Hainan Huluwa Pharmaceuticals Receives NMPA Notification for Brexpiprazole Orally Disintegrating Film

Apr 28, 2026 09:38 CST Updated 09:38

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

Kelun

Innovative Pharmaceutical R&D Company

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Issued by the National Medical Products Administration2026Year04Month22Notice of Drug Delivery Information in Japan, wherein,Hainan Huluwa Pharmaceutical's Application for Brexpiprazole Oral Soluble Film Receives Notification。

Brexpiprazole, an atypical antipsychotic drug originally developed by China OTSUKA Pharmaceutical Co., Ltd., regulates neurotransmitter levels through partial agonism and antagonism of serotonin and dopamine receptors. It is used to treat mental illnesses such as schizophrenia and major depressive disorder. After being approved in the United States in July 2015, its indications have expanded to include agitation symptoms in Alzheimer's disease, and it was approved for marketing in China in June 2024.

According to the financial reports released by Lundbeck and Otsuka, the global sales of Brexpiprazole reached $2.224 billion in 2025.

Brexpiprazole Oral Soluble Film, compared with tablets, is convenient to take without water, dissolves in the mouth within seconds, and significantly improves medication compliance and convenience. It is especially suitable for patients with swallowing difficulties, offering clear clinical advantages and market value.

This year3Month13Recently, Qilu Pharmaceutical Co., Ltd. developed2.2A New Drug, Brexpiprazole Oral Soluble Film, Has Been Approved for Marketing in China, Becoming the First Brexpiprazole Oral Soluble Film to Be Approved in the Country.3Month20Date, Kelun Pharmaceutical'sBrexpiprazole Oral Soluble Film Approved for Marketing, as the Second One.

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