MFDS Rejects Celma Therapeutics' Phase 3 Clinical Trial Plan Amid Delisting Risk

[Asia Economy Reporter Song Seung-seop] The clinical trial plan for the COVID-19 treatment developed by Cellma Therapeutics, which gained attention for promoting the domestic contract manufacturing of the Russian COVID-19 vaccine, has been halted. This follows the Ministry of Food and Drug Safety's rejection of the Phase 3 clinical trial plan for Neovir injection submitted by Cellma Therapeutics last October.

According to industry sources on the 12th, the Ministry of Food and Drug Safety recently rejected the multinational Phase 3 clinical trial plan submitted by Cellma Therapeutics to evaluate the efficacy and safety of the antiviral drug 'Neovir injection' in patients with severe COVID-19.

Neovir injection is an antiviral drug developed by Russia's Pharmsintez, used for shingles, hepatitis B, AIDS, and other conditions. Cellma Therapeutics had planned to complete the multinational Phase 3 clinical trial repurposing Neovir injection as a COVID-19 treatment and then co-market it with Pharmsintez.

The clinical trial plan was rejected because it did not comply with certain parts of the 'Regulations on Approval of Clinical Trial Plans for Pharmaceuticals.'

Cellma Therapeutics attracted attention by promoting the domestic contract manufacturing of Russia's self-developed COVID-19 vaccine 'Covivac,' but last month, it received a 'disclaimer of opinion' in its 2020 fiscal year audit report, putting it at risk of delisting.

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