Domestic Psychiatric Drug R&D Accelerates as Multiple Chinese Pharma Companies Report Breakthroughs and File IPOs

　　【Pharmaceutical Network Industry DynamicsIn recent years, with the increase in social pressure and the growing attention to mental health, the demand for psychiatric drugs in the market has been continuously increasing. Moreover, advancements in drug research and development technology have significantly improved the efficacy and safety of new drugs, further promoting the widespread adoption and application of psychiatric drugs worldwide.
 

It is reported that, by 2025, pharmaceutical companies in China have achieved fruitful results in the field of psychotropic drug research and development. Recently, several new drugs have made breakthroughs in clinical trials, and some have even been launched on the market.
 

On November 24, it was reported that Luye Pharma's independently developed new-generation 5-hydroxytryptamine 2A receptor (5-HT2AR) inverse agonist and 5-hydroxytryptamine 2C receptor (5-HT2CR) antagonist LY03017 has received approval from the U.S. Food and Drug Administration (FDA) to commence clinical trials.
 

LY03017 is an innovative drug in the field of central nervous system therapy being developed simultaneously in China and the United States. It is intended for the treatment of Alzheimer's disease psychosis (ADP), Parkinson's disease psychosis (PDP), and negative symptoms of schizophrenia (NSS). Currently, LY03017 has entered Phase I clinical trials in China.
 

On November 14, the paliperidone palmitate injection of Hunan Kelun Pharmaceutical Co., Ltd. was officially approved for marketing by NMPA. This drug is a once-a-month long-acting antipsychotic injection used for the full-course treatment of schizophrenia. Data shows that paliperidone palmitate injection is a prodrug of paliperidone, a second-generation antipsychotic. The original research company is Janssen Pharmaceuticals under Johnson & Johnson, which entered China in 2011. This drug only needs to be administered once a month, significantly improving patient compliance, reducing the risk of relapse and frequency of hospitalization. It is recommended by multiple countries for both acute and maintenance treatment of schizophrenia.
 

Data shows that the global sales of this product have exceeded 30 billion yuan in 2024, increasing by 4% year-on-year. In the future, after Hunan Kelun Pharmaceutical Co., Ltd.'s product is launched, it will jointly impact the original drug market with the generic drugs from Qilu Pharmaceutical and Luye Pharmaceutical.
 

On November 10, Qilu Pharmaceutical's Entacapone/Sinemet Tablets (II) (Shenkean®) received marketing approval from the National Medical Products Administration (NMPA) for the treatment of adult patients with Parkinson's disease who experience or are accompanied by "end-of-dose" motor fluctuations that are not adequately controlled by Levodopa/Carbidopa (DDC) inhibitor therapy.
 

Entacapone, Levodopa, and Carbidopa Tablets is a new compound formulation for the treatment of Parkinson's disease, containing entacapone, levodopa, and carbidopa. In 2024, the sales revenue of this drug in the Chinese hospital market increased by 17% year-on-year.
 

On the same day, Jinghua Pharmaceutical Group CO.,LTD. received two "Drug Registration Certificates" for Carbidopa and Levodopa Sustained-Release Tablets issued by the National Medical Products Administration; the large specification product (Carbidopa 50mg/Levodopa 200mg) is the third approved enterprise in China, and the small specification product (Carbidopa 25mg/Levodopa 100mg) is the first domestically produced generic product by Jinghua Pharmaceutical Group CO.,LTD.
 

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Overall, the current market for psychiatric drugs in China is in a phase of rapid expansion, with vast market potential. Against this backdrop, Chinese pharmaceutical companies are increasingly competitive in this market by leveraging generic drugs to achieve import substitution and making gradual breakthroughs with innovative drugs. The overall development momentum of the industry is expected to remain strong in the future.
 

　　Disclaimer: In no event shall the information or opinions expressed in this article constitute investment advice to any person.