[ET Net News Agency, 26 September 2018] Luye Pharma (02186) said the clinical trial
application for the group's new product candidate, Paliperidone Palmitate injectable
suspension, for intramuscular use (LY03010), has obtained the approval from the United
States Food and Drug Administration (FDA) to initiate clinical trials for the treatment of
schizophrenia and schizoaffective disorder in the US.
LY03010 is an extended release injectable suspension which is used for the treatment of
schizophrenia and schizoaffective disorders by intramuscular injection, monthly dose.
LY03010 can improve the common medication compliance issue of oral antipsychotic drugs in
the patients with schizophrenia. Compared to another similar drug on the market, LY03010
optimizes the initial dosing regimen, therefore may bring greater convenience to patients
and hence increase patient compliance. The FDA has confirmed that it is acceptable to
demonstrate bioequivalence at steady state after multiple doses to support the 505(b)(2)
NDA submission for LY03010 in the Pre-IND meeting minutes. (SC)