HONG KONG – Celltrion Inc. has received conditional marketing authorization (CMA) from the Ministry of Food and Drug Safety (MFDS) for its anti-COVID-19 monoclonal antibody, Regkirona (regdanvimab, also known as CT-P59), in South Korea. It’s the first company to receive approval for a COVID-19 antibody treatment developed in South Korea, a MFDS spokesman told BioWorld.

The green light, which came a little more than a month after Celltrion sought it, will allow the company to market Regkirona for patients aged 60 and older. Other beneficiaries include those at higher risk, suffering from cardiovascular or chronic respiratory disease, diabetes or high blood pressure, as well as adults with mild or moderate COVID-19 symptoms.

Celltrion is already looking outside South Korea for further regulatory approvals. “Phase III trials are currently under way in around ten countries worldwide targeting the recruitment of 1,172 COVID-19 patients with mild to moderate symptoms. We are in negotiations with regulators in key overseas countries to obtain emergency use approval,” a Celltrion representative told BioWorld.

Two of those regulators are the EMA and FDA, where Celltrion is seeking a CMA and an emergency use authorization, respectively.

The phase III trials will take place in more than 10 global sites and will evaluate Regkirona’s efficacy and safety. Another aim is to demonstrate Regkirona’s clinical efficacy against the B1.351 variant of SARS-CoV-2, first identified in South Africa, and the B 1.1.7 variant, first identified in the U.K., with results expected in the coming days, the company said.

“In partnership with the Korea Disease Control and Prevention Agency, Celltrion has continuously been conducting tests for COVID-19 mutations and is currently checking the latest mutation strains. We plan to actively respond to future new mutations by conducting neutralization tests,” said the representative.

The CMA from MFDS was based on the first part of a randomized, double-blind and placebo-controlled global phase II/III trial. The results showed that patients treated with Regkirona were at a significantly reduced risk of COVID-19-related hospitalization and oxygenation up to Day 28. The trial also showed that progression rates to severe COVID-19 were reduced by 54% for patients with mild-to-moderate symptoms and 68% for moderate patients aged 50 years and older.

The results also showed a significantly shortened time to clinical recovery in patients treated with 40mg/kg of Regkirona that ranged from 3.4 days to 6.4 days quicker compared with patients treated with a placebo.

Celltrion also reported positive results in a small early-stage trial for its antibody at the Korean Society of Infectious Diseases’ 2020 fall conference on Nov. 5, 2020. The study showed that patients treated with Regkirona recovered at least 44% faster that those who received a  placebo. Regkirona was well-tolerated in the study with no clinically significant safety issues and no patients treated with the drug requiring hospitalization or other antiviral therapies as a result of COVID-19 at the time of the presentation.

From start to finish

Celltrion was so confident in the drug that it ramped up production from September 2020 onwards to aid in the fight against COVID-19. South Korea has had 81,487 confirmed COVID-19 cases as of Feb. 9, according to Johns Hopkins University data.

“With the pandemic still raging in Korea, we believe today’s CMA of Regkirona marks an important milestone in the fight against COVID-19,” said Ho Ung Kim, head of the medical and marketing division at Celltrion Healthcare.

“Patients with COVID-19 in Korea now have access to a therapy according to the authorized indications early in the course of their infection. We remain committed to closely working with the regulatory agencies worldwide including the FDA and the EMA to ensure that patients around the world have access to safe and effective treatment against COVID-19 as in the case of Korea,” Kim added.

In other news, Jung-Jin Seo stepped down as Celltrion’s CEO at the end of December 2020. “Seo has stepped down from day-to-day management but was determined to take responsibility for Regkirona’s development until the end,” Celltrion’s representative said.