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| Samples of Celltrion's COVID-19 antibody treatment Regkirona / Courtesy of Celltrion |
By Kim Jae-heun
Australia's Therapeutic Goods Administration (TGA) said Tuesday it has conditionally approved Celltrion's COVID-19 antibody treatment Regkirona for use in the country.
Many shareholders of the Korean biopharmaceutical company expected the announcement to lift its stock price, but it seems to have had no effect. Celltrion stocks to a plunge from 291,000 won on Sept. 23 to 193,500 won on Nov. 8.
On Tuesday, despite the approval notice, Celltrion stocks fell by 1.45 percent to finish at 203,500 won on the KOSPI, according to data by the bourse operator Korea Exchange (KRX).
Earlier, approval of Regkirona's distribution in Europe failed to help Celltrion's stock price. Europe, along with Australia, was considered a region that will help the local biopharmaceutical company to improve its value.
This year has been tough for Celltrion as the overall industry has been on a losing streak. The company announced its plan recently to develop a customized inhaled medication for the Omicron variant, but it does not seem to be pushing up the stock price, said officials.
Celltrion submitted preclinical data to the TGA on Regkirona's effectiveness treating numerous variants including Delta and the results of its large-scale phase 3 clinical tests. The Australian health authority has granted a provisional registration of Regkirona for high-risk patients with mild cases and patients with serious cases both for adults.
Celltrion confirmed the safety and effectiveness of its treatment through the global phase 3 clinical testing conducted on 1,315 COVID-19 patients in 13 countries including Korea, the United States, Spain and Romania. In particular, Regkirona was effective in preventing patients in the high-risk group from developing serious COVID-19 infections by 72 percent compared to those in the placebo group.
"We will do our best to prevent the spread of COVID-19 in Australia, where the number of confirmed cases is on the rise due to the prolonged pandemic and the spread of new variants," a Celltrion official said.
