Blonanserin

As a chronic disabling psychiatric disorder, schizophrenia is currently treated with typical antipsychotics that often have side effects such as extrapyramidal reactions and metabolic disorders, which greatly affect the medication compliance of patients. Blonanserin is a second-generation atypical antipsychotic drug with high affinity for dopamine D2, D3 receptors and serotonin 2A receptors. It exerts antipsychotic effects by regulating the balance of central neurotransmitters. It can not only effectively improve the positive symptoms of schizophrenia, but also outperform some traditional antipsychotics in improving negative symptoms and cognitive function impairment, with a lower incidence of adverse reactions, making it suitable for long-term maintenance treatment of adult patients with schizophrenia.

At present, the global market size of antipsychotic drugs has exceeded 40 billion US dollars, among which second-generation atypical antipsychotics account for more than 80%. Blonanserin maintains rapid growth in the Asian market by virtue of its better safety, with a compound annual growth rate of approximately 7.2% in the past five years. In terms of the domestic market, this product has been included in the National Medical Insurance Catalogue (Class B). At present, 4 domestic enterprises have obtained approval for generic preparations, and the market share of the original research drug is declining year by year. With the improvement of clinical awareness, it is expected that the overall domestic market size will exceed 300 million yuan in 2026.

The original research enterprise of blonanserin is Sumitomo Pharma of Japan, and the original research brand name is "Loxonin". The core compound patent of blonanserin expires in 2021 in major markets such as Japan and the United States, and the compound patent in China expires in 2019. The dosage form approved for the original research drug is tablet, with specifications of 4 mg and 8 mg, which has been included in the China Listed Medicines Catalogue as the reference listed drug. In terms of domestic API registration, there are currently 8 API registration numbers including that of Sumitomo Pharma, among which 6 are in A status, which can be associated with 14 blonanserin preparation varieties approved for marketing in China. (Data as of August 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of blonanserin impurity reference standards, which fully cover the research needs of process impurities, degradation impurities, etc. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. Meanwhile, all reference standards meet the requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can help enterprises efficiently complete the quality research and declaration work of APIs and preparations.