China's Anti-Insomnia Therapeutics Achieve New Breakthrough: Hansoh Pharma Announces Positive Phase 1b/2 Data for Novel OX2R Antagonist HS-10506

　　【Pharmaceutical Network Product Information】When the silence of深夜 becomes a torment, and tossing and turning becomes the norm, insomnia is eroding the health of modern people at an alarming rate. According to the "2025 China Sleep Health Survey Report" released by the Chinese Sleep Research Society, approximately 48.5% of China's population aged 18 and above suffer from sleep disturbances. Over 300 million people experience sleep disorders, of which about 150 million require active intervention. Moreover, sleep disorders are showing a trend of affecting younger populations.
 

As insomnia becomes a common health challenge in modern society, pharmaceutical companies in China are increasingly focusing on the field of anti-insomnia drugs and gradually achieving breakthroughs. For instance, Hansoh Pharma announced on April 21, 2026, that it presented phase 1b/2 clinical trial data for HS-10506, an OX2R antagonist used to treat insomnia patients, at the 2026 American Academy of Neurology (AAN) Annual Meeting. HS-10506, a selective orexin-2 receptor (OX2R) antagonist developed by Hansoh Pharma, is intended for the treatment of sleep disorders. Studies have shown that HS-10506 demonstrates efficacy in improving sleep onset and maintenance, while also exhibiting good safety and pharmacokinetic profiles.
 

The study results showed that in Phase 2, compared with the placebo group, the mean changes from baseline in LPS (D13/14) for the HS-10506 20mg, 40mg, and 60mg groups were -13.7 minutes, -16.6 minutes, and -18.8 minutes, respectively, with significant differences that were clinically meaningful. HS-10506 also demonstrated consistent improvement in other objective and subjective sleep measurement indicators. In addition, HS-10506 exhibited good safety at all doses. No adverse effects on alertness, cognitive function, depressive or anxiety symptoms were observed after HS-10506 treatment. No rebound insomnia occurred after discontinuation.
 

Kanghong Pharmaceutical has also made new progress in the field of anti-insomnia drugs. On February 25 this year, the company announced that its self-developed KHN707 tablets had been approved for clinical trials for the treatment of insomnia. The announcement stated that KHN707 tablets are a selective orexin 2 (OX2R) receptor antagonist independently developed by Kanghong Pharmaceutical, classified as an innovative chemical drug of Category 1, with a tablet formulation. Results from completed preliminary studies indicate that KHN707 tablets have good safety and demonstrate positive therapeutic effects in insomnia models, with promising prospects for clinical application.
 

In September 2025, Yangtze River Pharmaceutical announced the release of the Phase III pivotal clinical research results for its self-developed Class 1 anti-insomnia innovative drug, Fazamorexant. This study is a multi-center, randomized, double-blind, placebo-controlled Phase III clinical trial, with a total of 1,034 adult patients with insomnia taking the trial medication. The results showed that Fazamorexant, as a dual orexin receptor antagonist, demonstrated rapid efficacy and good safety in adult patients with insomnia. A relevant representative from the Yangtze River Pharmaceutical Group stated that the company has formally submitted a New Drug Application (NDA) for Fazamorexant to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA).
 

Insomnia can trigger anxiety and irritability, increasing the risk of chronic diseases such as cardiovascular disease and diabetes. Long-term insomnia leads to symptoms like lack of concentration and memory decline, which in turn affects life quality and work efficiency. Orexin, a key neuropeptide secreted by the hypothalamus, plays a central role in maintaining wakefulness and regulating the sleep-wake cycle. From the recent progress of companies, pharmaceutical enterprises are continuously conducting research focusing on orexin.
 

It is commendable that in August 2025, Eisai's innovative drug Lemborexant (brand name: Dayvigo) was officially announced to be launched in China. This product is the first dual orexin receptor antagonist approved in China, used to treat adult insomnia patients characterized by difficulty falling asleep and/or maintaining sleep. Unlike traditional drugs, Dayvigo promotes the normalization of the sleep cycle structure by targeting and modulating arousal pathways, inhibiting excessive arousal signals. Reportedly, Dayvigo competitively binds to orexin receptors, blocking the abnormal binding of orexin to its receptors, suppressing excessive arousal signals, regulating the body's natural sleep mechanism, and reshaping the natural rhythm of sleep. As a novel non-sedative sleep aid with a unique mechanism developed in Japan and introduced to China, its efficacy and safety provide a new option for building healthy sleep patterns.
 

Looking ahead, with more innovative R&D from pharmaceutical companies in China, the treatment of insomnia in China is expected to undergo a qualitative change.
 

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