Korean companies' progress in developing COVID-19 treatment

amid EUAs granted to foreign oral COVID-19 treatments

MFDS issues EUA for the use of Pfizer’s ‘Paxlovid’… to be introduced 1H this year

Shin Poong and Ildong to initiate clinical trials… key to their success depend on participant recruitment

News of the decision to introduce Pfizer’s oral COVID-19 treatment ‘Paxlovid’ in Korea from earlier this year has increased interest in the progress made in the development of oral COVID-19 treatments at Korean pharmaceutical companies.

 

The interest in when the homegrown oral COVID-19 treatments will be commercialized was triggered by the earlier-than-expected introduction of oral COVID-19 treatments from multinational pharmaceutical companies.

 

# According to the Ministry of Food and Drug Safety and industry sources on December 29th, Shin Poong Poong Pharmaceutical, Daewoong Pharmaceutical, Ildong Pharmaceutical, and Genencell are developing oral COVID-19 treatments.

 

The MFDS comprehensively had previously granted emergency use approval (EUA) of ‘Paxlovid (nirmatrelvir·ritonavir)' based on a comprehensive review of the results of the expert advisory meeting among others.

 

Paxlovid is indicated for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older, at least 40kg) who have positive COVID-19 results from PCR tests and are at high risk for progression to severe COVID-19.

 

In addition, the government purchased the oral treatment ‘molnupiravir’ from the US company MSD (Merck & Co.) in advance, confirming the introduction of COVID-19 treatments in Korea earlier this year.

 

Meanwhile, the oral COVID-19 treatment being developed by the domestic companies is in clinical stages.

 

The well-known Shin Poong Pharmaceutical’s ‘ Pyramax (pyronaridine-artesunate combination),’ the repositioned COVID-19 treatment in development, has entered Phase III trials after registering its first patient at the end of October.

 

# Daewoong Pharmaceutical has repositioned its Foistar tablet and is in clinical trials to develop the drug under the name ‘Coviblock’ for the ‘treatment of patients with mild-to-moderate COVID-19’ and ‘treatment of patients with severe COVID-19.’ Also, Ildong Pharmaceutical and Genencell have received MFDS approval for Phase II and III trials respectively for their oral COVID-19 treatments in development.

 

Dailypharm found that Ildong is planning to conduct a clinical trial and aims to register more than 200 patients with asymptomatic, mild, or moderate COVID-19 symptoms in Korea, and is currently recruiting participants from medical institutions, centered around Inha University Hospital.

 

An Ildong Pharmaceutical official said, “The Inha University Hospital is the lead clinic for our trial.

 

We are recruiting participants at 23 medical institutions including Inha and is also conducting a global clinical trial with the goal of receiving approval in the first half of this year.” The issue is that it is difficult to recruit participants in the course of clinical development for domestic oral treatments, which raises concerns over the disruption it may cause.

 

This issue has been repeatedly raised since the start of the development of homegrown COVID-19 treatments, and the pharmaceutical companies have set out to resolve the issue by conducting global clinical trials rather than domestic trials.

 

However, some expect that these latecomers will have sufficient competitiveness if they are sold at a lower price than that of Pfizer's or Merck's.

 

Price-wise, 30 tablets of Paxlovid are classified as a single course, and the US government has made an agreement for 10 million treatment courses of Paxlovid at 530 dollars (approximately 630,000 won) per course.

 

The US government has also signed for Merck’s molnupiravir at 700 dollars (approximately 830,000 won) per course.