Celltrion Receives UK Approval for Phase 1 Clinical Trial of COVID-19 Antibody Treatment

[Asia Economy Reporter Cho Hyun-ui] Celltrion announced that it received approval for the clinical trial application (IND) of its COVID-19 antibody treatment 'CT-P59' from the UK Medicines and Healthcare products Regulatory Agency (MHRA) on the 29th (local time).

The UK Phase 1 clinical trial will focus on confirming initial indicators of drug efficacy such as viral neutralization and therapeutic effects in mild COVID-19 patients, in collaboration with GC Green Cross, which has applied for a Phase 2 clinical trial of a COVID plasma treatment.

After the UK Phase 1 trial, Celltrion plans to conduct a total of two clinical trials targeting mild and moderate patients through global Phase 2 and 3 trials. The company aims to secure interim results for these trials by the end of this year and also conduct a prevention trial for close contacts, with results expected by the first quarter of next year. To this end, Celltrion is preparing for global Phase 2 and 3 trials in consultation with other European countries.

In Korea, the Ministry of Food and Drug Safety approved the clinical trial application for CT-P59 on the 17th. Currently, a Phase 1 trial is underway at Chungnam National University Hospital with 32 healthy subjects, aiming to obtain results within the third quarter.

Celltrion will begin full-scale commercial production starting in September to enable immediate mass supply once CT-P59 development is completed next year. Taking into account existing product inventory and production plans, Celltrion will ensure uninterrupted supply of existing products to the global market and has also initiated plans to adjust production capacity for CT-P59 supply in the coming year.

Lee Sang-jun, Senior Vice President and Head of Clinical Development at Celltrion, stated, “We are thoroughly preparing to ensure the smooth completion of large-scale global Phase 2 and 3 clinical trials.”

This content was produced with the assistance of AI translation services.