FDA Approves IND Submission Allowing ABVC BioPharma to Proceed With Clinical Study of ABV-1519 for Treatment of Non-Small Cell Lung Cancer

January 5, 2023

https://www.globenewswire.com/news-release/2023/01/05/2583737/0/en/FDA-Approves-IND-Submission-Allowing-ABVC-BioPharma-to-Proceed-With-Clinical-Study-of-ABV-1519-for-Treatment-of-Non-Small-Cell-Lung-Cancer.html

FREMONT, CA, Jan. 05, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ:ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology today announced that the US Food & Drug Administration notified the company that the IND application for the proposed clinical investigation of BLEX 404, the primary active ingredient in ABV-1519, for advanced inoperable or metastatic EGFR-mutated non-small cell lung cancer has been approved and the study can proceed. The treatment, which is being co-developed by BioKey, Inc., a wholly owned subsidiary of ABVC based in Fremont, California and by the Rgene Corporation was submitted to the FDA by Rgene on November 30, 2022.

Read more at globenewswire.com

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