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First China-Made FDA-Approved Drug

Oct. 7, 2015

On October 7, 2015 Luye Pharma Group announced that the US FDA has confirmed the Company’s New Drug Application submission in the U.S. for an investigational drug product of Risperidone Extended-Release Microspheres for Injection (‘‘LY03004’’) without additional clinical trials.

Luye believes that LY03004 as an injectable drug can improve medication compliance in patients with schizophrenia, which is a common issue with oral antipsychotic drugs and would simplify treatment regimen since it needs to be injected only once every two weeks. Furthermore, LY03004 has several advantages over another marketed drug: There is, for example, no need to administer oral formulation during the three weeks after the first injection of LY03004 as is the case with the marketed drug. A stable plasma drug level can be reached much faster with LY03004 as compared to the marketed drug.