香港联交所最新资料显示，11月24日，主席兼执行董事蔡东晨增持石药集团(01093)1486.6万股，每股作 价7.4608港元，总金额约为1.11亿港元。增持后最新持股数目约为28.87亿股，最新持股比例为25.06%。 ...

智通财经APP获悉，香港联交所最新资料显示，11月24日，主席兼执行董事蔡东晨增持石药集团 (01093)1486.6万股，每股作价7.4608港元，总金额约为1.11亿港元。增持后最新持股数目约为28.87亿 股，最新持股比例为25.06%。 ...

石药集团(01093)发布公告，集团自主研发的化学1类新药双链小干扰RNA药物(SYH2061注射液)已获得 美国食品药品监督管理局(FDA)批准，可在美国开展临床试验。该产品亦已于2025年10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。 临床前研究显示，该产品在药物活性和药效持续性方面均优于同类型siRNA产品，展现出药物作用效果 持久、安全性良好、患者依从性高等差异化优势，具有较高的临床开发价值。 该产品是一款通过偶联乙醯半乳糖胺(GalNAc)实现肝脏靶向递送的siRNA药物，以皮下给药的方式靶向 补体蛋白C5，能有效降低C5水平。通过优化序列和化学修饰的策略，该产品可实现更持久的基因沉默 效果，是国内自主研发并进入临床试验阶段的首款超长效降低C5水平的siRNA药物，适用于治疗IgA肾 病及其他补体介导相关性疾病。 ...

Core Viewpoint - The company, Stone Pharmaceutical Group, has received FDA approval for its self-developed chemical class 1 new drug, SYH2061 injection, which is set to enter clinical trials in the United States. The drug has also been approved by the National Medical Products Administration of China for clinical trials starting in October 2025 [1]. Group 1 - The drug is a siRNA medication that utilizes GalNAc for targeted delivery to the liver, aiming to reduce complement protein C5 levels effectively [1]. - SYH2061 is the first domestically developed ultra-long-acting siRNA drug targeting C5 to enter clinical trials, indicating significant progress in the treatment of IgA nephropathy and other complement-mediated diseases [1]. - Preclinical studies demonstrate that SYH2061 outperforms similar siRNA products in terms of drug activity and efficacy duration, showcasing its long-lasting effects, good safety profile, and high patient compliance [1].

Core Viewpoint - The company, Stone Pharmaceutical Group, has received FDA approval for its self-developed siRNA drug SYH2061 injection, allowing clinical trials in the U.S. This drug is also approved for clinical trials in China starting October 2025 [1] Group 1: Product Details - SYH2061 is a first-in-class siRNA drug that targets complement protein C5 through GalNAc conjugation for liver-targeted delivery [1] - The drug is administered subcutaneously and is designed to effectively lower C5 levels, making it suitable for treating IgA nephropathy and other complement-mediated diseases [1] Group 2: Clinical Development - This product is the first domestically developed siRNA drug to enter clinical trials in China with a long-lasting effect on reducing C5 levels [1] - Preclinical studies indicate that SYH2061 outperforms similar siRNA products in terms of drug activity and duration of effect, showcasing its potential 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 雙鏈小干擾RNA藥物（SYH2061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，本集團自主研發的化學1類新藥雙鏈小干擾RNA（「si RNA」）藥物（ SYH2061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。 該 產 品亦 已 於2025年10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。 該產品是一款通過偶聯乙醯半乳糖胺(Gal NAc)實現肝臟靶向遞送的si RNA 藥物，以皮下給 藥的方式 ...

Core Insights - The article discusses the recent clinical trial applications submitted by several pharmaceutical companies, focusing on the competitive landscape of PD-1 inhibitors in the oncology market [12][11]. Group 1: New Drug Applications - From June 13 to June 18, the National Medical Products Administration received applications for 9 new chemical and biological drugs from 6 listed companies [4]. - Companies such as Hengrui Medicine, Innovent Biologics, and CSPC Pharmaceutical Group submitted 2 clinical applications each, while companies like Ascletis Pharma, Junshi Biosciences, and Kintor Pharmaceutical submitted 1 application each [7]. Group 2: Focus on Oncology Drugs - All applications during this period were for anti-tumor drugs, indicating a strong focus on oncology within the pharmaceutical industry [8]. - The article highlights that the PD-1 inhibitors submitted by Shijiazhuang Yiling Pharmaceutical and Junshi Biosciences are still in clinical trials, with no products yet on the market [12]. Group 3: Competitive Landscape - Currently, there are 8 PD-1/PD-L1 products approved in China, leading to intense competition among companies [12]. - Shijiazhuang Yiling's PD-1 is in Phase I clinical trials for ovarian cancer and Phase II for advanced/metastatic cervical cancer, while Junshi's PD-1 is at the application stage for MSI-H solid tumors [12][13]. - The article suggests that both companies need to adopt differentiated development strategies to avoid excessive competition and achieve market success [12]. Group 4: Market Positioning - Junshi's PD-1, known as Surulitinib, is positioned to be the first anti-PD-1 monoclonal antibody for treating MSI-H solid tumors in China, despite its later market entry [12]. - In contrast, Shijiazhuang Yiling's prospects for its PD-1 product appear less optimistic, as there are no approved PD-1 products for cervical cancer in the domestic market [13]. Group 5: Historical Context - Shijiazhuang Yiling previously had a partnership with Junshi Biologics for a PD-1 product but terminated the agreement to avoid potential conflicts with another in-house PD-1 candidate [14]. - This decision has led to a delay in Shijiazhuang Yiling's PD-1 development, while Junshi's product has been on the market for over two years, generating significant revenue [14].

华泰证券发表报告指，石药集团首三季收入198.9亿元，按年跌12.3%；净利润35.1亿元，按年跌7.1%。 公司第三季收入重回增长，主因成药业务剔除授权收入降幅缩窄，多美素集采影响逐步消散；利润为 9.6亿元，该行估测近6亿元内生利润。 展望第四季，该行看好奥马珠/铭覆乐等新品持续市场开拓背景下，公司收入端按季持续改善。考虑 EGFR ADC重磅出海潜力、公司其他技术平台BD机会及潜在重磅管线数据读出，该行维持对其"买 入"评级。 该行将公司2025至2027年净利润预期分别由57.53亿、57.83亿及67.71亿元，下调至45.52亿、46.28亿及 50.29亿元；目标价由16.48港元降至12.75港元。 ...

华泰证券发表报告指，石药集团首三季收入198.9亿元，按年跌12.3%；净利润35.1亿元，按年跌7.1%。 公司第三季收入重回增长，主因成药业务剔除授权收入降幅缩窄，多美素集采影响逐步消散；利润为 9.6亿元，该行估测近6亿元内生利润。展望第四季，该行看好奥马珠/铭覆乐等新品持续市场开拓背景 下，公司收入端按季持续改善。考虑EGFR ADC重磅出海潜力、公司其他技术平台BD机会及潜在重磅 管线数据读出，该行维持对其"买入"评级。该行将公司2025至2027年净利润预期分别由57.53亿、57.83 亿及67.71亿元，下调至45.52亿、46.28亿及50.29亿元；目标价由16.48港元降至12.75港元。 ...

Core Viewpoint - The report from CMB International indicates that the revenue of CSPC Pharmaceutical Group in the third quarter was 6.62 billion yuan, slightly below expectations, but showed significant improvement compared to the second quarter, with a more pronounced recovery expected in the fourth quarter [1] Revenue and Growth Forecast - The management anticipates a return to positive growth by 2026, driven by key new products such as Mingfule, Irinotecan Liposome, and biosimilars (Omalizumab and the upcoming Pertuzumab) [1] - By 2027, growth expectations are expected to become clearer as the impact of centralized procurement dissipates [1] Research and Development - As the innovative pipeline progresses into late-stage clinical development, R&D expenses are projected to increase rapidly [1] Financial Adjustments - Based on the third-quarter performance and management outlook, the revenue forecasts for 2025 to 2027 have been reduced by 5% to 8%, and net profit forecasts have been lowered by 16% to 21% [1] - The target price has been adjusted to 7.3 HKD, with the company facing both positive catalysts and risks in the short term, leading to a reasonable stock valuation and a "Neutral" rating [1]