GENE ONLINE|News &
Opinion
Blog

2021-08-12| Asia-Pacific

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

by Kathy Huang
Share To

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.

©www.geneonline.com All rights reserved. Collaborate with us: service@geneonlineasia.com
Related Post
The U.S. COVID-19 Public Health Emergency Ends in May, but FDA’s EUA Authority Remains
2023-02-01
Novavax Begins Phase 2 For COVID-19/Influenza Combination And Stand-Alone Flu Shots
2023-01-03
Jounce Sells Anti-CCR8 Antibody to Gilead, Forgoing $645 Million In Milestones
2022-12-28
LATEST
AbbVie Unveils Latest Data For Skyrizi In Difficult-To-Treat Psoriasis
2023-03-20
Sanofi Slashes Insulin Prices by Up to 78% Following Hot On the Heels of Major Competitors
2023-03-19
Novartis Snags Pediatric Brain Cancer Indication for Oncology Combination Therapy
2023-03-19
Pfizer, Astellas’ Prostate Cancer Drug Xtandi Achieves Goals In Phase 3
2023-03-19
Amgen Faces Class Action Lawsuit for Concealing $10.7 Billion Tax Bill to Manipulate Stock Price
2023-03-16
ImmunoPrecise Antibodies, Libera Bio Ink $155 Million Pact To Deliver Antibodies With Nanotechnology
2023-03-16
Dermavant Eyes Second Vtama Indication with Topline Atopic Dermatitis Results
2023-03-15
Scroll to Top