Domestic Sleep Aid Breakthrough: Coastal Pharma's Class 1 Innovative Drug Fazanleisen Approved!

　　【Pharmaceutical Network Enterprise News】 Sleep health is crucial to the physical and mental well-being and quality of life of the entire population. In recent years, with the increasing pace and pressure of modern society, insomnia disorders have become a highly prevalent chronic condition, troubling a vast number of people over the long term. Statistics show that the incidence of insomnia among Chinese adults is as high as 38.2%, with nearly 300 million Chinese suffering from sleep disorders, indicating an extremely large patient population. Currently, driven by this enormous market, many pharmaceutical companies have started to accelerate innovation in this field and have successively achieved breakthroughs.
 

Recently, the National Medical Products Administration approved the marketing of Fazanorex Tablets (trade name: Mengping), a Class 1 innovative drug submitted by Jiangsu Hai'an Pharmaceutical Co., Ltd., for the treatment of adult insomnia patients characterized by difficulty in falling asleep and/or maintaining sleep. This approval was based on the positive results of a multi-center, randomized, double-blind, placebo-controlled Phase III clinical trial, which aimed to evaluate the efficacy and safety of Fazanorex.
 

Public data shows that Fazanerest is a potent dual antagonist of orexin type 1 and type 2 receptors (OX1R and OX2R), improving sleep by inhibiting orexin receptors, including accelerating sleep onset and prolonging sleep duration. The drug was first submitted for marketing approval in January 2025.
 

According to reports, Yangtze River Pharmaceutical Group has currently built up a "Western medicine + Traditional Chinese Medicine + Comprehensive Health" collaborative layout in the sleep health field, centered on self-developed innovative drugs, covering different levels of sleep needs. The next step will be to accelerate large-scale production and market supply, while continuously increasing R&D investment in sleep medicine. They will keep enriching the innovative drug pipeline around insomnia and other sleep disorders, benefiting the world with more locally developed innovations.
 

Notably, apart from YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU JOINT STOCK CO., LTD, multiple Chinese pharmaceutical companies are also set to achieve breakthroughs in the field of insomnia treatment drugs by 2026. For instance, in April, Hansoh Pharma presented the Phase Ib/II research data of its self-developed selective OX2R antagonist HS-10506 at the annual meeting of the American Academy of Neurology (AAN). Subsequently, a Phase III clinical trial was registered in China to evaluate the efficacy and safety of its novel drug HS-10506 in Chinese adult patients with insomnia disorder.
 

It is reported that HS-10506, a selective orexin-2 receptor (OX2R) antagonist currently in clinical development for the treatment of sleep disorders, has shown promising results. Data from Phase Ib/II studies indicate that selective OX2R inhibition may preserve sleep-promoting effects while further reducing off-target effects. Additionally, the drug demonstrated consistent improvements across various objective and subjective sleep measurement metrics, with no adverse effects observed on alertness, cognitive function, depression, or anxiety symptoms following treatment.
 

On January 10, the CDE website showed that the marketing application for Ramelteon Tablets by Nanjing Chia Tai Tian Qing Pharmaceutical was accepted. Ramelteon is a melatonin receptor agonist used clinically to treat insomnia, primarily for insomnia characterized by difficulty falling asleep, and it also has proven efficacy in treating chronic and short-term insomnia. Currently, more than 10 pharmaceutical companies in China have obtained clinical approval for Ramelteon Tablets.
 

The industry believes that from the approval of Fazanerest, to the release of clinical data for HS-10506, as well as the marketing application of Ramelteon, all fully reflect that China's sleep improvement drug sector has ushered in a wave of breakthroughs with domestically produced innovative drugs. In the future, driven by accelerated innovation in the industry constantly pushing products to market, more and more domestically produced innovative drugs will emerge, providing safer, more effective, and accessible treatment options for the vast number of patients suffering from insomnia.
 

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