Kelun Pharmaceutical gets NMPA approval for paliperidone palmitate injection

Sichuan Kelun Pharmaceutical Co., Ltd. announced today that its subsidiary, Hunan Kelun Pharmaceutical Co., Ltd., has received drug registration approval from the National Medical Products Administration (NMPA) for its paliperidone palmitate injection. This Class 4 chemical medicine is available in three strengths: 0.75ml: 75mg, 1.0ml: 100mg, and 1.5ml: 150mg.

Paliperidone palmitate injection, originally developed by Janssen Pharmaceutica, was first approved in the US in 2009. This long-acting atypical antipsychotic is administered monthly for the acute and maintenance treatment of schizophrenia, offering advantages such as improved patient adherence and reduced relapse risk. Global sales for this drug were approximately $3.5 bn in 2024.

This approval marks the first product from Kelun Pharmaceutical's proprietary long-acting microcrystal injection platform, which uses an innovative warm-pressure treatment process. This approval is expected to enhance Kelun Pharmaceutical's competitive position in the central nervous system therapeutic area.