Qilu Pharmaceutical's Brexpiprazole Orally Disintegrating Film Receives First Domestic Approval

On March 13, the official website of the National Medical Products Administration (NMPA) showed that the 2.2 class new drug Brexpiprazole Oral Soluble Film developed by Qilu Pharmaceutical Co., Ltd. has been approved for marketing. This is the first such drug to be approved for marketing in China.Brexpiprazole Orally Disintegrating Film.

Brexpiprazole is an atypical antipsychotic small molecule drug that can partially agonize serotonin receptor 1A and dopamine receptor D2, and target to antagonize serotonin receptor 2A, thereby regulating serotonin and dopamine levels to play a therapeutic role in psychosis.

The original research company of Brexpiprazole is Otsuka. In November 2011, Lundbeck reached a cooperation agreement with Otsuka and obtained the rights to Brexpiprazole in most Asian countries (such as Japan, Turkey, and Egypt).

In July 2015, brexpiprazole was first approved for marketing in the United States under the trade name Rexulti, for the treatment of major depressive disorder (MDD) or schizophrenia. In May 2023, the indications for brexpiprazole were expanded to include agitation symptoms in Alzheimer's disease. In June 2024, brexpiprazole was approved for marketing in China. According to the financial reports of Lundbeck and Otsuka Pharmaceutical,Brexpiprazole Sales Reach $2.24 Billion in 2025 (+13%)。

Except forQilu Pharmaceutical, 10 companies in China have submittedMarketing Application for Brexpiprazole Oral Soluble Film, includingKelun Pharmaceutical、Xinfeng Pharmaceutical,BociMed and other enterprises。

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