South Korea, which is struggling to secure COVID-19 vaccines developed by foreign firms like Pfizer and Moderna, can’t expect local alternatives anytime soon, as Korean drugmakers are not making speedy progress as hoped in their vaccine development, industry sources said Sunday.
Even firms that have reached the clinical trial stage are having difficulties in securing volunteers with the vaccination campaign underway, the sources said.
South Korean drugmakers Genexine and Cellid are currently leading the local development of COVID-19 vaccines, but they have not started phase three clinical studies yet.
Genexine expects to see the results of its 2a clinical trial in July this year and plans to wrap up the phase two clinical study to request the Ministry of Food and Drug Safety for a conditional approval by the end of this year.
Genexine is the first South Korean company that started developing COVID-19 vaccines. Last June, the company received an approval for a clinical study of its COVID-19 vaccine candidate GX-19. But, the company in December changed the substance to GX-19N and decided to begin reconducting clinical studies for the vaccine candidate that could potentially respond to the COVID-19 variants.
Cellid is expected to announce the results of the company’s phase one clinical trial at the Pharmaceutical Society of Korea this week. In the meantime, the South Korean drug maker is conducting its phase two clinical trial with 120 patients.
“(Cellid) aims to receive a conditional approval from the health authority and start phase three clinical study in August,” said Cellid CEO Kang Chang-yul said.
Kang, however, noted that it could be difficult to secure 3,000 to 4,000 patients for the phase three clinical trial if a large amount of foreign COVID-19 vaccines arrives in the country by that time.
Other South Korean drugmakers are speeding up their development procedures but have still remained at phase one and two clinical studies as well.
SK Bioscience is conducting phase one and two clinical trials at the same time for two COVID-19 vaccine candidates, NBP2001 and GBP510. The company aims to start phase three clinical trial for at least one of the two vaccine candidates.
Gene One Life Science in December received an approval to conduct phase one and two clinical studies. The company is expected to complete phase one clinical study during the first half this year. It will then soon start phase 2a clinical trial with around 300 patients, with an aim of beginning phase three clinical trial by the end of this year.
EuBiologics, the last one who joined the COVID-19 vaccine development race here, received approvals for phase one and two clinical studies in January.
Local pharmaceutical industry sources pointed out that local drugmakers have relatively less experience in developing drugs for infectious diseases and less resources they could invest in making novel drugs, compared to foreign pharmaceutical giants.
By Shim Woo-hyun (email@example.com