Authorities "Plan for Mass Production of COVID-19 Antibody Therapeutics Within This Month" (Update)

Kwon Jun-wook, Deputy Director of the Central Disease Control Headquarters, is holding a regular briefing on the domestic occurrence status of COVID-19.
[Image source=Yonhap News]

[Asia Economy Reporters Heungsun Kim and Hyunui Cho] The quarantine authorities have presented a plan to mass-produce antibody therapeutics for the novel coronavirus infection (COVID-19) within this month.

On the afternoon of the 8th, Kwon Jun-wook, Deputy Head of the Central Disease Control Headquarters (CDCH), said at a regular briefing, "Currently, the Ministry of Food and Drug Safety is reviewing Phase 2 and Phase 3 clinical trials, and we plan to mass-produce commercial antibody therapeutics by September."

He explained, "After receiving approval from the Ministry of Food and Drug Safety for domestic Phase 1 clinical trials on July 17, we have completed and are analyzing the results of Phase 1. On July 29, Phase 1 clinical trials were approved in the United Kingdom, and after recruiting patients, the clinical trials are currently underway." He added, "Phase 1 clinical trials targeting mild domestic patients were also approved on August 25, and patient recruitment is currently ongoing."

According to the CDCH, the substance scheduled for mass production this month is for 'process verification' and will be produced at commercial production facilities. The process verification antibody therapeutics can be used for clinical purposes, and if approved after additional clinical trials, they can also be sold commercially.

Antibody therapeutics are drugs developed by culturing specific parts of COVID-19 antibodies derived from the blood of fully recovered patients to function as treatments. The government has been promoting clinical trials in the second half of this year with the goal of development by next year.

The CDCH also stated that on August 20, approval for Phase 2 clinical trials was obtained from the Ministry of Food and Drug Safety, and the safety and efficacy of plasma therapeutics are being confirmed in COVID-19 patients at six medical institutions. The clinical trial medical institutions are Samsung Seoul Hospital, Chung-Ang University Hospital, Seoul Asan Hospital, Korea University Ansan Hospital, Chungnam National University Hospital, and Yonsei Severance Hospital.

They announced that production of the second batch of plasma therapeutics for clinical trials will begin from today, and supply of the therapeutics is expected to be completed by mid-October.

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