The U.S. Food & Drug Administration declined to approve two China-tested cancer treatments on Monday, saying one of the companies – Hutchmed Ltd. – needs to test its drug for the U.S. population in a diverse multi-regional trial.

Junshi Biosciences, based in Shanghai, China, announced that an Independent Monitoring Committee (IDMC) decided the company’s Phase III JUPITER-02 trial had met the pre-specified primary endpoint at the interim analysis.