Qilu Pharmaceutical Receives Approval for Two Generic Drugs Targeting Schizophrenia

On October 13, the official website of the National Medical Products Administration showed that two generic drugs of Qilu Pharmaceutical Co., Ltd., Lurasidone Hydrochloride Tablets and Paliperidone Palmitate Injection, were approved for marketing. The latter is the first generic version of Paliperidone Palmitate Injection to be approved in China, and this product is also the first domestically produced monthly long-acting microcrystal formulation approved in China.

Lurasidone, originally developed by Sumitomo Pharma, is an atypical (second-generation) antipsychotic drug. It exhibits a multi-receptor, multi-target mechanism of action, acting as a high-affinity antagonist for dopamine D2 receptors and serotonin 5-HT2A, 5-HT7 receptors, as well as a partial agonist for serotonin 5-HT1A receptors. The drug was approved for marketing in China in January 2019 for the treatment of schizophrenia.

Palmitate paliperidone is a prodrug of paliperidone, which forms a drug reservoir at the injection site after intramuscular injection, allowing for the slow release of the drug. This medication can simultaneously antagonize central dopamine 2 (D2) receptors and serotonin 2 (5HT2A) receptors, thereby producing a therapeutic effect on schizophrenia.

Paliperidone Palmitate Injection, as a new type of atypical antipsychotic long-acting microcrystalline drug, precisely controls the particle size distribution of the drug through nanogrinding technology, overcoming the time-lag barrier of drug release. Without the need for oral medication supplementation, it can be used for both acute and maintenance treatment of schizophrenia. Compared with traditional antipsychotic drugs, this product only requires once-monthly dosing, offering distinct advantages in terms of clinical convenience, preventing missed doses, effectively reducing relapse and rehospitalization rates, and alleviating the burden on families and society.

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