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石药集团(01093):SYH2070注射液(双链小干扰RNA药物)在美国获临床试验批准
智通财经网· 2025-10-09 10:15
Core Viewpoint - The approval of SYH2070 injection by the FDA marks a significant milestone for the company, enabling clinical trials in the U.S. and highlighting the potential of the drug in treating hypertriglyceridemia and mixed dyslipidemia [1] Group 1: Product Development - The SYH2070 injection is a first-class new chemical drug developed by the company, utilizing double-stranded small interfering RNA (siRNA) technology [1] - The drug targets ANGPTL3 to effectively lower its levels, which is crucial for managing triglyceride levels [1] - The product has also received approval from the National Medical Products Administration (NMPA) in China for clinical trials, expected to commence in September 2025 [1] Group 2: Mechanism and Efficacy - SYH2070 employs GalNAc for liver-targeted delivery, allowing for subcutaneous administration [1] - The drug demonstrates superior drug activity and prolonged efficacy compared to similar siRNA products, indicating a longer-lasting gene silencing effect [1] - Clinical pre-research shows that SYH2070 has differentiated advantages in terms of safety, patient compliance, and sustained drug action [1] Group 3: Market Potential - The drug is positioned to potentially reduce the risk of elevated residual cholesterol levels, making it a valuable candidate for clinical development in the relevant therapeutic areas [1]
石药集团(01093.HK)SYH2070注射液(双链小干扰RNA药物)在美国获临床试验批准
Ge Long Hui· 2025-10-09 10:11
Core Viewpoint - The company, Stone Pharmaceutical Group, has received FDA approval for its self-developed chemical new drug SYH2070 injection, a dual-strand siRNA drug, allowing it to conduct clinical trials in the United States. The drug is also set to receive approval from China's National Medical Products Administration for clinical trials by September 2025 [1]. Group 1: Product Details - SYH2070 is designed for liver-targeted delivery using GalNAc conjugation, administered subcutaneously to target ANGPTL3, effectively lowering its levels [1]. - The drug employs optimized sequences and chemical modifications to achieve prolonged gene silencing effects, positioning it as a long-acting siRNA drug for treating hypertriglyceridemia or mixed dyslipidemia, with potential to reduce the risk of elevated residual cholesterol levels [1]. Group 2: Clinical Research Insights - Preclinical studies indicate that SYH2070 outperforms similar siRNA products in terms of drug activity and efficacy duration, showcasing advantages such as sustained drug effects, good safety profile, and high patient compliance, highlighting its significant clinical development value [1].
石药集团(01093) - 自愿公告 - SYH2070注射液(双链小干扰RNA药物)在美国获临床试...
2025-10-09 10:01
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份內容而產 生或因倚賴該等內容而引致之任何損失承擔任何責任。 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 佈 , 本 集 團 自 主 研 發 的 化 學 1 類 新 藥 SYH2070 注 射 液( 雙 鏈 小 干 擾 RNA(「 si RNA 」)藥 物 ) (「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 亦於2025年9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 藥的方式靶向血管生成素樣蛋白3(「ANGPTL3」),能有效降低ANGPTL3水平。通過優化序 列和化學修飾的策略,該產品實現更持久的基因沉默效果,有望成為超長效降低ANGPTL3 的si RNA藥物,適用 ...
中金:看好创新药长期产业发展趋势 期待商保突破
Zhi Tong Cai Jing· 2025-10-09 08:09
Core Viewpoint - The domestic innovative drug industry is transitioning from a follower to FIC/BIC innovation, supported by engineer dividends, abundant clinical resources, and favorable policies, indicating a qualitative improvement as it enters the 2.0 era [1][2] Group 1: Industry Development - The innovative drug sector is expected to benefit from policy reforms in payment systems, enhancing the profitability of innovative drug companies as they commercialize domestic products [2] - The upcoming ESMO conference in mid-October is anticipated to provide new investment opportunities through the release of relevant clinical data and business development (BD) activities [2] Group 2: Investment Climate - The investment landscape has improved since early this year, with a notable reversal in the financing trend for the innovative drug industry, particularly in the A/H market [3] - The recovery of IPO projects and financing activities in the secondary market is expected to positively impact investment data in Q3, benefiting domestic CROs and upstream research sectors [3] Group 3: Policy Support - Continuous advancement of commercial medical insurance policies since 2025 is likely to accelerate payment system reforms, easing supply-demand conflicts and supporting domestic innovation [4] - Fiscal policy enhancements are expected to increase market interest in domestic medical equipment stocks [4] Group 4: Target Companies - A-share targets include: BeiGene (688235.SH), Hengrui Medicine (600276.SH), Kelun Pharmaceutical (002422.SZ), WuXi AppTec (603259.SH), Tigermed (300347.SZ), New Industry (300832.SZ), BGI Genomics (688114.SH), Huatai Medical (688617.SH), and Dian Diagnostics (300244.SZ) [5] - H-share targets include: Kelun Biotech (06990), CSPC Pharmaceutical (01093), China Biologic Products (01177), CanSino Biologics (09926), WuXi Biologics (02269), Junshi Biosciences (01877), and Zai Lab (09688) [5]
港股石药集团股价跌幅扩大至5.0%
Mei Ri Jing Ji Xin Wen· 2025-10-09 02:45
每经AI快讯,10月9日,港股石药集团股价表现疲弱,跌幅扩大至4.99%,现价报9.33港元,总市值 1075.04亿港元。今年以来,公司股价累计上涨97.71%。 ...
医药集采“里程碑”转向 深入挖掘“反内卷”机遇
Sou Hu Cai Jing· 2025-10-08 12:05
Core Viewpoint - The National Healthcare Security Administration has announced the 11th batch of centralized drug procurement, which will take place on October 21, covering 55 varieties and 162 specifications, including key areas such as antiviral and kidney disease treatment drugs [1][2]. Group 1: Drug Procurement Policy - The 11th batch of centralized procurement aims to stabilize clinical practices, ensure quality, prevent collusion, and avoid excessive competition [1]. - The new procurement rules will optimize price control mechanisms to prevent companies from underbidding, which previously led to unsustainable low prices [1][4]. - The focus on high-value consumables and medical devices is expected to benefit companies with strong cost advantages and product quality, particularly in major categories like cardiovascular and anti-infection drugs [4][5]. Group 2: Market Opportunities and Challenges - The centralized procurement policy presents both opportunities and challenges for pharmaceutical companies, prompting some generic drug firms to shift towards a combination of generics and innovation [2][5]. - The "anti-involution" trend in the procurement sector is expected to primarily benefit high-value consumables, which have been adversely affected by previous procurement rounds [2][4]. Group 3: Long-term Investment Perspective - Investors are advised to adopt a long-term perspective, as some innovative drug stocks are currently overvalued following previous market enthusiasm [3][9]. - The ongoing improvement of procurement policies is seen as a catalyst for the healthy development of the pharmaceutical industry, favoring large innovative drug companies with strong R&D capabilities [5][9]. Group 4: Company Performance and Projections - Companies like Kelun Pharmaceutical, Jingxin Pharmaceutical, and Fosun Pharma are highlighted for their strong R&D pipelines and potential for growth, with Kelun having over 30 projects focused on oncology [6][7]. - Fosun Pharma has made significant progress in its innovative transformation, with multiple products showing promising clinical trial results [6][8]. - China National Pharmaceutical Group is expected to have nearly 20 innovative products approved in the next three years, with several projected to exceed sales of 2 billion RMB [8].
主席兼执行董事蔡东晨增持石药集团200万股 每股作价约9.65港元
Zhi Tong Cai Jing· 2025-10-06 11:40
香港联交所最新资料显示,10月6日,主席兼执行董事蔡东晨增持石药集团(01093)200万股,每股作价 为9.645港元,总金额为1929万港元。增持后最新持股数目约为28.37亿股,最新持股比例为24.62%。 ...
主席兼执行董事蔡东晨增持石药集团(01093)200万股 每股作价约9.65港元
智通财经网· 2025-10-06 11:35
智通财经APP获悉,香港联交所最新资料显示,10月6日,主席兼执行董事蔡东晨增持石药集团 (01093)200万股,每股作价为9.645港元,总金额为1929万港元。增持后最新持股数目约为28.37亿股, 最新持股比例为24.62%。 ...
智通港股股东权益披露|10月6日
智通财经网· 2025-10-06 00:12
智通财经APP获悉,狮子山集团(01127)、石药集团(01093)于2025年10月6日进行了最新股东权益披露。 备注:持股数变动有可能因供股、合股、拆股等情况引起,请注意对照实际情况进行辨别。 | 股票名称 | 机构名称 | 性质 | 变动前持股 | 变动后持股 | 持股比 | | --- | --- | --- | --- | --- | --- | | 狮子山集团 | 刘竹坚 | 好仓 | 3.60 亿股 | 3.62 亿股 | 46.99%(最新) | | (01127) | | | | | 46.70%(前次) | | 石药集团(01093) | 蔡东晨 | 好仓 | 28.34 亿股 | 28.35 亿股 | 24.61%(最新) | | | | | | | 24.59%(前次) | ...
石药集团(01093.HK)获执行董事兼主席蔡东晨增持725.4万股
Ge Long Hui· 2025-10-05 23:18
| 股份代號: | 01093 | | --- | --- | | 上市法國名稱: | 石藥集國有限公 | | 日期 (日 / 月 / 年): | 06/09/2025 - 06 | 格隆汇10月6日丨根据联交所最新权益披露资料显示,2025年10月2日-10月3日,石药集团(01093.HK)获执行董事兼主席蔡东晨在场内以每股均价9.6238- 9.6383港元合计增持725.4万股,涉资约6989.8万港元。 增持后,蔡东晨最新持股数目为2,835,118,670股,持股比例由24.54%上升至24.61%。 | 表格序號 | 大股東/董事/最高行政人員名稱 作出披露的 買入 / 賣出或涉及的股每股的平均價 | | | | | 持有權益的股份數目 佔已發行的 有關事件的日 | | | --- | --- | --- | --- | --- | --- | --- | --- | | | | 原大 | 份數目 | | | (請參閱上述*註解)有投票權股 (日 / 月 / 年) | | | | | | | | | 份自分比 | | | | | | | | | ( % ) | | | DA20251003E00 ...