YuanDong Bio Secures China's First Generic Approval for Brexpiprazole, a $2B Antipsychotic Blockbuster

　　【Pharmaceutical Network Product InformationRecently, a significant update has emerged in China's psychiatric medication sector — the first generic version of the popular drug Brexpiprazole Tablets has been officially approved. Chengdu Yudong Biotech successfully broke through the competition from Qilu Pharmaceutical, Kelun, and other companies to become the first company to produce the generic version.
 

On December 9, Yuandong Bio announced that the company had recently received the "Drug Registration Certificate" issued by the National Medical Products Administration. The drug name is Brexpiprazole Tablets, with specifications of 1mg, 2mg, and 4mg, and the registration classification is Category 4 chemical drug. After the approval of this drug, it is deemed to have passed the consistency evaluation, making it the first domestically produced generic drug approved under the new registration classification in China. Currently, only the original research company, China OTSUKA Pharmaceutical Co., Ltd., is selling Brexpiprazole Tablets in China, with sales amounting to approximately 160,000 yuan in the first half of 2025.
 

It is reported that after China OTSUKA Pharmaceutical Co., Ltd.'s Brexpiprazole enters the Chinese market in 2024, it will not be included in the medical insurance system for two years, and there also seems to be no current plan to launch the 4mg specification in China, leaving market space for generic drugs.
 

Brexpiprazole Tablets, specifically designed for the treatment of schizophrenia, demonstrate clinical advantages in precise receptor mechanisms, low risk of side effects, broad indications coverage, and economic accessibility. These features make it particularly suitable for patient groups requiring long-term treatment and being sensitive to side effects. Schizophrenia is a severe mental illness, and as of 2020, the number of schizophrenia patients in China reached 5.3212 million, indicating an urgent demand for drug therapies. Data shows that global sales of brexpiprazole have continued to rise in recent years, with a year-on-year increase of 22.68% in 2023, surpassing 2 billion US dollars.
 

This variety has attracted significant attention from pharmaceutical companies in China. It is reported that only ten days after the original drug was launched, a generic version submitted an application for marketing approval. Qilu Pharmaceutical, Kelun, and many other pharmaceutical companies are actively positioning themselves. Among them, Kelun was the first company to submit an application for marketing approval.
 

Encouragingly, Yuandong Biotech has become the first company to pass the evaluation in China. It is the first domestic company to complete the bioequivalence (BE) trial for Brexpiprazole Tablets and was also an early player in this field. However, industry experts point out that Yuandong Biotech's exclusive advantage will not last long, as 39 companies have already submitted their applications for market entry. A price war and competition over generic drugs are about to unfold.
 

Public information shows that Yuandong Biotech is a company driven by R&D innovation, integrating chemical...Active Pharmaceutical IngredientsA biopharmaceutical enterprise integrating the research and development, production, and sales of high-end chemical drugs and biologics. In the first three quarters, Yundong Biotech continued to invest substantial funds in R&D to expand its product pipeline. During the first three quarters of this year, the company's R&D investment reached 195 million yuan, accounting for 19.10% of its operating revenue. Meanwhile, Yundong Biotech actively expanded into the innovative drug sector through strategic investments.
 

The third-quarter report shows that in the first three quarters of this year, Yuandong Bio has received approval for 15 high-end formulation products. These include Ephedrine Hydrochloride Injection managed as a Class I psychotropic drug, Oxazepam Tablets and Nalfurafine Hydrochloride Orally Disintegrating Tablets classified as Class II psychotropic drugs, Baclofen Hydrochloride Tablets—the first muscle relaxant to pass evaluation and be marketed, Perindopril Amlodipine Tablets for compound hypertension treatment, and Dacomitinib Tablets used as a first-line treatment for lung cancer.
 

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