近日（10月28日），据摩熵医药数据库（https://vip.pharnexcloud.com/?zmt-mhwz）-中国药品审评数据库显示，石药集团的化药1类新药SYH2070注射液获 得临床试验默示许可，拟用于高脂血症。 | 按受理号浏览(22) | 按品种浏览(16) | 按企业浏览(5) | 项目进度(16) 2 | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 受理号 | 药品名称 | 药品名称(摩熵) | 单方/复方 | 药品类型 | 剂型 | CDE企业名称 | 申请类型 | | CXSL2500654 | SYS6002 | SYS-6002 | 单组分 | 治疗用生 | 注射剂 | 石药集团巨石生物制药有限公司 | 新药 | | | | | | 物制品 | | | | | CXSL2500656 | SYS6043 | SYS-6043 | 单组分 | 治疗用生 | 注射剂 | 石药集团巨石生物制药有限公司 | 新药 | | | | | | 物制品 | | | | | CXSL2500658 | SYS6010 | ...

Major Events - MIRXES-B (02629) received approval from the National Medical Products Administration of China for the GASTROClear™ IVD registration certificate for gastric cancer screening [1] - JD Logistics (02618) plans to acquire JD Group's local instant delivery service business for $270 million to enhance "last mile" delivery capabilities [1] - HSBC Holdings (00005) intends to privatize Hang Seng Bank (00011) [1] - Fuhong Hanlin (02696) reported that the phase III clinical study of Hansu® (sulizumab injection) in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer achieved its primary endpoint [1] - WuXi AppTec (02126) announced that the National Medical Products Administration officially accepted the supplementary application for the post-marketing use of Benodda® with a domestic viral vector [1] - Sunny Optical (02382) plans to transfer approximately 1.903 billion yuan to Shanghai Aolai and invest in GoerTek to jointly develop AI/AR optical business [1] - CSPC Pharmaceutical Group (01093) received clinical trial approval for SYH2070 injection (double-stranded small interfering RNA drug) in the United States [1] - Yanda Pharmaceutical (00512) completed patient enrollment for the registration clinical study of a globally innovative temperature-sensitive embolic agent in China [1] - CloudWalk Technology (09678) successfully won bids for multiple intelligent agent projects, including the AI capability platform for Beijing Friendship Hospital [1] - Huakang Biomedical (08622) received a cash offer from Anselme Limited to acquire 27.71% of its shares at a discount of approximately 68.10%, with resumption of trading on October 10 [1] Operating Performance - Baolong Properties (01238) reported a total contracted sales of approximately 5.431 billion yuan in the first nine months, a year-on-year decrease of 43.64% [2] - Fast Retailing (06288) released its annual performance, with a net profit attributable to shareholders of 433.009 billion yen, a year-on-year increase of 16.4%, with trading resuming on October 10 [2] - Jingrui Holdings (01862) reported a contracted sales amount of 740 million yuan in the first nine months, a year-on-year decrease of 49.52% [2] - Dongfeng Motor Group (00489) recorded cumulative automobile sales of 1.3168 million units in the first nine months, a year-on-year decline of approximately 3.6% [2] - Yaoshi Bang (09885) reported a total transaction volume of approximately 658.4 million yuan for its brand promotion business in the third quarter, a year-on-year increase of 163% [2]

Company News - Sunny Optical Technology (02382.HK) plans to transfer Shanghai Aolai for approximately 1.903 billion yuan and invest in GoerTek to jointly develop AI/AR optical business [2] - Orient Overseas International (00316.HK) reported a 8.3% decrease in shipping revenue for the first nine months, totaling approximately 6.696 billion USD, with an overall load factor down 1.5% and average revenue per standard container down 12.4% compared to the same period last year [2] - Xiehe New Energy (00182.HK) reported a 0.31% decrease in equity power generation for the first nine months, totaling 6,464.54 GWh, while solar equity power generation increased by 30.69% year-on-year [2] - Fast Retailing (06288.HK) announced annual results for the year ending August 31, 2025, with revenue of 3.400539 trillion yen, a year-on-year increase of 9.6%, and net profit of 433.009 billion yen, up 16.4% [3] - Dongfeng Motor Group (00489.HK) reported cumulative vehicle sales of 1.3168 million units for the first nine months, a year-on-year decline of approximately 3.6% [4] - Gemdale Property (00535.HK) reported a cumulative contract sales amount of approximately 8.533 billion yuan for the first nine months, a year-on-year decrease of 39.81% [4] - Baolong Real Estate (01238.HK) reported a contract sales total of approximately 5.431 billion yuan for the first nine months, down 43.64% year-on-year [4] - Zhengrong Real Estate (06158.HK) reported a cumulative contract sales amount of approximately 3.288 billion yuan for the first nine months, a year-on-year decrease of 32.8% [4] - JINGRUI Holdings (01862.HK) reported a contract sales amount of 740 million yuan for the first nine months, a year-on-year decrease of 49.52% [5] - China Wisdom Energy (01004) withdrew its liquidation petition [5] Shareholding Changes - Flat Glass Group (06865.HK) saw some shareholders and directors reduce their holdings by a total of 29.9803 million shares [6] - CNOOC Services (02883.HK) reported that its controlling shareholder, China National Offshore Oil Corporation, increased its holdings by 16.008 million H-shares over the past six months [6] - China National Offshore Oil Corporation (00883.HK) reported that its actual controller increased its holdings by 22.098 million shares in the past six months [6] - Tencent Holdings (00700.HK) repurchased 816,000 shares at a cost of 551 million HKD, with repurchase prices ranging from 666 to 680.5 HKD [6]

Core Insights - The company Shiyao Group (01093) has received FDA approval for its self-developed chemical Class 1 new drug SYH2070 injection, a double-stranded small interfering RNA (siRNA) drug, allowing clinical trials in the United States [1] - The product has also been approved by the National Medical Products Administration of China to conduct clinical trials in China starting September 2025 [1] Product Details - SYH2070 is designed for liver-targeted delivery of siRNA through the conjugation of N-acetylgalactosamine (GalNAc), administered subcutaneously to target angiopoietin-like protein 3 (ANGPTL3), effectively lowering ANGPTL3 levels [1] - The drug aims to provide a long-lasting gene silencing effect, potentially serving as an ultra-long-acting siRNA drug for treating hypertriglyceridemia or mixed hyperlipidemia, with the ability to reduce the risk of elevated residual cholesterol levels [1] Clinical Research Findings - Preclinical studies indicate that SYH2070 demonstrates superior drug activity and efficacy duration compared to similar siRNA products, showcasing prolonged drug effects, good safety profiles, and high patient compliance, highlighting its significant clinical development value [1]

Core Viewpoint - The company has received FDA approval for its self-developed chemical Class 1 new drug SYH2070 injection, a double-stranded small interfering RNA (siRNA) drug, allowing it to conduct clinical trials in the United States [1] Group 1 - The drug SYH2070 injection has also been approved by the National Medical Products Administration (NMPA) of China to conduct clinical trials starting from September 2025 [1]

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]

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].

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 ...

Major Events - Jinye International Group (08549) plans to issue 100 million shares from September 30 to October 6 [1] - Zhida Technology (02650) intends to globally issue 5.9789 million shares, expecting to list on October 10 [1] - CSPC Pharmaceutical Group (01093) received clinical trial approval for SYH2070 injection (double-stranded small interfering RNA drug) in China [1] - Mixue Group (02097) plans to invest in a fresh beer product company to seize opportunities in the fresh beer industry [1] - Shangshan Gold (01939) proposes a placement at a discount of approximately 19.88%, aiming to raise about HKD 245.8 million [1] - GC Construction (01489) sees a change in controlling interest with a buyout offer at a discount of about 45.91%, resuming trading on October 2 [1] - Times Financial Services Group (00510) major shareholder plans to sell some shares, resuming trading on October 2 [1] - Huajian Medical (01931) confidentially submitted an F-1 registration statement for a dual listing in the U.S. [1] - Ding Shi Capital (00804) intends to acquire 100% equity of a distressed asset disposal business, actively entering the distressed asset market [1] - Chuangmeng Tiandi (01119) plans to issue a total of 236 million shares [1] - Zhaogang Group-W (06676) intends to conduct a share buyback [1] - Daren International (01957) is exploring the possibility of acquiring up to 100 bitcoins [1] - Sihuan Pharmaceutical (00460) received approval from the National Medical Products Administration for its self-developed L-carnosine composite solution water light needle "Frozen Beauty" [1] Bonds and Notes - Minmetals Resources (01208) plans to issue USD 500 million zero-coupon convertible bonds maturing in 2030 [2] Share Buybacks - Tencent Holdings (00700) repurchased approximately 832,000 shares for about HKD 551 million on September 30 [2] - Midea Group (00300) spent approximately CNY 146 million to repurchase 2.0015 million A-shares on September 30 [2] - Anta Sports (02020) repurchased approximately 1.000 million shares for about HKD 99.87 million on September 30 [2] - SF Holding (06936) repurchased approximately 937,600 A-shares for about CNY 37.78 million on September 30 [2] - HSBC Holdings (00005) repurchased approximately 2.1133 million shares for about GBP 22.07 million on September 29 [2] Operating Performance - BYD Company (01211) reported approximately 3.2601 million new energy vehicle sales in the first nine months, a year-on-year increase of 18.64% [2] - Geely Automobile (00175) reported total vehicle sales of 273,100 units in September, a year-on-year increase of approximately 35% [2] - Great Wall Motors (02333) reported total vehicle sales of approximately 133,600 units in September, a year-on-year increase of 23.29% [2] - NIO Inc. (09866) delivered 34,749 vehicles in September, setting a new monthly record with a year-on-year increase of 64.1% [2] - Li Auto (02015) delivered 33,951 new vehicles in September [2]

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 血管生成素样蛋白3(ANGPTL3)，能有效降低ANGPTL3水平。通过优化序列和化学修饰的策略，该产 品实现更持久的基因沉默效果，有望成为超长效降低ANGPTL3的siRNA药物，适用于治疗高甘油三酯 血症或混合型高脂血症，具备有效降低残余胆固醇水平升高风险的潜力。 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。 石药集团(01093)发布公告，集团自主研发的化学1类新药SYH2070注射液(双链小干扰RNA(siRNA)药物) (该产品)已获得中华人民共和国国家药品监督管理局批准，可在中国开展临床试验。 ...