China-based Luye Pharma Group (HKG: 2186) has announced that the market filing for its paliperidone palmitate extended-release injectable suspension (LY03010) has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is the treatment of acute and maintenance schizophrenia, with no similar product currently approved for marketing in China.
Clinical Study and Regulatory Progress
A pivotal clinical study for LY03010 has recently reached expected endpoints, paving the way for a New Drug Application (NDA) filing via the 505 (b)(2) channel in the US. This marks a significant step forward in the global development of LY03010, highlighting Luye Pharma’s commitment to addressing significant unmet medical needs in schizophrenia treatment.
Drug Profile and Patient Benefits
Paliperidone palmitate is a second-generation antipsychotic drug suitable for single monthly dosage by intramuscular injection. It is indicated for the treatment of schizophrenia and schizoaffective disorders. The drug can improve compliance issues that often affect oral antipsychotic drugs in patients with schizophrenia, including by optimizing the initial dosing regimen. This innovative approach aims to enhance patient outcomes and quality of life.-Fineline Info & Tech
