Recently, Jiudian Hongyang's API Lurasidone Hydrochloride (Y20220000780) officially obtained the marketing approval from the CDE, and its registration status was successfully transferred to "A".

Lurasidone hydrochloride is a new antipsychotic drug with dual effects. It has a high affinity for 5-HT2A receptors and dopamine D2 receptors. It is clinically used for depressive episodes of schizophrenia and bipolar I disorder, and has significant therapeutic effects on both positive and negative symptoms of patients with mental illness. Lurasidone hydrochloride is a second-generation antipsychotic drug with a unique mechanism of action. Compared with other antipsychotic drugs, it has the advantages of high safety, few side effects, and a wide range of indications.

According to WHO statistics, more than 23 million people worldwide suffer from schizophrenia in 2023, and this number is still growing year by year at a certain rate. The global sales of lurasidone hydrochloride in 2020 were $1.946 billion, and the global sales in 2021 exceeded the $2 billion mark. With its good efficacy, safety and tolerability, lurasidone hydrochloride has became one of the first choice drugs for the treatment of schizophrenia and bipolar depression. In China, the incidence of schizophrenia has also increased year by year. According to statistics, the number of schizophrenia patients in 2023 has reached 7.8 million, and the market demand is huge. Lurasidone hydrochloride tablets were approved for listing by China's National Medical Products Administration in 2019 and were officially included in Chinese national medical insurance catalog in March 2021. In 2023，the sales of lurasidone hydrochloride preparations in China were about 120 million yuan. So far, 15 domestic companies have approved generic drugs for listing, and competition in the lurasidone hydrochloride market will intensify in the future.

Jiudian Hongyang's neurological drugs that have obtained marketing authorization in CDE include ziprasidone hydrochloride, sumatriptan succinate, trazodone hydrochloride, and pramipexole hydrochloride. The approval of lurasidone hydrochloride has further expanded the product line of Hongyang's nervous system drugs and further enhanced the company's core competitiveness. In the future, Jiudian Hongyang will continue to adhere to innovative cooperation and smart research and development to provide customers with more high-quality products and services.