CHA has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of malignant glioma. The designation was awarded on March 15, 2026, with Sichuan Jiuzhang Biotech. serving as the sponsor.

It should be noted that this orphan drug designation only qualifies the compound for relevant development incentives for rare disease therapies. At present, CHA has not yet obtained FDA marketing approval for this orphan indication.

Orphan Drug Designation supports the research and development of therapies for rare conditions with limited treatment options. This milestone highlights the potential value of chlorogenic acid in developing new therapeutic approaches for malignant glioma, a serious and hard-to-treat brain tumor. Further clinical investigations will be required to verify its safety and efficacy before official FDA approval.

This record can be verified on the official FDA Orphan Drug Database:

https://www.accessdata.fda.gov/scripts/opdlisting/oopd/listResult.cfm