S.Korea's Celltrion gets approval for Phase 3 trials of COVID-19 antibody drug

iStock [illustration]

South Korean drugmaker Celltrion Inc said on Monday it has received regulatory approval for Phase 3 clinical trials of an experimental COVID-19 treatment.

The approval comes as the company plans to seek conditional approval for its antibody-drug, CT-P59, for emergency use by the end of this year.

The treatment, the most advanced antibody-drug in terms of research in South Korea, is directed against the surface of the virus and designed to block it from locking on to human cells.

The third stage trials will be conducted on some 1,000 asymptomatic coronavirus patients and those who have come into close contact with COVID-19 patients in Korea, Celltrion said in a statement.

The Ministry of Food and Drug Safety recently approved a Phase 2/3 study on patients with mild and moderate cases of COVID-19, Lee Sang-joon, Celltrion's senior executive vice president, told Reuters.

Celltrion began commercial production of the drug in September - likely to amount to around 1 million doses - in anticipation of demand in both domestic and overseas markets.

In July, Celltrion separately launched overseas human trials of its treatment in Britain.

More from International news

  • India inspects spice makers over alleged contamination

    India is inspecting facilities of spice makers MDH and Everest for compliance with quality standards after sales of some of their products were halted in Hong Kong and Singapore for allegedly containing high levels of a cancer-causing pesticide.

  • Israeli media predict offensive in Gaza's Rafah soon

    Israel is poised to send troops into Rafah, the Gazan city it sees as the last bastion of Hamas, Israeli media reported on Wednesday, saying preparations were under way to evacuate war-displaced Palestinian civilians who have been sheltering there.

  • Russia detains ally of Defence Minister Shoigu for corruption

    A Russian court on Wednesday ordered one of Defence Minister Sergei Shoigu's deputies be kept in custody on suspicion of taking bribes, the highest-profile corruption case since President Vladimir Putin sent troops into Ukraine in 2022.

  • Trump meets with Japan's former prime minister Aso

    Former Japanese Prime Minister Taro Aso, a senior figure in the country's ruling party, met with Donald Trump on Tuesday, becoming the latest US ally seeking to establish ties with the Republican presidential candidate.

News