The government has recently authorized Covid-19 therapy Regkirona, developed by Celltrion, more than a year-and-a-half after the nation recorded the first confirmed case in early 2020.
Now the challenge for most drugmakers here is more convenient oral therapy.
The Ministry of Food and Drug Safety recently approved Regkirona for treating high-risk groups over 50, expanding from the conditional authorization in treating patients older than 60 or those suffering from mild Covid-19 symptoms with underlying diseases.
Although outflanked by Celltrion in becoming the first Korean company that developed Covid-19 therapy, other domestic pharmaceutical companies are making progress in their studies of oral Covid-19 therapies. The government had announced that it would prepurchase oral Covid-19 treatments developed by global pharmaceutical companies.
“There are no approved oral Covid-19 treatments yet, but the government is monitoring how the situation develops,” an official said.
“We are considering signing contracts to secure oral Covid-19 therapies among those that have entered phase 3 clinical trials, said Bae Kyung-taek, general situation controller at the Central Quarantine Countermeasure Headquarters.
The Korea Disease Control and Prevention Agency (KCDC) has set aside the 36.2 billion won ($30.7 million) to buy oral Covid-19 treatments this and next year.
Among the global pharmaceutical companies, MSD, Pfizer, and Roche develop and show outcomes in their oral Covid-19 treatment candidates.
MSD, called Merck in the U.S. and Canada, initiated a rolling submission to Health Canada for its oral Covid-19 therapy candidate, molnupiravir, in August.
“Oral treatments are costly, but they are more convenient as patients can avoid hospitalization and treated with injections,” Bae said. “Patients can acquire oral medicines with prescription, which might change the current state of the pandemic as patients can check their condition at home instead of being hospitalized.”
Domestic pharmaceutical companies’ ongoing research of oral Covid-19 treatments also draws interest because their products are likely to be cheaper than their global rivals.
Among Korean pharmaceutical companies developing Covid-19 therapies, Daewoong Pharmaceutical, Shinpoong Pharm, GeneOne Life Science, and Crystal Genomics have been conducting studies to check the safety and efficacy of their existing drugs in treating Covid-19 by repurposing them as oral therapies.
Daewoong is speeding up its studies of Foistar (ingredient: camostat mesylate) in treating Covid-19. It completed phase 2 clinical trials and released the top-line results in July. The company had previously failed to provide clinically significant developments in the initial report due to limited participants. However, it plans to present a more comprehensive result after completing the studies this time around.
“The final results and analysis of our phase 2 clinical trial are expected to come out within this month, and we expect to verify the efficacy from the outcomes or through the phase 3 study,” a Daewoong official said.
Shinpoong Pharm is also conducting phase 2 and 3 clinical trials of its malaria treatment Pyramax to repurpose it as an oral treatment for Covid-19. The company plans to recruit 1,420 patients with mild to moderate Covid-19 patients in the phase 3 study.
“We believe our medicine to become an oral treatment that prevents Covid-19 patients from developing to severe stages and provide convenient administration with an appropriate drug price,” a Shinpoong official said.
GeneOne Life Science received approval to conduct a phase 2 clinical trial of Covid-19 drug candidate GLS-1027 to qualify safety and efficacy in treating Covid-19.
Crystal Genomics is also conducting a phase 2 study of its camostat-based candidate material to develop it as oral Covid-19 therapy.