Telcon RF Pharmaceutical Applies for IND Approval for Bridge Clinical Trial of COVID-19 Treatment
[Asia Economy Reporter Minji Lee] Telcon RF Pharmaceutical announced on the 25th that it has applied to the Ministry of Food and Drug Safety for approval of an Investigational New Drug (IND) application for a bridging clinical trial of the novel coronavirus disease (COVID-19) treatment Lenzilumab.
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The company explained, "Through a Phase 1 clinical trial, we will verify the safety for Koreans, and based on the results of the U.S. Phase 3 clinical trial of Lenzilumab, we plan to apply for domestic import approval without a separate domestic clinical trial upon U.S. Emergency Use Authorization (EUA)."
This content was produced with the assistance of AI translation services.
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