Celltrion said that Regkirona (ingredient name: Regdanvimab), its Covid-19 antibody, has obtained conditional approval from the Australian Therapeutic Goods Administration (TGA).

The Australian health authorities have approved provisional registration of Lekkona for adults with mild and moderate symptoms of high-risk Covid-19 patients, according to Celltrion. The measure corresponds to conditional approval in other countries.

Australia had been praised as a Covid-19-free country thanks to the strong lockdown in large cities. However, the country recently saw a steady increase in new virus cases, raising the importance of treatment. According to Worldometer, a real-time statistics site for Covid-19, the country confirmed 1,691 cases on Dec. 4.

Celltrion confirmed the safety and efficacy of Regkirona with the results of a global phase 3 clinical trial conducted on 1,315 patients with mild and moderate Covid-19 in 13 countries around the world, including Korea, the U.S., Spain, and Romania.

In the high-risk group treated with Regkirona, the incidence of severe cases decreased by 72 percent compared to the placebo group. In addition, the clinical symptom improvement time was also shortened by more than 4.7 days.

“Based on the safety and efficacy proven through global clinical data of Regkirona, the company has obtained conditional approval status from the Australian health authorities for use as a treatment,” a company official said. “We will do our best to contribute to preventing the spread of Covid-19 in Australia, where the number of confirmed cases is increasing due to the prolonged Covid-19 outbreak and the spread of variant cases.”