Core Viewpoint - The company has received approval from the U.S. Food and Drug Administration (FDA) for its novel chemical drug SYH2056, a selective 5-HT2A receptor agonist, to conduct clinical trials in the U.S. [1] - The product has also been approved by the National Medical Products Administration (NMPA) of China for clinical trials starting in November 2025 [1] Group 1 - SYH2056 is designed to improve the condition of patients with depressive disorders by activating the 5-HT2A receptor, providing rapid onset of action with lasting effects and no hallucinogenic risks [1] - The clinical indication for this product is specifically for the treatment of depression [1] - Preclinical studies indicate that SYH2056 effectively promotes the generation of dendrites and dendritic spines in central nervous neurons, demonstrating neuroplasticity effects [1] Group 2 - In various animal models of depression, SYH2056 has shown excellent antidepressant activity while significantly reducing the potential hallucinogenic risks associated with the target [1] - The product exhibits favorable pharmacokinetic (PK) characteristics and safety, positioning it as a potential best-in-class antidepressant [1] - The company has submitted multiple patent applications for this product both domestically and internationally [1]

Core Viewpoint - The approval of SYH2056, a selective 5-HT2A receptor agonist developed by the company, for clinical trials in China represents a significant advancement in the treatment of depression, addressing unmet clinical needs in the market [1] Company Summary - The product SYH2056 has received approval from the National Medical Products Administration of China for clinical trials, targeting the treatment of depression [1] - SYH2056 is designed to activate the 5-HT2A receptor, which can rapidly improve the condition of patients with depressive disorders with a single dose, offering prolonged efficacy without the risk of hallucinations [1] - Preclinical studies indicate that SYH2056 effectively promotes the generation of dendrites and dendritic spines in central nervous neurons, suggesting a role in neuroplasticity [1] - The company has submitted multiple patent applications for SYH2056 both domestically and internationally [1] Industry Summary - There is a significant clinical demand for new mechanisms in the treatment of depression, as traditional antidepressants have numerous limitations that cannot be overcome [1] - The potential of SYH2056 to become a best-in-class antidepressant is supported by its excellent antidepressant activity in various animal models and favorable pharmacokinetic properties [1] - The product's development aligns with the growing need for innovative treatments in the mental health sector, particularly for depression [1]

Core Viewpoint - The announcement highlights that the pharmaceutical company, Shiyao Group, has received approval from the National Medical Products Administration of China to conduct clinical trials for its novel Class 1 chemical drug, SYH2056, a selective 5-HT2A receptor agonist aimed at treating depression [1] Group 1: Product Details - SYH2056 is a selective 5-HT2A receptor agonist that improves the condition of patients with depressive disorders by activating the receptor, showing rapid onset of action and prolonged efficacy without causing hallucinogenic risks [1] - The approved clinical indication for SYH2056 is for the treatment of depression, with preclinical studies demonstrating its effectiveness in promoting the generation of dendrites and dendritic spines in central nervous neurons, indicating a potential for neuroplasticity [1] - In various animal models of depression, SYH2056 exhibited excellent antidepressant activity while significantly reducing the potential hallucinogenic risks associated with the target, along with favorable pharmacokinetic (PK) properties and safety, positioning it as a potential best-in-class antidepressant [1] Group 2: Market Potential - Given the numerous clinical treatment inadequacies of traditional antidepressants and the lack of new mechanism drug therapies for depressive disorders, SYH2056 has a broad clinical demand and high clinical development value [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準 確性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產 生或因倚賴該等內容而引致的任何損失承擔任何責任。 選擇性5 -HT2A受體激動劑（SYH2056片） 在中國獲臨床試驗批准 該產品為一種選擇性5 -HT2A受體激動劑，通過激活該受體改善抑鬱障礙患者的疾病狀態， 單次給藥即可快速起效，藥效持久，且不產生致幻風險。本次獲批的臨床適應症為用於治 療抑鬱症。臨床前研究顯示，該產品可有效促進中樞神經元的樹突與樹突棘生成，具有促 進神經重塑作用。在多種抑鬱動物模型中，該產品表現出優異的抗抑鬱活性，並且極大地 降低了該靶點可能存在的致幻風險，同時具有良好的藥代動力學(PK)特性和安全性，使其 具備成為一款同類最優(best-in-class)抗抑鬱藥物的潛力。目前，本集團已在國內外提交了該 產品的多項專利申請。 – 1 – CSPC PHARMACEUTICAL GROUP LIMITED 石 藥 集 團 有 限 公 司 鑒於傳統抗抑鬱藥物存在較多無法克服的臨床治療不足，且抑鬱障礙缺乏新機制的藥物治 療，該產品的臨 ...

Core Insights - The article highlights the increasing prevalence of depression in China, with approximately 95 million individuals affected, leading to a booming market for antidepressant medications [5][12][18] - The demand for antidepressants has surged, with sales in public medical institutions exceeding 9.1 billion yuan in the previous year, marking a 6% year-on-year increase [5][7] - The market for antidepressants is becoming increasingly competitive, with numerous domestic pharmaceutical companies entering the space, particularly in the production of generic drugs [13][20] Market Dynamics - The rise in depression cases has created a vibrant pharmaceutical market, with companies like Hansoh Pharmaceutical and Jingwei Pharmaceutical achieving significant sales figures [7][12] - The sales of antidepressants in public hospitals have seen a drastic shift, with domestic companies gaining market share due to price reductions and increased competition [22][24] - The introduction of centralized procurement has led to a significant drop in drug prices, making antidepressants more accessible to patients [19][20][22] Industry Challenges - Despite the growing market, the high cost of psychological therapy remains a barrier for many patients, leading to a preference for medication over therapy [26][27] - The perception of antidepressants as a long-term necessity poses challenges for patient management, with many experiencing withdrawal symptoms when discontinuing medication [26][27] - The industry faces scrutiny over the quality of psychological counseling services, which can vary significantly, impacting patient experiences and outcomes [26][27]

Core Viewpoint - The article highlights the increasing prevalence of depression among the elderly population in China, emphasizing the need for greater awareness and treatment options for this demographic, which is often overlooked in discussions about mental health [4][5][7]. Group 1: Prevalence of Depression - According to the World Health Organization, the global depression rate is approximately 5%, with an estimated 10% to 15% among individuals aged 65 and older [4]. - A report indicates that 26.4% of elderly individuals in China exhibit varying degrees of depressive symptoms, with 6.2% experiencing moderate to severe depression [4]. - The detection rates of depression among elderly individuals vary significantly across different provinces in China, with Qinghai Province reporting the highest at 77.59% [8][12]. Group 2: Treatment and Awareness - Despite the high detection rates of depression among the elderly, the majority of patients seeking treatment at institutions like Anding Hospital are younger individuals [14]. - The current treatment rate for depression in China is only 9.5%, with a mere 0.5% of patients receiving adequate medication treatment [23]. - Many elderly patients, like Liu Liang, face challenges in seeking treatment due to family misconceptions about depression being a mere "mental issue" rather than a serious condition [16][24]. Group 3: Impact of Social Support - Social support plays a crucial role in alleviating depressive symptoms among the elderly, with economic and caregiving support being particularly effective [72][75]. - Rural elderly individuals benefit significantly from intergenerational support, which can lead to a more pronounced reduction in depressive symptoms compared to their urban counterparts [77]. - The lack of social interaction and engagement in activities contributes to the worsening of depressive symptoms among elderly individuals, highlighting the importance of community involvement and family connections [31][68]. Group 4: Treatment Challenges - The article discusses the complexities of medication adherence among elderly patients, with many reluctant to continue treatment due to side effects or misconceptions about their recovery [60][63]. - The recurrence rate of depression after discontinuing medication is alarmingly high, with estimates suggesting a 50% recurrence within two years [63]. - The narrative of patients like Wu Qun illustrates the potential dangers of stopping medication prematurely, leading to severe mental health crises [59]. Group 5: Societal Perception and Stigma - There is a prevailing stigma surrounding elderly depression, often dismissed as a natural part of aging, which complicates the recognition and treatment of the condition [66]. - The article emphasizes the need for societal change in how elderly depression is perceived, advocating for greater empathy and understanding towards affected individuals [88].