Epidemiological data shows that the prevalence of epilepsy in China ranges 4‰~7‰, with the prevalence of active epilepsy at 4.6‰, and an annual incidence rate of 30 per 100,000 people¹. Based on these estimates, there are nearly 10 million people with epilepsy in China, including 6.4 million patients with active epilepsy, and approximately 300,000 new cases emerging each year¹.

Currently, the primary goal of epilepsy treatment is to control seizures, with medication serving as main approach. If drugs prove ineffective, physicians may adjust dosages, switch medications, add supplementary treatment, or consider alternative therapies, such as the ketogenic diet. Although patients with epilepsy now have a variety of treatment options available, approximately 30% of patients remain refractory to existing therapeutic approaches².

1. 中国抗癫痫协会. 临床诊疗指南. 癫痫病分册[J]. 人民卫生出版社, 2023.
2. Privitera M, Richy FF, Schabert VF. Indirect treatment comparison of cenobamate to other ASMs for the treatment of uncontrolled focalseizures [J]. Epilepsy Behav. 2022, 126: 108429.

OSA (Obstructive Sleep Apnea) and narcolepsy are two primary causes leading to Excessive Daytime Sleepiness (EDS). The prevalence of narcolepsy is relatively low, at approximately 0.034%, classified as a rare disease in China and other countries.

The overall prevalence of Obstructive Sleep Apnea in adults is 3.93%², with China having an estimated 176 million OSA patients, making it the country with the highest number of OSA patients in the world.

Excessive Daytime Sleepiness (EDS) profoundly impacts daily life and health, leading to reduced quality of life and work performance, increased risks for cardiovascular disease, diabetes, mental health issues, obesity, and heightened risks for accidents in workplaces and public transportation.

Current treatment for Excessive Daytime Sleepiness (EDS) still have limitations.

Common therapeutic approaches for narcolepsy involve pharmacotherapy; however, in China, the selection of drugs for treating narcolepsy is limited and accessibility is poor. There remains an urgent need for innovative products for EDS treatment to meet the demands of a large patient population in China.

For patients with Obstructive Sleep Apnea (OSA) combined with EDS, Continuous Positive Airway Pressure (CPAP) is recommended as the first-line treatment by guidelines⁴, yet patients often struggle with intolerance and poor adherence to CPAP therapy. Furthermore, a substantial number of OSA patients continue to suffer from residual EDS even after CPAP treatment.

1. Wing, Yun-Kwok et al. “The prevalence of narcolepsy among Chinese in Hong Kong.” Annals of neurology vol. 51,5 (2002): 578-84. doi: 10.1002/ana. 10162.
2. 潘悦达, 王东博, 韩德民. 我国成人阻塞性睡眠呼吸暂停低通气综合征患病率的 Meta 分析. 医学信息32.07(2019): 73-77+81.
3. Benjafield, Adam V et al. “Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis.” The Lancet. Respiratory medicine vol. 7,8 (2019): 687-698. doi: 10.1016/S2213-2600(19)30198-5.
4. 成人阻塞性睡眠呼吸暂停多学科诊疗指南[J]. 中华医学杂志, 2018, 98(24).

According to research statistics, approximately 10-30% of the global population experiences symptoms of insomnia, with a slightly higher prevalence in women than in men².

Insomnia severely impairs patients' physical and mental health, affecting their quality of life, and can even lead to accidents such as traffic incidents, posing risks to both personal and public safety, thereby imposing a serious burden on individuals and society³.

Current treatment options for insomnia still have limitations. For chronic insomnia, Cognitive Behavioral Therapy for Insomnia (CBTI) is the preferred treatment method. When patients actively participate, the effectiveness can reach around 80%, demonstrating superior efficacy compared to medication. However, since CBTI requires active patient engagement, its utilization is limited, and more patients opt for sleep medication. While there are numerous insomnia drugs currently available on the market, most come with issues such as dependency and drug resistance, leaving a significant amount of unmet needs.

1. CAO X L, WANG S B, ZHONG B L, et al. The prevalence of insomnia in the general population in China: A meta-analysis[J].
2. Roth, T. Insomnia: Definition, Prevalence, Etiology, and Consequences J CLIN SLEEP MED. 2007; 3 (5 suppl).
3. 中国失眠症诊断和治疗指南[J]. 中华医学杂志, 2017, 97(24).

Parkinson's disease imposes a tremendous societal and medical burden: the prevalence in the Chinese population aged 65 and over is 1.7%, similar to that in Western countries. By 2030, the number of Parkinson's disease patients in China is projected to rise to 5 million, accounting for almost half of the global patient population².

Parkinson's disease has numerous negative impacts on patients, reducing quality of life, decreasing the ability to perform daily activities, lowering working hours and productivity, increasing the risk of mood disorders, raising the frequency of doctor visits and hospitalizations, and escalating economic burdens. Additionally, it increases the burden on caregivers and strains the healthcare system^3-9.

Current treatment for Parkinson's disease, whether pharmacological or surgical, only alleviate symptoms and cannot halt disease progression or achieve a cure². Levodopa is the standard therapy for Parkinson's disease, but delayed gastric emptying and consumption of high-protein foods can result in unstable levodopa absorption^2,10-11. Moreover, as the disease advances and with prolonged use of levodopa, patients experience fluctuations between 'on' (adequate symptom control) and 'off' periods (inadequate symptom control, with the emergence or worsening of motor and/or non-motor symptoms leading to functional impairment). Despite doctors recommending optimization of medication doses and oral timing alongside adjunctive therapies, the phenomenon of 'off' periods remains pervasive^2,11-12.

1. 贾建平等, 神经病学(第8版).
2. 中华医学会神经病学分会帕金森病及运动障碍学组等. 中华神经科杂志, 2020, 53(12): 973-986.
3. Damier P, et al. Parkinsons Dis. 2022; 2022: 1800567.
4. Kerr C, et al. Qual Life Res. 2016 Jun; 25(6): 1505-15.
5. Abeynayake I, et al. Am J Manag Care. 2020; 26(12 Suppl): S265-S269.
6. 4. van der Velden RMJ, et al. Mov Disord. 2018; 33(10): 1521-1527.
7. Thach A, et al. J Med Econ. 2021; 24(1): 540-549.
8. Thach A, et al. 2020 ISPOR. PND86.
9. Thach A, et al. J Med Econ. 2021; 24(1): 540-549.
10. Masood N, et al. Neuropsychiatr Dis Treat. 2023; 19: 247-266.
11. Isaacson SH, et al. Mov Disord Clin Pract. 2023 Mar 11; 10(4): 652-657.
12. Chou KL, et al. Parkinsonism Relat Disord. 2018; 51: 9-16.

According to the 2016 Global Burden of Diseases (GBD) study, migraine ranks as the second most disabling neurological disorder. Approximately one-seventh of migraine sufferers in China experience aura symptoms. An epidemiological survey conducted in 2009 revealed that the annual prevalence of migraine in the Chinese population aged 18 to 65 years was 9.3%¹.

There remain significant deficiencies in the diagnosis and treatment of migraine in China, with a consultation rate of only 52.9% among patients and a correct diagnosis rate by physicians of just 13.8%¹.

Migraine treatment is approached from two angles: one focusing on pain relief during acute attacks, and the other on preventive therapy aimed at chronic recurring headaches. Current pharmacological interventions are marred by inadequate responses, the risk of headache chronification due to long-term analgesic use, and the potential for medication-overuse headache.

1. 中国医师协会神经内科医师分会, 中国研究型医院学会头痛与感觉障碍专业委员会, 董钊, 等. 中国偏头痛诊治指南(2022版)[J]. 中国疼痛医学杂志, 2022, 28(12): 881-898.
2. Yao et al. The Journal of Headache and Pain (2019) 20: 102.

The International Association for the Study of Pain's Neuropathic Pain Special Interest Group (NeuPSIG) estimates the prevalence of neuropathic pain to range from 3.3% to 8.2%. A study from Europe indicates that the prevalence of neuropathic pain in the general population may be as high as 8.0%¹.

Diabetic peripheral neuropathic pain is the most common chronic complication of diabetes, affecting 16% of diabetic patients. It is estimated that approximately 22 million people in China suffer from diabetic peripheral neuropathic pain. Postherpetic neuralgia is also a common occurrence, with an annual incidence of 3.9-42.0 per 100,000. Trigeminal neuralgia, a common cranial nerve disease, has a prevalence of 182 per 100,000, primarily affecting adults and the elderly, peaking in ages 48-59².

Neuropathic pain often coexists with sleep disorders, anxiety, and depression, severely compromising patients' quality of life and imposing substantial economic burdens on society.

Taking patients with postherpetic neuralgia in China as an example, the average annual out-of-pocket expense per patient is 16,873 RMB, and the indirect loss due to reduced productivity is 28,025 RMB per year².

The treatment approach for neuropathic pain is multidimensional, individualized, and stepwise, requiring a multidisciplinary collaborative approach involving pain specialists, neurologists, rehabilitation physicians, psychologists, and social workers. Based on assessment outcomes and team discussions, personalized pain management plans are formulated, incorporating pharmacological treatment, physical therapy, minimally invasive interventions, psychological therapy, cognitive behavioral therapy, rehabilitation exercises, and surgical options. However, due to the complex mechanisms underlying neuropathic pain, clinical treatment for chronic neuropathic pain patients is often inadequate or inappropriate³. Furthermore, the limited availability of drugs for neuropathic pain treatment, coupled with adverse reactions that can exacerbate symptoms, poses significant challenges.

1. 神经病理性疼痛诊疗专家组. 神经病理性疼痛诊疗专家共识[J]. 中国疼痛医学杂志, 2013, 19(12): 705-710. DOI: 10.3969/ j.issn. 1006-9852. 2013. 12. 001.
2. 周围神经病理性疼痛诊疗中国专家共识[J]. 中国疼痛医学杂志, 2020, 26(5): 321-328. DOI: 10.3969/ j.issn. 1006-9852. 2020. 05. 001.
3. 国家疼痛专业质控中心神经病理性疼痛专家组, 段宝霖, 樊碧发, 冯开儒, 冯智英, 傅志俭, 何睿林, 黄佑庆, 李君, 刘广召, 刘起颖, 罗芳, 马锐, 申文, 孙涛, 陶高见, 陶蔚, 魏建梅, 吴大胜, 夏令杰, 夏明, 肖礼祖, 许丽媛, 杨东, 姚鹏, 张达颖, 郑拥军, 朱谦. 神经病理性疼痛评估与管理中国指南(2024版)[J]. 中国疼痛医学杂志, 2024, 30(1): 5-14. DOI: 10.3969/ j.issn. 1006-9852. 2024. 01. 003.

Globally, approximately 50 million people are living with Alzheimer's disease or related dementias. It is projected that by 2050, this number will balloon to around 150 million. The condition poses a massive burden on patients, families, and socioeconomic systems. The total annual cost of Alzheimer's disease and other dementias worldwide is estimated to exceed $1 trillion³.

As the population ages, Alzheimer's disease emerges as a global health issue with profound impacts on individuals, families, and societies at large. However, therapeutic options for Alzheimer's disease remain severely limited; existing medications can only provide temporary symptomatic relief without halting or reversing the disease progression. This is largely because Alzheimer's disease is a complex, multi-factorial condition, with its etiology stemming from a combination of genetic predispositions and environmental influences. In light of the immense disease burden, etiological research targeting the causes and modifiable risk factors of Alzheimer's disease has become a focal point in neuroscience.

1. Lane C A, Hardy J, Schott J M. Alzheimer's disease[J]. European Journal of Neurology, 2018, 25(1): 59-70.
2. Lancet Public Health 2020; 5: e661–71.
3. International A S D. World Alzheimer report 2019: Attitudes to dementia[R]. London: Alzheimer’s Disease International, 2019.

Approximately 23 million people in China are estimated to have ADHD, contributing to a substantial disease burden. Globally, the childhood incidence is about 7.2%, with 60% to 80% of cases persisting into adolescence, and 50.9% continuing into adulthood as adult ADHD. In China, the prevalence of ADHD in children is 6.26%, affecting roughly 23 million individuals, yet the consultation rate is only around 10%¹.

ADHD leads to poor academic performance, diminished quality of life, increased risk of accidents, premature death and suicide, criminal behavior, emotional and social impairments, and substance use disorders, imposing a significant disease burden³. Current treatment for ADHD include non-pharmacological and pharmacological approaches¹. However, the potential for drug misuse and dependence, along with long-term risks such as growth suppression, suicidality, and cardiovascular events, limit the application of medications^1,4-6. Medication non-adherence in children and adolescents with ADHD over a 12-month period is alarmingly high, ranging from 36% to 90.2%⁷. Beyond pharmacotherapy, emerging cutting-edge treatment like neuromodulation are being explored as alternative therapies for ADHD^8-9.

1. 中华医学会儿科学分会发育行为学组. 中华儿科杂志, 2020, 58(3): 188-193.
2. 郑毅等, 中国注意缺陷多动障碍防治指南(第二版).
3. Faraone SV, et al. Neurosci Biobehav Rev. 2021 Sep; 128: 789-818.
4. LABEL-ADHANSIA XR (methylphenidate hydrochloride) extended-release capsules, for oral use.
5. Posner J, et al. Lancet. 2020 Feb 8; 395(10222): 450-462.
6. 盐酸托莫西汀胶囊说明书.
7. Gajria K, et al. Neuropsychiatr Dis Treat. 2014 Aug 22; 10: 1543-69.
8. 徐瑾姣, 等. 中国现代医生. 2023, 61(23): 124-27.
9. Rubia K, et al. Cells. 2021 Aug 21; 10(8): 2156.

Depression has a high prevalence rate and imposes a heavy disease burden. In China, the lifetime prevalence of depression is as high as 3.4%², and the 12-month prevalence is 2.1%². According to the findings of the Global Burden of Disease study, the years lived with disability (YLDs) attributable to depressive disorders rank second among all diseases³.

At present, the common treatment modalities for depression encompass pharmacological therapy, psychological therapy, and brain stimulation therapies. Pharmacological therapy continues to be the most commonly employed clinical intervention, yet there exists a substantial unaddressed medical need. Research indicates that patients often require several weeks before antidepressant drugs start to exert their effects; between 20-30% of depression patients exhibit inadequate response or poor improvement despite adequate dosing and duration of treatment with two or more distinct antidepressants; the risk of suicidal acts or completed suicides in individuals with depression is markedly greater compared to the general population, with an estimated lifetime risk of suicide standing at 6%; depression is characterized by a high recurrence rate, with recurrences occurring at rates up to 50-85%, wherein approximately half of the patients experience a recurrence within two years following the onset of their illness.

1. 美国精神医学学会. 精神障碍诊断与统计手册. 案头参考书. 第5版.
2. Huang Y, Wang Y, Wang H, Liu Z, Yu X, Yan J, et al. Prevalence of mental disorders in China: a cross-sectional epidemiological study. Lancet Psychiatry. 2019; 6(3): 211-24.
3. Collaborators GBDMD. Global, regional, and national burden of 12 mental disorders in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Psychiatry. 2022; 9(2): 137-50.

According to estimates by the World Health Organization (WHO), the global lifetime prevalence of schizophrenia is 3.8‰~8.4‰. A national epidemiological study found that the lifetime prevalence of schizophrenia in China is 0.6%². The high hospitalization rate and high disability rate associated with schizophrenia are direct causes leading to poverty among patients and can contribute to impoverishment of their families. Furthermore, patients with schizophrenia who exhibit behaviors that endanger lives and property also pose issues for public safety¹.

Since the introduction of antipsychotic medications into clinical use in the 1950s, patients with schizophrenia have been provided with opportunities for treatment and rehabilitation. However, up to the present day, there has been no satisfactory improvement in long-term prognoses, and substantial unmet needs remain:

● Poor medication adherence is a significant issue; about 60% of patients who experience their first episode show poor adherence to medication, and 74% of patients with schizophrenia discontinue their medication within one and a half years of starting treatment.
● Patients may experience adverse reactions to the medication, such as weight gain, increases in blood glucose and lipid levels.
● More than 50% of patients encounter new problems or symptoms during their recovery process due to the stigma associated with mental illness ("mental health stigma").
● The effectiveness of medication in treating cognitive impairments is suboptimal, which negatively impacts the restoration of social function¹.

1. 赵靖平; 施慎逊. 中国精神分裂症防治指南(第二版).
2. Huang Y, Wang Y, Wang H, Liu Z, Yu X, Yan J, et al. Prevalence of mental disorders in China: a cross-sectional epidemiological study. Lancet Psychiatry. 2019; 6(3): 211-24.