CSPC Pharma Gains NMPA Approval for Once-Monthly Paliperidone Palmitate Injection to Treat Schizophrenia

Bulletin Express07-24 19:21

CSPC Pharmaceutical Group Limited (CSPC Pharma) has secured marketing authorisation from China’s National Medical Products Administration (NMPA) for its self-developed Paliperidone Palmitate Injection, a second-generation long-acting antipsychotic designed for both acute and maintenance treatment of schizophrenia.

The product will be available in three dosage strengths—0.75 ml: 75 mg, 1.0 ml: 100 mg and 1.5 ml: 150 mg (all calculated as C23H27FN4O3). Administered once monthly, the injection delivers rapid therapeutic onset without requiring supplemental oral medication, positioning it as a practical option for stabilising acute episodes while supporting long-term disease management.

Clinical and guideline support underscores the therapy’s relevance: the Chinese Guidelines for the Prevention and Treatment of Schizophrenia (2025 Edition) and other international protocols list once-monthly paliperidone palmitate among recommended treatments, particularly for patients with poor adherence and elevated relapse risk. Improved compliance from the extended dosing interval is expected to reduce missed doses, relapse rates and rehospitalisations, bolstering its pharmacoeconomic appeal.

With this approval, CSPC Pharma expands its psychiatric and neurological portfolio, reinforcing its strategic focus on high-value, innovative therapeutics.

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