Luye Pharma Group (02186) said it has completed a clinical study for risperidone extended release microspheres for injection, an investigational drug product of risperidone (LY03004) in the US.
It said 16 patients with schizophrenia and/or schizoaffective disorders were enrolled for this clinical study at two study sites with significant experiences in the US. The results demonstrated similar pharmacokinetic profiles in terms of peak and total plasma drug levels between LY03004 and the marketed drug (marketed product in the same dosage form).
Furthermore, the company is currently conducting a pivotal study for LY03004 project with multiple injections. It expects that after completion of the pivotal study, the company may submit a new drug application with the US Food and Drug Administration.
It is targeting to obtain regulatory approval for LY03004 in the US and Europe and it believes that the results of this clinical study represents an important progress in the right direction.
The board of the company believes that LY03004 has promising market prospects in the
international market.
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