On June 22, the official website of the National Medical Products Administration (NMPA) showed that seven products received notification documents, among whichYangtze River Pharmaceutical Nanjing Hailing PharmaceuticalofBrexpiprazole TabletsAs listed. Data from PharmCube shows that this product’s initial marketing application, filed in May 2025, was not approved, marking its second setback. According to industry practice, the issuance of a notification letter typically indicates either a “non-approval” decision on the marketing application or the applicant’s voluntary withdrawal following communication or preliminary assessment.

Screenshot source: NMPA official website

Brexpiprazole（Brexpiprazole）is an atypical antipsychotic drug, manufactured byH. Lundbeck A/SandOtsuka Pharmaceutical JapanJointly developed for the treatment of major depressive disorder, schizophrenia, and other conditions. Data from PharmCube shows that in 2025BrexpiprazoleGlobal sales exceeded $900 million, representing a year-on-year increase of 10.31%.

Currently, the brexpiprazole formulations approved in China include tablets, orally disintegrating tablets, and oral dissolving films, with 18 pharmaceutical companies holding production approvals. Among them,Brexpiprazole TabletsA total of 14 companies, including Yuandong Biology, Qilu Pharmaceutical, and Hunan Kelun Pharmaceutical, have passed the consistency evaluation.

Otsuka Pharmaceutical’s original brexpiprazole tablets were launched in the Chinese market on June 28, 2024. Just two weeks later, on July 10, Kelun Pharmaceutical submitted an application for marketing approval of its generic version, with domestic pharmaceutical companies quickly following suit. In December 2025, Chengdu Yuandong Bio-Pharmaceutical secured approval for the first generic brexpiprazole tablets in China. To date, more than 30 companies have filed applications for both tablet and orally disintegrating tablet formulations, all of which are currently under regulatory review and approval.

Regarding the orally disintegrating tablet formulation, Kelun was the first to file an application, followed by the acceptance of submissions from nine other companies, including Qilu Pharmaceutical, Hekang, Nanjing Haina, and Chengdu Kanghong. Notably, Qilu Pharmaceutical submitted its application on July 18, 2024, and successfully received approval on January 30, 2026, securing the status of the first domestic generic for this formulation and gaining a competitive edge through differentiation.

The core compound patent for brexpiprazole is expected to expire in April 2026, at which point market competition will intensify further.

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