China-based Luye Pharma Group (HKG: 2186) has announced receiving clinical trial approval in Europe for its paliperidone palmitate extended-release injectable suspension (LY03010). This approval marks a significant step forward in the development of this second-generation antipsychotic drug, which is designed for the treatment of schizophrenia and schizoaffective disorders.
Paliperidone Palmitate: Drug Profile
Paliperidone palmitate is a second-generation antipsychotic suitable for a single monthly dosage by intramuscular injection. It is indicated for the treatment of schizophrenia and schizoaffective disorders. Developed via the 2001/83/EC modified drug pathway, LY03010 is equivalent to the reference drug Xeplion, sharing the same administration route and indication.
Upcoming Clinical Study Design
An imminent randomized, open, single-dosing, Xeplion parallel-controlled study is designed to assess the relative bioavailability of LY03010 and Xeplion after a single administration. This study will provide crucial data on the drug’s performance and safety profile. Previously, LY03010 reached an anticipated endpoint in a pivotal study in the US, where Luye Pharma plans to make a market filing for the drug. The drug is also awaiting regulatory decisions in China.
Market and Therapeutic Context
Long-acting antipsychotic injections and long-acting paliperidone palmitate injections generated respective global sales of USD 7.1 billion and USD 4.24 billion in 2021. Luye Pharma’s risperidone microsphere injection (LY03004), another long-acting therapy for schizophrenia, has been approved for marketing in China and the US. This approval highlights Luye Pharma’s commitment to developing innovative treatments for psychiatric disorders and expanding its market presence in the global pharmaceutical sector.
Strategic Implications
The clinical trial approval for LY03010 in Europe is a strategic milestone for Luye Pharma Group. It underscores the company’s dedication to advancing its pipeline of innovative therapies and enhancing patient access to effective treatments for schizophrenia and related disorders. By conducting clinical trials in Europe, Luye Pharma aims to further validate the safety and efficacy of LY03010, positioning the drug for potential global market approval and commercialization.-Fineline Info & Tech
