（股份代號：1093） （於香港註冊成立之有限公司） 自願公告 GLP -1 / GIP受體雙偏向性激動多肽注射液（SYH2069注射液） 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GLP -1 / GIP受體雙偏向性激動多肽注射液（ SYH2069注射液 ）（「該產品」）已 獲得美國食品藥品監督管理局(FDA)批准，可在美國開展臨床試驗。 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 – 1 – 本 次 獲 批 的 臨 床 適 應 症 為 肥 胖 或 超 重 合 併 至 少 一 種 體 重 相 關 合 併 症 人 群 的 體 重 管 理 。 此 外，該產品亦具備用於改善成人2型糖尿病(T2DM)患者的血 ...

Core Viewpoint - The company has received approval from the U.S. Food and Drug Administration (FDA) to conduct clinical trials for its Class 1 chemical drug, a selective 5-HT2A receptor agonist (SYH2056 tablets) [1] Group 1 - The product has also been approved by the National Medical Products Administration (NMPA) in China to conduct clinical trials starting from November 2025 [1]

Core Viewpoint - The approval of SYH2056 by the FDA for clinical trials in the U.S. marks a significant milestone for the company, indicating potential growth in the treatment of depression [1] Company Summary - The company, Shijiazhuang Yiling Pharmaceutical, has developed a new chemical drug, SYH2056, which is a selective 5-HT2A receptor agonist aimed at improving the condition of patients with depressive disorders [1] - SYH2056 has also received approval from the National Medical Products Administration in China to conduct clinical trials starting November 2025 [1] Product Details - SYH2056 is designed to provide rapid onset of action with lasting effects and does not carry the risk of inducing hallucinations [1] - The clinical indication for SYH2056 is specifically for the treatment of depression [1]

Core Viewpoint - The company has received approval from the U.S. Food and Drug Administration (FDA) for its Class 1 chemical drug, a selective 5-HT2A receptor agonist, to conduct clinical trials in the United States [1] Group 1 - The selective 5-HT2A receptor agonist is designed to improve the condition of patients with depressive disorders [1] - The drug shows rapid onset of action with a single dose and has a long-lasting effect without causing hallucinogenic risks [1] - The product has also been approved by the National Medical Products Administration (NMPA) of China to conduct clinical trials in China starting from November 2025 [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]

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]

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 ...

Core Insights - The Hong Kong Stock Connect Innovative Drug ETF (工银, 159217) experienced a net redemption of 2.867 million yuan on December 1, ranking 15th out of 198 in cross-border ETF net outflows [1] - As of December 1, the fund's latest size is 5.56 billion yuan, down from 5.59 billion yuan the previous day, with a net outflow accounting for 0.05% of the previous day's size [1] - Over the past 5 days, the fund faced a net redemption of 4.3125 million yuan, ranking 53rd out of 198 in cross-border ETF net outflows [1] - In the last 10 days, the fund saw a net subscription of 129 million yuan, ranking 34th out of 198 in cross-border ETF net inflows [1] - Over the past 20 days, the fund had a net subscription of 251 million yuan, ranking 36th out of 198 in cross-border ETF net inflows [1] Fund Details - The Hong Kong Stock Connect Innovative Drug ETF (工银, 159217) was established on March 26, 2025, with an annual management fee of 0.40% and a custody fee of 0.07% [1] - The fund tracks the Hong Kong Stock Connect Innovative Drug Index (987018) [1] - As of December 1, the fund's total shares are 3.865 billion, with a total size of 5.56 billion yuan [1] Liquidity and Performance - As of December 1, the fund's cumulative trading amount over the last 20 trading days is 13.981 billion yuan, with an average daily trading amount of 699 million yuan [2] - The current fund managers are Liu Weilin and Jiao Wenlong, with returns of 43.85% and 63.95% respectively since their management began [2] Top Holdings - The fund's top holdings include: - 百济神州 (10.84%, 314.54 million shares, 589 million yuan) - 康方生物 (10.77%, 454.20 million shares, 586 million yuan) - 信达生物 (10.43%, 644.10 million shares, 567 million yuan) - 中国生物制药 (9.82%, 7184.50 million shares, 534 million yuan) - 石药集团 (7.72%, 4908.40 million shares, 420 million yuan) - 三生制药 (7.41%, 1469.60 million shares, 403 million yuan) - 翰森制药 (5.50%, 908.20 million shares, 299 million yuan) - 科伦博泰生物-B (3.55%, 41.14 million shares, 193 million yuan) - 再鼎医药 (2.79%, 621.62 million shares, 151 million yuan) [2] Comparative Analysis - Other ETFs tracking the Hong Kong Stock Connect Innovative Drug Index include: - 汇添富国证港股通创新药ETF (159570) with a size of 23.978 billion yuan and a recent average daily trading amount of 2.652 billion yuan [2] - 港股创新药ETF (159567) with a size of 8.460 billion yuan and a recent average daily trading amount of 1.457 billion yuan [2] - 南方国证港股通创新药ETF (159297) with a size of 1.459 billion yuan and a recent average daily trading amount of 0.115 billion yuan [2] - 鹏华国证港股通创新药ETF (159286) with a size of 0.607 billion yuan and a recent average daily trading amount of 0.088 billion yuan [2]

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | 截至月份: | 2025年11月30日 | 狀態: 新提交 | | --- | --- | --- | | 致：香港交易及結算所有限公司 | | | | 公司名稱: | 石藥集團有限公司 | | | 呈交日期: | 2025年12月1日 | | | I. 法定/註冊股本變動 | 不適用 | | II. 已發行股份及/或庫存股份變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01093 | 說明 | | | | | | | | | 已發行股份（不包括庫存股份）數目 | | 庫存股份數目 | | 已發行股份總數 | | | 上月底結存 | | | 11,522,451,732 | | 0 | | 11,522,451,732 | | 增加 / 減少 (-) | | | 0 | | 0 | | | | 本月底結存 | | | 11,522 ...