石药集团(01093)涨超3%，截至发稿，涨2.32%，报10.58港元，成交额5.26亿港元。 该产品为集团自主研发的化学1类新药，是一款作用于呼吸道合胞病毒(RSV)的新型口服小分子候选药 物。本次获批的适应症为用于治疗由RSV引起的呼吸道感染(该疾病)。临床前研究表明，该产品具备良 好的口服生物利用度等药代动力学性质，并在疾病动物模型中能显著降低RSV病毒滴度，且安全性较 高。 目前，国内外尚无靶向RSV的小分子药物上市。该产品有望成为针对该疾病的有效治疗药物，具有较高 的临床开发价值。 消息面上，9月12日，石药集团发布公告，集团开发的SYH2066片(该产品)已于2025年9月获中华人民共 和国国家药品监督管理局批准，可在中国开展临床试验。 ...

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 ...