China's CNS Drug Sector Sees Approval Boom in 2026

　　【Pharmaceutical Network Industry DynamicsSince 2026, pharmaceutical companies in China have reaped substantial rewards in new drug development within the psychiatry/neurology (CNS) field. Several innovative drugs have made critical progress in areas such as schizophrenia, depression, and Alzheimer's disease, including...Active Pharmaceutical Ingredients (API)/ The listing of formulations and the clinical approval of Class 1 new drugs are also obtained, and the R&D pipeline is becoming increasingly enriched.
 

Recently, KHN707 Tablets, a Class 1 new chemical drug applied for by Kanghong Pharmaceutical, has been granted clinical trial approval by the Center for Drug Evaluation (CDE) of the National Medical Products Administration, with the indication for insomnia.
 

This is an orally administered small-molecule selective orexin receptor (OX2R) antagonist independently developed by Kanghong Pharmaceutical. It has demonstrated sleep-promoting effects in various preclinical insomnia efficacy models. Notably, the clinical trials for KH607 tablets, a Class 1 new drug by Kanghong Pharmaceutical for treating depression and postpartum depression, as well as KHN702 tablets, another Class 1 new drug for acute pain treatment, are also proceeding steadily.
 

On February 14, the National Medical Products Administration (NMPA) of China announced that the Obinutuzumab β Injection, developed by Beijing Tian Guangshi, has been officially approved for marketing. It is indicated for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are positive for aquaporin-4 (AQP4) antibodies.
 

On January 19, Livzon Pharmaceutical announced that the clinical trial application for its Brexpiprazole Microspheres for Injection for the treatment of schizophrenia has recently been officially accepted by the National Medical Products Administration.
 

On January 14, XtalPi announced that RTX-117, an innovative drug pipeline from its incubated company ReviR Therapeutics, had recently achieved dual IND approvals in both China and the U.S. RTX-117 is China's first innovative Class 1 drug pipeline targeting CMT and represents a deep collaboration between ReviR and XtalPi, leveraging AI+.RobotThe first project in a series of rare disease drug pipelines to enter clinical trials.
 

January 8 News: Luye Pharma announced that the Center for Drug Evaluation of the National Medical Products Administration of China has officially accepted the new indication application for market approval of Class 1 innovative drug Roxilitine (Toludesvenlafaxine Hydrochloride Sustained-Release Tablets), intended for the treatment of Generalized Anxiety Disorder (GAD).
 

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"Mental illness" refers to a range of mental and behavioral disorders, mainly including depression, bipolar disorder, schizophrenia, anxiety disorders, as well as developmental and behavioral disorders that typically begin in childhood and adolescence. In recent years, with the acceleration of population aging and the trend of mental illness becoming more prevalent among younger individuals, the market for nervous system medications has been continuously growing. According to incomplete statistics, from Q1 to Q3 of 2025, the sales of nervous system drugs in key provinces' physical pharmacies in China were nearly 7 billion yuan.
 

The continuous expansion of the market is constantly attracting domestic pharmaceutical companies to make strategic investments. Industry experts believe that since 2026, China's CNS (Central Nervous System) drug research and development has shown a positive trend characterized by breakthroughs in fundamental research, a rich clinical pipeline, and the emergence of differentiated innovations, reflecting an acceleration in the development and breakthroughs of China's CNS drug research. In the future, from developing long-acting formulations to address compliance challenges, to exploring new mechanism drugs for "efficacy-side effect separation," and further to AI-driven rare disease drug discovery, Chinese pharmaceutical companies will rapidly progress from following innovation to pioneering original innovation, providing more treatment options for patients.
 

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