Core Viewpoint - The company has received approval from the National Medical Products Administration for the marketing application of the active pharmaceutical ingredient Agomelatine, which is primarily used for treating adult depression [1] Group 1: Company Information - The company involved is Guoyao Modern (国药现代), with its wholly-owned subsidiary Jiangsu Weichida Pharmaceutical Co., Ltd. (国药江苏威奇达) receiving the approval [1] - Agomelatine acts on melatonin receptors MT1 and MT2 and antagonizes 5-HT2C, helping to restore disrupted biological rhythms and exerting antidepressant effects [1] Group 2: Product Information - The clinical application of Agomelatine is mainly for the treatment of adult depression [1]

Core Viewpoint - The company, Stone Pharmaceutical Group, has received approval from the U.S. Food and Drug Administration (FDA) for its novel chemical entity, SYH2056, a selective 5-HT2A receptor agonist, to conduct clinical trials in the U.S. This product has also been approved by the National Medical Products Administration (NMPA) in China for clinical trials starting in November 2025 [1]. Group 1 - The product SYH2056 is designed to improve the condition of patients with depressive disorders by activating the 5-HT2A receptor, showing rapid onset of action with lasting effects and no risk of hallucinations [1]. - The clinical indication for SYH2056 is the treatment of depression, with preclinical studies demonstrating its effectiveness in promoting dendritic and dendritic spine generation in central nervous neurons, indicating 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, alongside favorable pharmacokinetic (PK) properties and safety, positioning it as a potential best-in-class antidepressant [1]. Group 2 - The clinical demand for SYH2056 is substantial due to the limitations of traditional antidepressants and the lack of new mechanism-based treatments for depressive disorders, highlighting its high clinical development value [1]. - The company has submitted multiple patent applications for SYH2056 both domestically and internationally, indicating a strong commitment to protecting its intellectual property [1].

Core Viewpoint - The announcement highlights that the pharmaceutical company has received approval from the U.S. Food and Drug Administration (FDA) for its novel Class 1 chemical drug, SYH2056, a selective 5-HT2A receptor agonist, to conduct clinical trials in the U.S. and has also received approval from the National Medical Products Administration (NMPA) in China for clinical trials starting in November 2025 [1] Group 1 - The product is designed to activate the 5-HT2A receptor to improve the condition of patients with depressive disorders, showing rapid onset of action and prolonged efficacy without the risk of hallucinations [1] - The clinical indication for the approved trials is the treatment of depression, with preclinical studies demonstrating effective promotion of dendritic and dendritic spine generation in central nervous neurons, indicating a potential for neuroplasticity [1] - In various animal models of depression, the product has shown 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 best-in-class antidepressant [1] Group 2 - The clinical demand for this product is substantial due to the numerous clinical treatment inadequacies of traditional antidepressants and the lack of new mechanism drug therapies for depressive disorders, indicating 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之內容概不負責，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之任何損失承擔任何責任。 CSPC PHARMACEUTICAL GROUP LIMITED 石 藥 集 團 有 限 公 司 （股份代號：1093） （於香港註冊成立之有限公司） 自願公告 選擇性5 -HT2A受體激動劑（SYH2056片） 在美國獲臨床試驗批准 石 藥 集 團 有 限 公 司（「 本 公 司 」， 連 同 其 附 屬 公 司 統 稱「 本 集 團 」）董 事 會（「 董 事 會 」）欣 然 宣 布， 本集 團開 發的 化藥 1 類新 藥選 擇性 5 -羥 色胺 2A 受體（「5 -HT2A 受體」）激 動劑（ SYH2056 片 ）（「該產品」）已獲得美國食品藥品監督管理局批准，可在美國開展臨床試驗。該產品亦已 於2025年11月獲得中華人民共和國國家藥品監督管理局批准在中國開展臨床試驗。 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 ...

Summary of Warner Pharmaceuticals Conference Call Company Overview - Warner Pharmaceuticals is primarily engaged in the integrated production and sales of chemical drugs and raw materials, focusing on digestive, respiratory, and anti-infection products. The company has faced significant impacts from centralized procurement policies, but is gradually moving out of the most negative phase of these impacts, with expectations of a turning point in the second half of 2025 [4][2]. Key Product Insights - The new antidepressant ZG001 targets the domestic market of approximately 95 million depression patients, addressing clinical pain points such as slow onset and low efficacy of existing medications. ZG001 is expected to be particularly effective in treating Major Depressive Disorder with Suicidal Ideation (MDSI) [2][5]. - ZG001 is currently in Phase 2A clinical trials, with data readout expected by the end of 2025 and Phase 2B trials starting in 2026. The drug aims for conditional market approval by 2027 [12][2]. Market Potential - The Chinese market for depression treatment is vast, with a significant number of patients suffering from severe depression and a high proportion exhibiting suicidal tendencies. The potential market for ZG001 is estimated to exceed 10 billion RMB if it successfully eliminates addictive side effects [3][13]. - The existing antidepressant market in China is growing rapidly, with a market size of approximately 700 million USD in 2020 and a double-digit growth rate expected [5]. Competitive Landscape - ZG001 differentiates itself from Johnson & Johnson's esketamine nasal spray by using a metabolite of ketamine, which retains rapid antidepressant effects while avoiding addictive side effects. This characteristic is crucial for acceptance among Chinese clinicians [11][14]. - The anticipated pricing for ZG001 is expected to be lower than that of Johnson & Johnson's product, which is priced around 8,000 USD for a four-week treatment course in overseas markets [13]. Financial Projections - Warner Pharmaceuticals anticipates an operating profit of approximately 200 million RMB for the year, although reported profits may fluctuate due to non-operating factors [2][4]. - The combined peak sales potential for ZG001 in the MDSI and treatment-resistant depression indications is projected to exceed 10 billion RMB, indicating substantial growth potential [16][18]. Future Outlook - The company is optimistic about ZG001's prospects in both domestic and potential overseas markets, with a total market capitalization growth potential exceeding 20 billion RMB if successful [17][18]. - The focus remains on the domestic market for the time being, given the current stage of clinical trials for ZG001 [17]. Conclusion - Warner Pharmaceuticals is positioned to capitalize on the growing demand for effective depression treatments in China, with ZG001 representing a significant opportunity to address unmet clinical needs while navigating the challenges posed by existing procurement policies and market competition [2][4][14].