New analysis of a Phase 3 study of daridorexant shows that 50 mg improved both sleep and daytime functioning compared to placebo in women during menopausal transition ageBrigham and Women’s Hospital to study the effectiveness and safety of daridorexant for menopause-related insomnia symptoms Allschwil, Switzerland – January 5, 2026Idorsia Ltd (SIX: IDIA) announces the publication of “Efficacy and safety of daridorexant for the treatment of insomnia disorder in women during menopausal transition age: Insight ...

Investment Rating - The report maintains a positive outlook on the insomnia treatment market, highlighting the potential for new drug sales performance in this sector [20][32]. Core Insights - The insomnia treatment market in China is characterized by a significant unmet need, with over 200 million individuals estimated to suffer from insomnia symptoms, representing a large consumer market potential [16][24]. - The report emphasizes the shift towards innovative insomnia medications, particularly focusing on new types of benzodiazepine receptor agonists (BZRAs) and dual orexin receptor antagonists (DORAs) as key areas for development [25][38]. - The introduction of new drugs like JY-202 (地达西尼) and DORA medications is expected to reshape the market dynamics, with a forecasted rapid increase in market share and sales [34][39]. Market Overview - The insomnia drug market in China has seen stagnant growth due to a lack of new effective treatments, with the market size in 2023 estimated at 31.62 billion yuan [24]. - The report outlines the historical sales performance of major insomnia medications, indicating a long gap since the last new product launch in 2007, which has contributed to the current market stagnation [24][25]. - The report projects a significant increase in the market size and sales for innovative insomnia drugs, particularly with the anticipated approval and market entry of new products [34][39]. Drug Development Trends - The report identifies two main directions for insomnia drug innovation: improvements on existing BZRAs and the development of DORAs, which are expected to have lower addiction risks and better patient compliance [25][38]. - The new drug JY-202 is highlighted for its selective action on the GABAA receptor, which may reduce side effects associated with traditional insomnia medications [34]. - The report also notes the successful clinical trial results for DORAs, which have shown significant improvements in sleep quality without the risk of addiction, making them suitable for broader consumer use [38][39]. Key Players and Recommendations - The report suggests focusing on companies like 京新药业 (JY-202) and 先声药业 (DORA medications) as they are positioned to capitalize on the emerging market opportunities in insomnia treatment [34][39]. - It recommends monitoring the sales performance of these new drugs as they enter the market, particularly in the context of changing consumer behavior and increasing awareness of sleep health [20][32].

证券研究报告 | 医药生物 | 2025年12月20日 www.hczq.com 华创医药投资观点&研究专题周周谈 ·第155期 失眠治疗蓝海大市场,看好上市新药销售表现 本周专题联系人:朱珂琛 | 华创医药团队： | | | --- | --- | | 首席分析师郑辰 | 执业编号: S0360520110002邮箱: zhengchen@hcyjs.com | | 联席首席分析师刘浩 | 执业编号:S0360520120002邮箱:liuhao@hcyjs.com | | 医疗器械组组长李婵娟 | 执业编号: S0360520110004邮箱: lichanjuan@hcyjs.com | | 中药和流通组组长高初营 | 执业编号: S0360524070002邮箱: gaochulei@hcyjs.com | | 分析师王宏雨 | 执业编号: S0360523080006邮箱:wanghongyu@hcyjs.com | | 分析师朱珂琛 | 执业编号: S0360524070007邮箱: zhukechen@hcyjs.com | | 分析师陈俊威 | 执业编号：S0360525060002邮箱:ch ...

Core Viewpoint - Melatonin is often perceived as a natural solution for insomnia, but its use carries significant health risks and is not a universal remedy for sleep disorders [2][6]. Group 1: Melatonin and Its Effects - Melatonin is a hormone secreted by the pineal gland, primarily increasing in production during the evening to promote sleep [4]. - Over-the-counter melatonin supplements are exogenous and act as "rhythm regulators," potentially effective for jet lag but not for insomnia caused by anxiety or other physical conditions [6]. - Long-term use of melatonin can suppress the body's natural production of the hormone, leading to rebound insomnia or dependency upon cessation [8]. Group 2: Risks of Self-Medication - Self-medicating with melatonin or combining it with other sleep aids, such as sedatives, can mask underlying conditions like depression or anxiety, delaying proper diagnosis and treatment [9]. - Anxiety and depression can exacerbate insomnia, and without addressing these root causes, sleep issues may persist, potentially leading to increased reliance on sleep medications [11]. Group 3: Recommendations for Sleep Improvement - For short-term insomnia, mild interventions like certain herbal supplements may be acceptable, but persistent symptoms lasting over two weeks should prompt a visit to a specialist for targeted treatment [12]. - A comprehensive approach to improving sleep includes timely medical consultation, adjustment of sleep habits, regular exercise, balanced diet, and emotional regulation [12][14].

Group 1 - The current influenza activity in China has entered a rapid rising phase, with most provinces reaching moderate epidemic levels and some provinces even reaching high epidemic levels [1][2] - The predominant strain for the 2025-2026 flu season is the H3N2 subtype, differing from the previous season which was dominated by the H1N1 subtype. There is also co-circulation of H1N1 and B type influenza viruses [2] - There has been a significant increase in reported outbreaks of influenza in childcare institutions and schools, with a notably higher positive rate of influenza virus detection in the 5-14 age group compared to other age groups [2] Group 2 - It is crucial to differentiate between common colds and influenza, as influenza typically presents with more severe systemic symptoms such as fever and muscle aches, while common colds are characterized by milder symptoms [3] - Rapid testing methods for influenza are available, allowing for diagnosis within half an hour, and early antiviral treatment is highly effective [3][4] - High-risk groups, including infants, the elderly, pregnant women, and those with chronic conditions, should seek medical attention promptly if diagnosed with influenza to prevent severe complications [4]

Group 1 - Sleep is essential for survival and has several important functions, including promoting growth and development, restoring energy, clearing metabolic waste, and maintaining cognitive function [2][4][5] - Sleep is crucial for immune function, as insufficient sleep can lead to increased susceptibility to illness [5] - Continuous and deep sleep is necessary for cognitive health; fragmented sleep can lead to rapid cognitive decline [8][10] Group 2 - Individuals have different sleep needs based on their unique characteristics; understanding one's own sleep requirements is important for optimal functioning [11][13] - Insomnia is a common issue, with symptoms ranging from occasional sleeplessness to chronic insomnia disorders, which can significantly impact daily functioning [12][23] - Sleep quality can be affected by various factors, including lifestyle habits, age, and underlying health conditions [16][19][22] Group 3 - Sleep duration and quality are linked to overall health; both excessive and insufficient sleep can increase mortality risk and other health issues [19][18] - The importance of maintaining a regular sleep schedule and healthy lifestyle habits, including diet and exercise, is emphasized for better sleep quality [53][54] - Various methods, such as cognitive behavioral therapy for insomnia (CBTI), can be effective in treating sleep disorders [44][45]

Core Insights - Sleep disorders have become a significant health issue affecting nearly half of the adult population in China, with a sleep disturbance rate of 48.5% among individuals aged 18 and above [1][2] - The average sleep duration for this demographic is between 7.06 to 7.18 hours, with women experiencing higher rates of sleep disturbances (51.1%) compared to men (45.9%) [1] - The prevalence of sleep disturbances increases with age, peaking at 73.7% among those aged 65 and above [1] Group 1: Health Implications - Insomnia is linked to various physical and mental health issues, including hypertension, diabetes, coronary heart disease, and cancer [1] - It also contributes to increased anxiety and a higher risk of suicide, as well as a rise in traffic accidents and decreased work efficiency, leading to greater socioeconomic burdens [1][2] Group 2: Treatment and Interventions - Multiple intervention methods for insomnia include lifestyle adjustments, psychological therapy, and pharmacological treatments, with a focus on cognitive behavioral therapy (CBT-I) as a primary approach [3][4] - New drug developments, particularly DORA (Dual Orexin Receptor Antagonists), aim to improve sleep quality without the side effects associated with traditional insomnia medications [5][6] Group 3: Market Potential - The sleep economy in China is projected to reach a market size of 534.93 billion yuan in 2024, with expectations to grow to 658.68 billion yuan by 2027, indicating strong growth potential [4] - The insomnia medication market was valued at 12.28 billion yuan in 2021, with forecasts of reaching 15.12 billion yuan by 2025 and 21.19 billion yuan by 2030 [5] Group 4: Regulatory and Accessibility Aspects - Recently approved DORA medications, such as Lemborexant and Daridorexant, have been included in the preliminary review list for the national medical insurance directory, enhancing their market accessibility [6] - These medications are not classified as controlled substances, which increases patient access and allows for innovative distribution channels, including e-commerce [6][7]

Core Insights - Dalirelix, developed by Xiansheng Pharmaceutical in collaboration with Swiss Idorsia, was approved by the National Medical Products Administration in June 2023 for treating adult insomnia characterized by difficulty in falling asleep and/or maintaining sleep [1][2] - The drug has shown excellent performance in improving sleep onset time, nighttime awakening, self-reported sleep duration, sleep quality, and daytime functioning, with good safety and tolerability [1] - The prevalence of sleep disturbances among individuals aged 18 and above in China is reported at 48.5%, with symptoms including difficulty falling asleep, frequent awakenings, and early morning awakenings [1] Company Initiatives - Xiansheng Pharmaceutical plans to invest 10 million yuan annually, totaling 30 million yuan over three years, to further research the value of Dalirelix for patients [2][4] - The research will include subgroup studies on the efficacy and safety of Dalirelix for patients with insomnia combined with anxiety/depression, cancer, cardiovascular diseases, autoimmune diseases, obstructive sleep apnea, and stroke [2] - The "All Heavy Search Plan" aims to expand research in the field of neurology and insomnia, providing more real-world medication evidence for patients with comorbid neurological and psychiatric conditions [4]

Core Insights - The launch of the new insomnia drug, Lemborexant (brand name: Dazai Ke), on e-commerce platforms in early August exceeded expectations, selling over 8,000 boxes on the first day [1] - Lemborexant is the first dual orexin receptor antagonist approved in China, marking a significant innovation in the insomnia treatment market after a decade without new drugs [1][3] - The drug is not classified as a controlled substance, allowing for easier access and fewer restrictions for patients [3] Company Performance - Lemborexant achieved a projected global sales figure of $370 million in 2024, leading its category [1] - The drug has received positive market feedback in over 20 countries, particularly in Japan, where it holds a 40% market share in the prescription sleep aid market [3] Market Demand - There is a high demand for effective insomnia treatments among patients, particularly those suffering from chronic sleep issues due to work-related stress [3][9] - The company recognizes the need for better management of sleep disorders and aims to improve accessibility and treatment standardization for insomnia patients [3][14] Regulatory and Clinical Considerations - Lemborexant's mechanism of action allows for a more natural sleep induction with fewer side effects, distinguishing it from traditional sedative medications [3][10] - The company emphasizes the importance of proper medication use and gradual transition from older medications to avoid withdrawal symptoms [12][13] Future Directions - The company plans to focus on sleep health as a key business area, with ongoing research for new drugs targeting sleep-related issues [17] - There are efforts to push for Lemborexant's inclusion in health insurance to reduce patient costs and expand market access [18]

Core Insights - The launch of the new insomnia drug, Lemborexant (brand name: Dazai Ke), on e-commerce platforms in early August saw over 8,000 boxes sold on the first day, surprising the company [1] - Lemborexant is the first dual orexin receptor antagonist approved in China, marking a significant innovation in the insomnia treatment market after a decade without new drugs [1][2] - The drug has achieved a global sales forecast of $370 million in 2024, leading its category [1] - The drug's success in China was unexpected, as the company initially focused on the hospital market, but demand from e-commerce channels proved strong [1] Market Potential - There are hundreds of millions of people in China suffering from sleep disorders, indicating a vast potential market for insomnia treatments [2] - Lemborexant is not classified as a controlled substance, allowing easier access for patients compared to traditional sedative medications [2] Patient Experience - A patient named Li Wei, who has struggled with insomnia for years, reported positive experiences with Lemborexant, noting improved sleep quality without significant side effects [9] - However, not all patients have had the same success, with some experiencing difficulties in adjusting to the new medication [9] Treatment Guidelines - The treatment of insomnia requires a tailored approach, considering various underlying conditions and the need for proper medication management [10] - The company emphasizes the importance of rational drug use and gradual transitions from traditional medications to Lemborexant to avoid withdrawal symptoms [10][12] Healthcare System Challenges - There is a lack of specialized clinics for sleep disorders in China, making it difficult for patients to receive appropriate care [14] - The government is promoting the establishment of sleep clinics, with a goal for widespread availability by 2027, but challenges remain in integrating multidisciplinary approaches [14] Future Directions - The company plans to focus on sleep health management, aiming to expand market access for Lemborexant and develop new drugs targeting other sleep-related issues [15] - Collaboration with healthcare providers and institutions is encouraged to enhance clinical experience and public awareness regarding sleep health [15]