该产品为一种选择性5-HT2A受体激动剂，通过激活该受体改善抑郁障碍患者的疾病状态，单次给药即 可快速起效，药效持久，且不产生致幻风险。本次获批的临床适应症为用于治疗抑郁症。临床前研究显 示，该产品可有效促进中枢神经元的树突与树突棘生成，具有促进神经重塑作用。在多种抑郁动物模型 中，该产品表现出优异的抗抑郁活性，并且极大地降低了该靶点可能存在的致幻风险，同时具有良好的 药代动力学(PK)特性和安全性，使其具备成为一款同类最优(best-in-class)抗抑郁药物的潜力。目前，集 团已在国内外提交了该产品的多项专利申请。 鉴于传统抗抑郁药物存在较多无法克服的临床治疗不足，且抑郁障碍缺乏新机制的药物治疗，该产品的 临床需求广阔，具有较高的临床开发价值。 智通财经APP讯，石药集团(01093)发布公告，集团开发的化药1类新药选择性5-羟色胺2A受体(5-HT2A 受体)激动剂(SYH2056 片)(该产品)已获得美国食品药品监督管理局批准，可在美国开展临床试验。该产 品亦已于2025年11月获得中华人民共和国国家药品监督管理局批准在中国开展临床试验。 ...

该产品为一种选择性5-HT2A受体激动剂，通过激活该受体改善抑郁障碍患者的疾病状态，单次给药即 可快速起效，药效持久，且不产生致幻风险。本次获批的临床适应症为用于治疗抑郁症。临床前研究显 示，该产品可有效促进中枢神经元的树突与树突棘生成，具有促进神经重塑作用。在多种抑郁动物模型 中，该产品表现出优异的抗抑郁活性，并且极大地降低了该靶点可能存在的致幻风险，同时具有良好的 药代动力学(PK)特性和安全性，使其具备成为一款同类最优(best-in-class)抗抑郁药物的潜力。目前，集 团已在国内外提交了该产品的多项专利申请。 鉴于传统抗抑郁药物存在较多无法克服的临床治疗不足，且抑郁障碍缺乏新机制的药物治疗，该产品的 临床需求广阔，具有较高的临床开发价值。 石药集团(01093)发布公告，集团开发的化药1类新药选择性5-羟色胺2A受体(5-HT2A受体)激动剂 (SYH2056片)(该产品)已获得美国食品药品监督管理局批准，可在美国开展临床试验。该产品亦已于 2025年11月获得中华人民共和国国家药品监督管理局批准在中国开展临床试验。 ...

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].