional usage in critical-condition patients at several hospitals including Samsung Medical Center and Ajou University Hospital.
Earlier in October, GC5131 was administered to a patient with severe COVID-19 symptoms in his 70s who was hospitalized at Kyungpook Hospital in Chilgok, North Gyeongsang Province. He fully recovered following the treatment.
Other pharmaceutical companies are developing treatments through drug repurposing, identifying new therapeutic use in existing drugs that are already being used against other illnesses.
Daewoong Pharmaceutical has finished a phase 2 clinical trial of its treatment candidate Foistar Tab, involving 89 COVID-19 patients with mild symptoms. The medication is initially used to treat patients with acute pancreatitis.
The firm announced the topline data from the clinical trial, Dec. 22, saying that the speed of virus elimination using Foistar Tab was faster than the placebo group. DWRX2003, another potential treatment of Daewoong, is currently going through its phase 1 clinical trial.
Chong Kun Dang Pharmaceutical has won approval of its treatment candidate Nafabeltan from Australia's drug authorities to begin phase 3 clinical trials, Dec. 14. It will be able to join the Australian COVID-19 Trial (ASCOT), involving over 2,000 participants and 70 medical institutions from Australia, New Zealand and India.
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