Core Viewpoint - The approval of SYH2066 by the National Medical Products Administration of China for clinical trials marks a significant milestone for the company, potentially positioning it as a leader in the treatment of respiratory syncytial virus (RSV) infections [1] Company Summary - The stock price of the company, 石药集团 (Stone Pharmaceutical Group), increased by over 3%, currently trading at 10.58 HKD with a transaction volume of 526 million HKD [1] - The company has developed SYH2066, a new oral small molecule candidate drug targeting RSV, which has shown promising pharmacokinetic properties and safety in preclinical studies [1] - There are currently no targeted small molecule drugs for RSV available in the domestic and international markets, indicating a high clinical development value for SYH2066 [1] Industry Summary - The approval of SYH2066 for clinical trials addresses a significant unmet medical need in the treatment of RSV, a common cause of respiratory infections [1] - The potential introduction of an effective treatment for RSV could impact the pharmaceutical landscape, particularly in the respiratory disease segment [1]

Major Events - China Power (02380) plans to acquire a 31% stake in Dazhou Energy [1] - Shun Teng International Holdings (00932) received a 20% discount from Chairman Zhang Shaohui for a full acquisition offer [1] - Huajian Medical (01931) established a joint venture to deepen the global blockchain financial ecosystem strategy through the "ETHK" core brand [1] - Derin Holdings (01709) signed a strategic cooperation and investment agreement with Winner Fashion (03709) [1] - Dongwu Cement (00695) major shareholder Goldview intends to sell a total of 204 million shares, making Hong Kong Aviation the single largest shareholder [1] - CSPC Pharmaceutical Group (01093) received clinical trial approval for SYH2066 tablets in China [1] - GAC Group (02238) plans to issue up to 15 billion yuan in corporate bonds and 15 billion yuan in medium-term notes [1] - Huatai Securities (06886) plans to issue up to 6 billion yuan in corporate bonds [1] - Ark Health (06086) stated that the H2H conference news is not insider information and is unaware of the reason for the stock price increase [1] Financial Data - China Resources Land (01109) reported a cumulative contract sales amount of 136.8 billion yuan for the first eight months, a year-on-year decrease of 12.0% [1] - Yuexiu Property (00123) reported a cumulative contract sales amount of approximately 73.011 billion yuan for the first eight months, a year-on-year increase of approximately 3.7% [1] - Zhong An Online (06060) reported a total original insurance premium income of approximately 23.625 billion yuan for the first eight months, a year-on-year increase of 6.36% [1]

Core Viewpoint - The announcement indicates that the product SYH2066, developed by the company, has received approval from the National Medical Products Administration of China to conduct clinical trials for treating respiratory infections caused by RSV [1] Company Summary - SYH2066 is a novel oral small molecule candidate drug targeting respiratory syncytial virus (RSV) and is classified as a chemical class 1 new drug [1] - The approved indication for SYH2066 is for the treatment of respiratory infections caused by RSV [1] - Preclinical studies have shown that the product has good oral bioavailability and pharmacokinetic properties, significantly reducing RSV viral load in disease animal models while demonstrating high safety [1] Industry Summary - Currently, there are no small molecule drugs targeting RSV available in the domestic and international markets [1] - The potential of SYH2066 to become an effective treatment for RSV infections suggests a high clinical development value for the product [1]

Core Viewpoint - The company Shiyao Group has received approval from the National Medical Products Administration of the People's Republic of China for its self-developed drug SYH2066, which targets respiratory syncytial virus (RSV) and is set to enter clinical trials in China by September 2025 [1] Company Summary - SYH2066 is a new chemical entity classified as a Class 1 new drug, specifically designed as an oral small molecule candidate for treating respiratory infections caused by RSV [1] - The drug has demonstrated good oral bioavailability and favorable pharmacokinetic properties in preclinical studies, significantly reducing RSV viral load in animal models while showing high safety [1] - Currently, there are no targeted small molecule drugs for RSV available in the domestic and international markets, positioning SYH2066 as a potentially effective treatment with high clinical development value [1] Industry Summary - The approval of SYH2066 marks a significant advancement in the treatment options for RSV, a disease that currently lacks targeted small molecule therapies [1] - The development of this drug could address a critical gap in the market, potentially leading to improved patient outcomes and establishing a new standard of care for RSV infections [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的內容概不負責，對其準 確性或完整性亦不發表任何聲明，並明確表示概不就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的任何損失承擔任何責任。 該產品為本集團自主研發的化學1類新藥，是一款作用於呼吸道合胞病毒（「RSV」）的新型口 服小分子候選藥物。本次獲批的適應症為用於治療由RSV引起的呼吸道感染（「該疾病」）。 臨床前研究表明，該產品具備良好的口服生物利用度等藥代動力學性質，並在疾病動物模 型中能顯著降低RSV病毒滴度，且安全性較高。 目前，國內外尚無靶向RSV的小分子藥物上市。該產品有望成為針對該疾病的有效治療藥 物，具有較高的臨床開發價值。 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 SYH2066片在中國獲臨床試驗批准 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 佈，本集團開發的SYH2066片（「該產品」）已於2025年9月獲中華人民共和國國家藥品監督管 理局批准，可在中國開展臨 ...

Market Overview - On September 11, the Hang Seng Index fell by 0.43%, closing at 26,086.32 points, while southbound funds through the Stock Connect recorded a net purchase of HKD 18.989 billion [1][3] - The total trading volume for the Stock Connect on September 11 was HKD 172.214 billion, with a net purchase of HKD 18.989 billion [1] Stock Performance - In the Shanghai Stock Connect, the total trading volume was HKD 103.737 billion, with a net purchase of HKD 8.073 billion [1] - In the Shenzhen Stock Connect, the total trading volume was HKD 68.477 billion, with a net purchase of HKD 10.916 billion [1] Active Stocks - The most actively traded stock in the Shanghai Stock Connect was Alibaba-W, with a trading volume of HKD 80.75 billion and a net purchase of HKD 29.46 billion, closing up by 0.35% [1][2] - Meituan-W had the highest net sell amount of HKD 9.36 billion, closing down by 5.06% [1][2] - In the Shenzhen Stock Connect, Alibaba-W also led with a trading volume of HKD 43.575 billion and a net purchase of HKD 7.835 billion [2] - The top net purchase stock was Innovent Biologics, with a net purchase of HKD 0.847 billion, despite closing down by 2.51% [2] Summary of Key Stocks | Stock Code | Stock Name | Trading Volume (HKD million) | Net Purchase (HKD million) | Daily Change (%) | |------------|------------------|------------------------------|----------------------------|-------------------| | 09988 | Alibaba-W | 807.48 | 294.62 | 0.35 | | 03690 | Meituan-W | 618.38 | -93.59 | -5.06 | | 00981 | SMIC | 491.04 | 41.75 | 4.97 | | 01801 | Innovent Biologics| 253.79 | 84.73 | -2.51 | | 00700 | Tencent Holdings | 263.33 | -92.26 | -0.63 | [2]

Market Overview - On September 11, the Hang Seng Index fell by 0.43% with a total southbound trading volume of HKD 172.21 billion, including buy transactions of HKD 95.60 billion and sell transactions of HKD 76.61 billion, resulting in a net buy of HKD 18.99 billion [1] Southbound Trading Activity - The southbound trading through Stock Connect (Shenzhen) had a total trading volume of HKD 68.48 billion, with buy transactions of HKD 39.70 billion and sell transactions of HKD 28.78 billion, leading to a net buy of HKD 10.92 billion [1] - The southbound trading through Stock Connect (Shanghai) had a total trading volume of HKD 103.74 billion, with buy transactions of HKD 55.91 billion and sell transactions of HKD 47.83 billion, resulting in a net buy of HKD 8.07 billion [1] Active Stocks - Alibaba-W was the most actively traded stock with a total trading volume of HKD 124.32 billion and a net buy of HKD 37.30 billion, closing with a price increase of 0.35% [1][2] - Other notable stocks included Meituan-W and SMIC, with trading volumes of HKD 84.52 billion and HKD 80.43 billion, respectively [1] - Tencent Holdings had the highest net sell amount of HKD 11.51 billion, closing down by 0.63% [1][2] Continuous Net Buying and Selling - Alibaba-W and SMIC were the only two stocks with continuous net buying for more than three days, with Alibaba-W having a total net buy of HKD 371.43 billion over 15 days and SMIC with HKD 15.76 billion over 3 days [2] - Stocks with continuous net selling included Kangfang Biotech, Tencent Holdings, and Meituan-W, with total net sell amounts of HKD 17.48 billion, HKD 14.61 billion, and HKD 10.28 billion, respectively [2]

智通财经APP讯，康宁杰瑞制药-B(09966)发布公告，该公司与石药集团有限公司(01093)附属公司上海 津曼特生物科技有限公司合作开发的KN026联合化疗用于治疗至少接受过一种系统性治疗(必须包含曲 妥珠单抗联合化疗)失败的人表皮生长因子受体2(HER2)阳性(HER2+)局部晚期、复发或转移性胃/胃 - 食 管结合部腺癌(GC/GEJ)患者的新药上市申请(新药上市申请)，已获中国国家药品监督管理局(国家药监 局)受理。本次新药上市申请主要是基于一项关键II/III期临床试验，其期中分析结果显示，与现有标准 治疗相比，KN026联合化疗显著提高临床疗效，延长患者的无进展生存期(PFS)和总生存期(OS)，且在 安全性方面无新发安全性风险，心脏毒性发生率低，免疫原性低。此外，KN026已于2023年11月4日获 国家药监局药品审评中心授予突破性治疗药物认定，并已于2025年8月28日获优先审评审批资格。 该信息由智通财经网提供 目前，HER2+ 胃癌二线治疗尚无获批上市的抗HER2药物，KN026是中国首个在胃癌二线治疗中获得阳 性结果的抗HER2双特异性抗体药物。KN026的II期临床试验结果于2024 ...

Core Viewpoint - The application for the new drug KN026 (Anituzumab Injection) developed by the company's subsidiary has been accepted by the National Medical Products Administration of China, targeting HER2-positive gastric cancer patients who have failed at least one systemic treatment [1][2]. Group 1 - The product is a bispecific antibody that targets two non-overlapping epitopes of HER2, leading to HER2 signal blockade [2]. - The objective response rate for the product in combination with chemotherapy is reported at 40.0%, with a median progression-free survival of 8.6 months and a median overall survival of 13.2 months based on the results of a Phase II clinical trial [2]. - The application is primarily based on a key Phase II/III clinical trial (KC-WISE), which shows significant clinical efficacy compared to current standard treatments, with no new safety risks identified [2]. Group 2 - Currently, there are no approved anti-HER2 drugs for second-line treatment of HER2-positive gastric cancer, making this product the first bispecific antibody to achieve positive results in this indication in China [2]. - The company is actively advancing multiple clinical trials for the product targeting different solid tumor indications, with gastric and breast cancer developments currently in critical Phase III clinical trial stages [2].

Core Insights - Corning Jereh Pharmaceutical-B (09966) has received acceptance for its new drug application for KN026, a combination chemotherapy treatment for HER2-positive gastric cancer patients who have failed at least one systemic therapy, from the National Medical Products Administration of China [1] - The application is based on a pivotal Phase II/III clinical trial that demonstrated significant clinical efficacy, prolonging progression-free survival (PFS) and overall survival (OS) compared to existing standard treatments, with a low incidence of cardiac toxicity and immunogenicity [1] - KN026 is the first bispecific antibody drug in China to achieve positive results in second-line treatment for HER2-positive gastric cancer, with an objective response rate of 40.0% and a median PFS of 8.6 months reported at the 2024 European Society for Medical Oncology annual meeting [2] Company Developments - The collaboration between Corning Jereh Pharmaceutical and Shanghai Jinmant Biotech, a subsidiary of CSPC Pharmaceutical Group (01093), is focused on the development of KN026 [1] - KN026 has been granted breakthrough therapy designation by the National Medical Products Administration and has received priority review status, indicating its potential significance in treating gastric cancer [1] Industry Context - Currently, there are no approved anti-HER2 drugs for second-line treatment of HER2-positive gastric cancer, highlighting the market opportunity for KN026 [2] - The positive clinical trial results for KN026 may pave the way for its adoption in clinical practice, addressing an unmet medical need in the treatment of gastric cancer [2]