Nafabeltan out, but push for homegrown COVID-19 drug continues

The competition to develop the country’s second COVID-19 treatment continues among South Korea’s major pharmaceutical companies after Chong Kun Dang Pharmaceutical recently dropped out.

South Korea’s Ministry of Food and Drug Safety announced Wednesday that it has decided not to approve Chong Kun Dang Pharmaceutical’s candidate, Nafabeltan, based on a review by its advisory board of its efficacy and safety.

Chong Kun Dang Pharmaceutical’s acute pancreatitis drug was one of two strong candidates to become the country’s No. 2 treatment for COVID-19, following Regkirona by Celltrion, which became the first commercially available therapy developed by a local firm in February.

Now, the next in line is GC Pharma’s blood plasma-derived therapy, GC5131A, which is intended to treat more serious COVID-19 cases.

Green Cross has finished phase two trial of its experimental COVID-19 blood plasma treatment drug GC5131A in December last year.

An official from Green Cross said the company plans to complete its analysis of its clinical data during the first half this year to apply for an emergency approval from the Drug Ministry in April.

The likelihood of Green Cross’s COVID-19 treatment getting approval from the ministry is relatively high, since the drug has already gained 41 therapeutic use approvals from the Drug Ministry upon requests from local hospitals.

Another candidate is Daewoong Pharmaceutical’s Foistar, a protease inhibitor repurposed to treat COVID-19 cases.

Daewoong is conducting larger clinical studies to test efficacy and safety of the drug after the company failed to derive statistically meaningful results in the previous clinical studies.

When Daewoong would apply for an approval, however, is not disclosed.

Other COVID-19 treatment candidates under clinical study include Bukwang Pharm’s clevudine, Shin Poong Pharm’s pyronaridine-artesunate, CrystalGenomics’ camostat, Dongwha Pharm’s DW2008S and Immunemed’s hsVSF-V13.

By Shim Woo-hyun (ws@heraldcorp.com)