中证报中证网讯（记者 万宇）远大医药12月8日晚公告称，公司用于治疗抑郁症的中药创新药 GPN01360在国内开展的II期临床研究成功达到临床终点。这次临床研究的成功是公司在五官科板块中 成药方向的重大里程碑进展。 公告显示，抑郁症也称抑郁障碍，是一种常见的精神障碍，复发率高达75%-90%，是一种终生性疾病， 是全球精神障碍所致疾病负担的首要原因，也是全球重大的公共卫生问题。根据世界卫生组织 （WHO）最新统计数据，全球大约有3.32亿人患有抑郁症，总患病率4.0%，其中，成人患病率达 5.7%。 目前抑郁症临床治愈率低于30%，临床治疗仍存在一些瓶颈。因此，抑郁症的治疗仍存在较大未满足的 临床需求，公司的GPN01360有望为临床提供一种全新的治疗选择。 远大医药为中国主要的五官科药物研发、生产及销售综合企业之一，在售产品管线数量位居行业前列， 治疗领域覆盖包括眼科、耳鼻喉科、口腔科等多科室疾病，覆盖了化学制剂、中药制剂及健康产品，包 含处方药、OTC、器械、消费品等几大类别，建立了专业化营销团队，形成了覆盖全国的营销网络。 中成药是公司五官科板块的重要布局方向之一，公司立足中医药在慢病治疗领域的核心优势 ...

这一重要成果，标志着远大医药已在中医药现代化领域迈出重要一步，也是公司在中成药方向的重大里程碑进展。未来GPN01360若成功上市，不仅将丰富 公司的产品管线，还可推动业务格局的进一步升级，助力公司将中成药领域的优势拓展至心脑血管慢病及神经内科领域，覆盖更广泛的患者群体，从而为公 司打造新的业绩增长引擎。 经典方剂创新升级，剑指近百亿元抑郁症治疗市场 抑郁症是一种常见且复发率高达75%-90%的精神类疾病，常导致患者情绪低落、兴趣减弱，严重时可导致自杀，极大影响患者的工作和社会生活，也被称为 人类精神健康的"隐形杀手"。 因患者规模庞大且社会影响高，抑郁症已成为全球第四大疾病，也是全球范围内全因伤残引起的健康寿命损失年(years lived with disability，YLDs)的第二大 因素。该病症已困扰全球约3.32亿人，每年可导致近1万亿美元的经济损失。在我国，抑郁症同样高发。中国精神卫生调查显示，我国成年人群抑郁症患病 率为6.8%，高于全球平均水平，目前已有约9500万患者。 近年来，伴随着大众对抑郁症认知的提升，患者的就医需求也正不断上涨，其医药市场也正日益扩容。灼识咨询数据显示，2024年 ...

Investment Rating - The report does not explicitly state an investment rating for the antidepressant drug industry Core Insights - Depression disorders are the most common mental disorders, characterized by persistent low mood, loss of pleasure, and decreased energy. The etiology remains unclear, with various hypotheses including the monoamine hypothesis and glutamatergic system abnormalities [5][23] - There are unmet clinical needs in depression treatment, including limited efficacy of current first-line antidepressants, slow onset of action, and the need for precision treatment for different subtypes and special populations [5][27] - The current market for antidepressants in China is substantial, with over 8 billion yuan in hospital sales, where SSRIs and SNRIs account for approximately 60% of the market share [5][6] - New drug development is focusing on deepening monoamine research, exploring amino acid classes, and other mechanisms, with a gradual entry into a harvest period for innovative drugs [5][6] Summary by Sections Unmet Clinical Needs - Current first-line antidepressants like SSRIs have limited efficacy, with about one-third of patients not achieving remission after multiple treatment steps [27] - The onset of current antidepressants is slow, typically requiring 1-4 weeks for initial improvement and 4-8 weeks to reach treatment goals, posing risks for patients during acute phases [27][28] - There is a need for precision treatment for different subtypes of depression and special populations such as children and the elderly [27] Market Overview - The antidepressant market in China saw over 8 billion yuan in sales, with SSRIs leading at 3.58 billion yuan (43.44% market share) and SNRIs at 1.42 billion yuan (17.18% market share) [5][6] - The top-selling antidepressants include escitalopram oxalate, agomelatine, and sertraline [5] Drug Development Trends - The report highlights ongoing research into monoamine neurotransmitter drugs, with 128 clinical-stage products targeting various mechanisms [5][6] - Innovative drugs are gradually entering the market, with one local innovative drug already launched and over twenty in clinical trials [5][6]

Core Insights - Depression is a significant challenge in clinical psychiatry, as highlighted by the Beijing Brain Science and Brain-like Research Institute's recent findings [1] - The study published in Nature identifies adenosine signaling as a key pathway for the rapid antidepressant effects of ketamine and electroconvulsive therapy (ECT) [1] - The research proposes an "intermittent hypoxia intervention" (aIH) to safely and controllably induce adenosine release in the brain, leading to significant antidepressant effects [1] Summary by Categories Research Findings - The study confirms that adenosine signaling is a common mechanism underlying the rapid antidepressant actions of both ketamine and ECT [1] - This discovery enhances the understanding of rapid antidepressant mechanisms and provides a solid theoretical basis for developing new generation antidepressant strategies with fewer side effects [1] Implications for Treatment - The findings suggest potential for developing small molecule drugs and non-drug interventions targeting adenosine signaling [1] - The research opens avenues for safer and more effective treatment options for depression, addressing a critical need in mental health care [1]

Core Viewpoint - The article discusses the growing market for antidepressant medications in China, driven by an increasing number of patients suffering from depression and the rising acceptance of mental health treatment [5][14][28]. Group 1: Market Dynamics - The total number of individuals with depression in China has reached 95 million, with approximately 38 million registered patients as of 2023, leading to a booming pharmaceutical market [6][7]. - Sales of antidepressant medications in public medical institutions reached a record high of over 9.1 billion yuan in the previous year, marking a 6% year-on-year growth [6]. - The demand for antidepressants has led to significant sales increases for companies like Hansoh Pharmaceutical, which ranks among the top three in the antidepressant market, and Green Leaf Pharmaceutical, whose new drug saw a 99.9% sales surge [7][8]. Group 2: Changing Perceptions and Treatment - There is a noticeable shift in societal attitudes towards mental health, with more individuals, especially the younger generation, actively seeking treatment for depression [14][11]. - The stigma surrounding mental health issues is gradually diminishing, allowing for greater awareness and acceptance of conditions like depression [14][11]. - The article highlights the importance of early detection and intervention in managing depression, although many patients still face barriers to seeking help [11][14]. Group 3: Competitive Landscape - The number of companies producing generic antidepressants has increased significantly, with over 40 generic antidepressants approved for sale this year alone [15][16]. - The competitive landscape is intensifying, with domestic companies aggressively entering the market, leading to price reductions for antidepressant medications [25][28]. - The introduction of centralized procurement has further driven down prices, making medications more accessible to patients [26][28]. Group 4: Challenges in Treatment - Despite the growing market, many patients still struggle with the high costs of original branded medications, which can consume a significant portion of their income [21][22]. - The article notes that the development of new antidepressants is slow due to high research and development barriers, leading to a relatively stable market for existing medications [22][24]. - The perception of antidepressants as "addictive" is discussed, with experts clarifying that withdrawal symptoms are often misinterpreted as addiction [33][34]. Group 5: Future Outlook - The article suggests that as more patients seek treatment and the market continues to evolve, the demand for antidepressants will likely remain strong, despite current market fluctuations [29][30]. - The ongoing changes in pricing and market dynamics may lead to a more sustainable and accessible treatment landscape for patients suffering from depression [28][29].

Core Viewpoint - The article discusses a new strategy for deep brain stimulation (DBS) targeting the anterior cingulate cortex (ACC) that shows promise in treating major depressive disorder (MDD) through a short-duration stimulation that produces long-lasting effects [4][8]. Group 1: Research Findings - The study developed an inhibitory DBS (i-DBS) strategy that requires only about 2 hours of stimulation to rapidly alleviate depressive-like symptoms in mouse models, maintaining effects for several days [4][6]. - The research combined DBS with optogenetics to monitor neuronal activity in the ACC, a critical brain region for depression [4][5]. - Systematic optimization of DBS parameters, including waveform, pulse width, and frequency, allowed the team to reliably inhibit or activate ACC neuronal activity [4][6]. Group 2: Mechanisms and Effects - Optimized DBS parameters can bidirectionally control ACC pyramidal neuron activity [6]. - Inhibiting the ACC produces rapid and sustained antidepressant-like effects, while activating the ACC leads to anhedonia-like behavior [6][8]. - Inhibition of the ACC suppresses activity across the brain's emotional regulation network [6]. Group 3: Implications for Treatment - The research establishes a principled framework for optimizing DBS parameters and suggests that targeting ACC inhibition may be a potential strategy for treating major depressive disorder [8].

Core Viewpoint - The research highlights the development of an efficient method to differentiate human pluripotent stem cells (hPSCs) into A10 subtype midbrain dopaminergic neurons (A10 mDA), which can integrate into mouse brain circuits and improve depression-like behaviors [3][6][9]. Group 1: Research Background - A10 mDA neurons play a crucial role in reward-related and goal-directed behaviors and are considered target cells for treating various mental disorders, including depression [3][5]. - Previous studies have successfully induced differentiation of midbrain dopaminergic neurons (mDA) from hPSCs, but efficient differentiation of A10 mDA has been challenging [5][6]. Group 2: Research Methodology - The study reports a method for efficiently differentiating A10 mDA from hPSCs using Notch inhibitors, glial cell-derived neurotrophic factor (GDNF), and ascorbic acid (AA) [6][7]. - The differentiated A10 mDA neurons exhibited characteristics specific to the A10 subtype, including gene expression profiles and electrophysiological properties [6][7]. Group 3: Research Findings - Transplantation of A10 mDA into the nucleus accumbens (NAc) resulted in specific projections to endogenous target brain regions, inducing significant anti-anxiety phenotypes in normal mice and effectively alleviating depression-like phenotypes in depression model mice [6][7]. - The study emphasizes the potential of hPSC-derived neuron subtypes in treating neuropsychiatric disorders by functionally repairing damaged circuits [9].

Summary of Key Points from Conference Call on Antidepressant Drugs Industry Overview - The conference discusses the antidepressant drug industry, focusing on the clinical challenges and drug development landscape for treating depression, a prevalent mental health disorder with unclear pathophysiology [1][2]. Core Insights and Arguments - **Clinical Pain Points**: Current mainstream antidepressants face significant clinical challenges, including: - **Ineffective Treatment**: Approximately 60% efficacy rate, meaning not all patients can effectively control symptoms [7]. - **Slow Onset of Action**: Most existing antidepressants take 1-2 weeks or longer to show effects, which is particularly distressing for severe patients [7]. - **Safety Concerns**: Long-term use can lead to side effects such as sexual dysfunction, weight gain, and negative impacts on sleep quality [7][4]. - **Drug Development Challenges**: The slow iteration of psychiatric drugs is attributed to: - Lack of significant breakthroughs in understanding the mechanisms of mental illnesses [5]. - High failure rates in new drug development, leading to reduced investment from pharmaceutical companies in the CNS (central nervous system) sector [5] [6]. - **Current Drug Landscape**: - New drugs like **Trazodone** and **S-ketamine nasal spray** have been introduced, with Trazodone being a novel antidepressant developed by Shandong Green Leaf, which acts on serotonin, norepinephrine, and dopamine [2]. - S-ketamine has been successful in overseas markets due to its rapid onset but faces strict regulations in China due to its classification as a controlled substance [10][14]. - **Market Potential**: - Treatment for moderate to severe depression has greater market potential, as approximately 40%-50% of patients fall into this category, while treatment-resistant depression accounts for about 20%-30% of cases [15]. Important but Overlooked Content - **Clinical Trial Design**: Antidepressant clinical trials primarily rely on subjective scale results for efficacy evaluation, which can lead to high placebo effects, especially in mild to moderate depression cases [12][13]. - **Patient Considerations**: Clinicians must consider various factors when selecting treatment, including the severity of the patient's condition, suicidal ideation, age, and potential drug interactions [8][9]. - **Future Opportunities**: The potential for a new oral antidepressant with similar efficacy to S-ketamine but with fewer side effects could present significant market opportunities, contingent on successful development [11]. Conclusion - The antidepressant drug industry is at a critical juncture, facing significant clinical challenges and development hurdles. However, there is a notable market opportunity for innovative treatments targeting moderate to severe depression, particularly if they can address the current limitations of existing therapies.

Group 1 - The technology opens new avenues for treating refractory mental illnesses, including treatment-resistant depression, obsessive-compulsive disorder, and tic disorders [1][3] - A case study from Ruijin Hospital highlights a 32-year-old patient with a 16-year history of depression who benefited from a novel therapy combining deep brain stimulation (DBS) and brain-computer interface (BCI) technology [1] - The innovative treatment involves the implantation of two electrodes with 16 stimulation contacts into the brain's emotional circuit, allowing for precise modulation and breaking the cycle of depression [1][3] Group 2 - The DBS combined with BCI technology is a minimally invasive intervention that avoids the memory loss associated with electroconvulsive therapy and the side effects of long-term medication [3] - This new therapy has already been clinically applied to over 30 cases, providing a new option for treatment-resistant depression patients [3] - Depression is increasingly recognized as a significant mental health issue, particularly among younger populations, with a reported prevalence of 15% to 20% among adolescents in China [3]

Company Overview - Brainsway Ltd. shares (BWAY) experienced a 5.3% increase, closing at $11.49, with notable trading volume compared to typical sessions [1] - The company is expected to report quarterly earnings of $0.04 per share, unchanged from the previous year, with revenues projected at $12.39 million, reflecting a 23.8% increase year-over-year [3] Clinical Trial Results - The recent rise in BWAY shares is linked to positive market sentiment following successful clinical trial results for BrainsWay's accelerated Deep TMS therapy for Major Depressive Disorder (MDD) [2] - The multicenter, randomized study showed statistically significant improvements in depression symptoms, a favorable safety profile, and rapid onset of effect, positioning BrainsWay's technology as a leading non-invasive treatment option for MDD [2] Earnings Estimates and Market Sentiment - The consensus EPS estimate for Brainsway has been revised 10% higher in the last 30 days, indicating a positive trend that typically correlates with price appreciation [4] - The stock currently holds a Zacks Rank of 3 (Hold), suggesting a neutral outlook in the market [5] Industry Comparison - Brainsway operates within the Zacks Medical - Products industry, where Boston Scientific (BSX) also competes, having closed 1.1% higher at $102.36, but with a -3.1% return over the past month [5] - Boston Scientific's consensus EPS estimate has increased by 0.1% to $0.72, representing a 16.1% change compared to the previous year [6]