Brexpiprazole: A Multi-Billion-Dollar Antipsychotic Attracting Intense Interest from Chinese Pharma Companies

　　【Pharmaceutical Network Industry DynamicsRecently, the antipsychotic drug Brexpiprazole Tablets (specifications: 2mg and 1mg) independently developed by Zhenbao Island has received the acceptance notice from the Center for Drug Evaluation of the National Medical Products Administration (acceptance numbers: CYHS2402315, CYHS2402317). The marketing authorization application of this drug has been accepted, which will further enrich the company's product pipeline, broaden market sales channels, and enhance market competitiveness.
 

Data show that brexpiprazole is a third-generation antipsychotic drug, originally developed by Otsuka and Lundbeck. It is an atypical antipsychotic small-molecule drug that modulates serotonin-dopamine activity across various receptors.
 

Brexpiprazole was approved by the FDA for marketing in the United States in 2015 for the treatment of major depressive disorder (MDD) and schizophrenia. In 2016, it was approved for maintenance treatment in adult patients with schizophrenia, and in 2018, it was successively approved for marketing in Japan and the United States. In 2021, the FDA approved a supplemental New Drug Application (sNDA) for brexpiprazole for the treatment of schizophrenia in pediatric patients aged 13 to 17. In May 2023, the FDA announced the approval of an expanded indication for brexpiprazole to treat agitation associated with dementia caused by Alzheimer's disease. In China, the original drug brexpiprazole tablets were approved for marketing in June 2024 for the treatment of schizophrenia.
 

It is reported that since its launch, the global sales of Brexpiprazole have achieved rapid year-on-year growth. Relevant data statistics show that the drug's global sales exceeded 2.2 billion US dollars in 2023, with a year-on-year increase of 10%.
 

In China, mental illness has become a serious public health and social problem. According to data from the Disease Prevention and Control Bureau of the National Health Commission, as of the end of 2017, the number of psychiatric patients in China had exceeded 200 million. In recent years, the high incidence of depression, schizophrenia, and other mental illnesses has led to an increasing number of patients facing significant unmet treatment needs.
 

Currently, targeting a considerable market space, a large number of pharmaceutical companies in China are vying to make their moves. Apart from Zhenbao Island, several other local pharmaceutical companies have also made new progress in the development of Brexpiprazole recently.
 

For example, on July 19, the website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that Qilu Pharmaceutical's antipsychotic drug Brexpiprazole Oral Soluble Film had been submitted for marketing approval and accepted. This submission by Qilu is for a new dosage form classified as Type 2.2 oral soluble film. Compared with tablets, the oral soluble film has advantages such as ease of use, no need to be taken with water, and rapid dissolution when placed on the tongue. It is suitable for children, elderly patients, and those with swallowing difficulties, improving patient compliance.
 

On July 10, according to the CDE website, the marketing application for Brexpiprazole Tablets, a Category 4 generic drug submitted by Hunan Kelun Pharmaceutical, a subsidiary of Kelun, was accepted. In addition to the tablets, Kelun also filed an application for Brexpiprazole Long-acting Injection, a Category 2.2 modified new drug, last year. In October 2023, it received the "Drug Clinical Trial Approval Notice" for "Brexpiprazole Long-acting Injection." On March 22, the company replied to investors on an interactive platform, stating that it is proceeding with the clinical development of this project as planned.
 

At the same time, China-produced Brexpiprazole is also accelerating its global outreach. On March 23, Huahai Pharmaceutical announced that it recently received a notification from the U.S. Food and Drug Administration (FDA) stating that the Abbreviated New Drug Application (ANDA) for Brexpiprazole Tablets submitted by the company to the U.S. FDA has been granted tentative approval. The receipt of this tentative approval from the U.S. FDA indicates that the product has met all the review requirements for generic drugs. The company stated that obtaining the tentative approval for Brexpiprazole Tablets from the U.S. FDA will help strengthen the product supply chain, diversify the product portfolio, enhance the market competitiveness of the company's products, and bring positive impact to the company’s expansion into the U.S. market.
 

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