Core Viewpoint - The Trump administration is drafting an executive order that will impose three major restrictions on commercial transactions involving Chinese innovative drug patents or rights, focusing on national security reviews by the Committee on Foreign Investment in the United States (CFIUS) [1][2]. Summary by Sections Executive Order Details - The draft includes three main provisions: 1. Inclusion of Chinese innovative drug BD transactions in the CFIUS mandatory review list, ending the previous "low-risk automatic exemption" practice [2]. 2. FDA will implement "racial sensitivity supplementary reviews" for drugs relying on Chinese clinical data, requiring at least 20% comparative data from non-Asian populations [2]. 3. Establishment of a "key drug domestic production fund" to provide production subsidies for 15 categories of drugs, including antibiotics and acetaminophen, while implementing a "domestic priority" principle in federal procurement [2]. Market Reaction - The market reacted swiftly to the policy risks, with the Hong Kong innovative drug index (HK1105) dropping 3.82% on September 11, 2025, and the A-share innovative drug sector (BK1106) declining 2.17%, with over 80% of stocks in the sector experiencing pullbacks [3]. - The following day, the indices showed signs of recovery, indicating investors' responses to policy uncertainties and rational corrections [3]. Globalization Trends - Despite the geopolitical risks, the trend of Chinese innovative drugs going global remains intact, with total license-out transactions to Europe and the U.S. reaching $9.43 billion as of September 2025 [3]. - Major transactions include a $950 million licensing deal between BeiGene and Royalty Pharma, and a $6 billion global licensing agreement between 3SBio and Pfizer, highlighting a shift towards milestone payments and regional licensing [3]. Industry Challenges - The domestic market faces challenges, with annual growth in medical insurance fund spending (approximately 12%) lagging behind the growth in innovative drug R&D investment (approximately 25%) [4]. - The average reduction in medical negotiations remains high at 54%, and commercial health insurance coverage for innovative drugs is below 15%, creating a supply-demand imbalance that necessitates going global [4]. Risk Resilience Assessment - Goldman Sachs has categorized Chinese innovative drug companies into three risk resilience tiers based on their sensitivity to policy changes and operational capabilities [4][5]. - Companies with mature global layouts exhibit the strongest resilience, while those heavily reliant on domestic markets show the weakest resilience [5][10]. Strategic Defense Framework - A three-dimensional defense system is proposed to address risks associated with the executive order, focusing on transaction review, data compliance, and supply chain security [13]. - Strategies include conducting national security risk pre-assessments for transactions over $50 million and establishing partnerships with U.S. law firms to navigate regulatory challenges [14][15]. Conclusion - The construction of a quantifiable "risk resilience index" is essential for Chinese innovative drugs in the global 2.0 era, emphasizing the need for companies to embed policy hedging clauses in transaction structures and consider racial diversity data in clinical stages [23].

Core Viewpoint - The approval of ALMB-0166 for Phase II clinical trials in China represents a significant advancement in the treatment of Parkinson's disease, addressing a critical need for new therapies in this area [1][2]. Group 1: Company Developments - The company has received approval from the National Medical Products Administration of China to conduct Phase II clinical trials for ALMB-0166, a first-in-class humanized monoclonal antibody inhibitor targeting the novel target Connexin43 (Cx43) [1]. - ALMB-0166 is developed by the company's subsidiary, AlaMab Therapeutics Inc., and is intended for treating neurological diseases such as Parkinson's disease, acute ischemic stroke, and acute spinal cord injury [1]. Group 2: Industry Context - Parkinson's disease is the second most common neurodegenerative disease globally, characterized by the progressive degeneration of dopaminergic neurons in the substantia nigra and the formation of Lewy bodies [2]. - Current treatments, primarily based on levodopa, only alleviate symptoms without reversing disease progression or achieving a cure, highlighting the urgent need for new therapeutic options [2]. - ALMB-0166 targets Cx43 hemichannels to inhibit the release and spread of neuroinflammatory factors, thereby maximizing neuroprotection [2]. - Preclinical studies in subacute and chronic Parkinson's disease animal models have shown that ALMB-0166 significantly inhibits the reduction of dopamine levels in the brain and restores behavioral and functional abilities, demonstrating a favorable dose-response relationship [2]. Group 3: Future Plans - The company is committed to advancing the clinical research of ALMB-0166 across various indications, aiming for its expedited market launch [3].

Core Viewpoint - The company has received approval from the National Medical Products Administration of China to conduct Phase II clinical trials for ALMB-0166, a first-in-class humanized monoclonal antibody inhibitor targeting the novel target Connexin43 (Cx43), aimed at treating Parkinson's disease [1][2]. Group 1: Product Development - ALMB-0166 is developed by the company's subsidiary, AlaMab Therapeutics Inc., and is intended for treating neurological diseases such as Parkinson's disease, acute ischemic stroke, and acute spinal cord injury [1]. - The company is committed to advancing clinical research for ALMB-0166 across various indications, aiming for its swift market launch [3]. Group 2: Parkinson's Disease Context - Parkinson's disease is the second most common neurodegenerative disease globally, characterized by the progressive degeneration of dopamine neurons in the substantia nigra and the formation of Lewy bodies [2]. - Current treatments, primarily centered around levodopa, only alleviate symptoms without reversing disease progression or achieving a cure, highlighting the urgent need for new therapeutic options [2]. - ALMB-0166 targets Cx43 hemichannels to inhibit the release and spread of neuroinflammatory factors, thereby maximizing neuroprotection [2]. - Preclinical studies in subacute and chronic Parkinson's disease animal models have shown that ALMB-0166 significantly inhibits the reduction of dopamine levels in the brain and restores behavioral and functional capabilities, demonstrating a favorable dose/effect relationship [2].

Core Viewpoint - The approval of ALMB-0166 for Phase II clinical trials in China represents a significant advancement in the treatment of Parkinson's disease, addressing a critical need for new therapies in this area [1][2]. Group 1: Company Developments - The company, Shiyao Group, has announced that its developed drug ALMB-0166 has received approval from the National Medical Products Administration of China to conduct Phase II clinical trials for evaluating its efficacy in patients with Parkinson's disease [1]. - ALMB-0166 is a first-in-class humanized monoclonal antibody inhibitor targeting the novel target Connexin 43 (Cx43), developed by the company's subsidiary, AlaMab Therapeutics Inc. [1]. - The company is committed to advancing the clinical research of ALMB-0166 across various indications, aiming for its swift market launch [3]. Group 2: Industry Context - Parkinson's disease is the second most common neurodegenerative disease globally, characterized by the progressive degeneration of dopamine neurons in the substantia nigra and the formation of Lewy bodies [2]. - Current treatments, primarily based on levodopa, only alleviate symptoms without reversing disease progression or achieving a cure, highlighting the urgent need for new therapeutic options [2]. - ALMB-0166 targets Cx43 hemichannels to inhibit the release and spread of neuroinflammatory factors, maximizing neuroprotection, and preclinical studies have shown significant efficacy in preserving dopamine levels and restoring behavioral functions in animal models [2].

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。 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 主席 ALMB -0166為一款同類首創（ First-in-class ）針對全新靶點半通道膜蛋白Connexin 43 (Cx43)的 人源化單克隆抗體抑制劑，由本公司附屬公司AlaMab Therapeutics Inc.自主研發，用於治療 帕金森氏症、急性缺血性腦卒中、急性脊髓損傷等神經系統疾病。 帕金森氏症是全球第二大神經退行性疾病，以黑質多巴胺神經元進行性退變和路易小體形 成為主要病理特徵。帕金森氏症的病因迄今尚未完全明確，臨床表現以靜止性震顫、肌強 直、動作遲緩、姿勢平衡障礙的運動症狀和睡眠障礙、認知和精神障礙等非運動症狀為顯 著特徵。其運動和非運動症狀會隨疾病進展逐漸加重，嚴重影響患者的生活質量，並給家 庭和社會帶來沉重的經濟與 ...

每经AI快讯，石药集团(01093.HK)涨超3%，截至发稿，涨2.32%，报10.58港元，成交额5.26亿港元。 （文章来源：每日经济新闻） ...

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]