Korea’s Celltrion Pushes for Broader Use of COVID-19 Treatment both Domestically And Abroad

South Korean pharma giant Celltrion has made a lot of breakthroughs on its COVID-19 treatment recently. On August 10th, the company said it had received approval from Australia’s Therapeutic Good Administration (TGA) for the clinical trial of its inhalable form of COVID-19 treatment, Regkirona, CT-P59.

Also, the application for the Phase 3 trial of Regkirona in Korea is under review by Korea’s Ministry of Food and Drug Safety. Regkirona was approved by the agency in December 2020. This intravenous antibody treatment is currently used to treat severe patients. In the Phase 3 trial, Celltrion will verify its safety and efficacy in a wider range of patients with mild COVID-19 over 12 years of age.

Clinical Trial of Inhaled Regkirona Approved by Australian Government

The inhaled form of Regkirona is developed under the collaboration between Celltrion and North California-based Inhalon Biopharma. Since last July, the two companies have embarked on the development and have finished the animal studies of inhaled Regkirona this January.

The Phase 1 clinical trial in Australia will involve 24 healthy people, and the next phase of the trial will be launched later this year, to verify the efficacy of the treatment. 

Approval Status Among Other Countries

Regkirona has just won Emergency Use Authorization by the Brazilian health regulator, allowing its use on hospitalized patients. Earlier in July, it also received Emergency Use Authorization from the Indonesian government.

The drug is currently under rolling review by the European Medicines Agency. In addition, Celltrion plans to apply for Emergency Use Authorization from the USFDA as well.

Author

Kathy Huang

We are, and will remain, perpetual newbies. - Kevin Kelly