Core Viewpoint - The National Health Commission of China has issued two important notifications prohibiting the use of specific surgical techniques for treating Alzheimer's disease and type 2 diabetes due to safety and efficacy concerns [2][4][5]. Group 1: Prohibition of Surgical Techniques - The "cervical deep lymphatic vessel/lymph node-venous anastomosis" technique is prohibited for Alzheimer's treatment as it is still in the early exploratory stage of clinical research, lacking clear indications and contraindications, and high-quality evidence for safety and efficacy [4]. - The "jejunum-ileum anastomosis" technique is banned for type 2 diabetes treatment due to uncertain safety and efficacy, with potential severe complications such as liver failure and malnutrition [5]. Group 2: Regulatory Actions - Local health administrative departments are required to ensure that medical institutions cease the use of the prohibited techniques for the specified conditions and provide follow-up services for affected patients [4][5]. - The National Health Commission will guide qualified medical institutions to strengthen clinical research design once sufficient preclinical research evidence is available, and will reassess the clinical application of these techniques based on research outcomes [4].

Core Viewpoint - The National Health Commission has issued notifications prohibiting the use of "jejunum-ileum anastomosis" for the treatment of type 2 diabetes and "cervical deep lymphatic vessel/lymph node-venous anastomosis" for Alzheimer's disease, citing lack of safety and efficacy evidence [2][6]. Group 1: Jejunum-Ileum Anastomosis - Jejunum-ileum anastomosis is a surgical procedure that connects the jejunum and ileum, primarily used for bowel obstruction, tumor resection reconstruction, or congenital malformation repair [3]. - The assessment concluded that the safety and efficacy of jejunum-ileum anastomosis for diabetes treatment are uncertain, with potential severe complications such as liver failure and malnutrition [4]. - Local health authorities are required to ensure that medical institutions cease the use of this technique for diabetes treatment and enhance regulatory oversight [5]. Group 2: Cervical Deep Lymphatic Vessel/Venous Anastomosis - Cervical deep lymphatic vessel/lymph node-venous anastomosis is a microsurgical technique that connects lymphatic vessels or nodes to nearby veins, mainly used for treating persistent lymphedema [7]. - The evaluation indicated that this technique is still in the early exploratory stage of clinical research, lacking direct evidence for safety, efficacy, and economic viability [8]. - Provincial health authorities must oversee the cessation of this technique's application for Alzheimer's treatment and guide qualified medical institutions in conducting clinical research in a scientific and regulated manner [9].

Core Viewpoints - The National Health Commission has issued notifications prohibiting the use of "jejunum-ileum anastomosis" for treating type 2 diabetes and "cervical deep lymphatic vessel/vein anastomosis" for treating Alzheimer's disease due to lack of sufficient evidence supporting their safety and efficacy [1][2]. Group 1: Jejunum-Ileum Anastomosis for Type 2 Diabetes - The National Health Commission assessed the use of "jejunum-ileum anastomosis" for type 2 diabetes and found it lacks theoretical support and high-quality evidence, leading to its prohibition [1]. - Local health authorities are required to ensure that medical institutions cease using this technique for diabetes treatment, with serious consequences for non-compliance [1]. Group 2: Cervical Deep Lymphatic Vessel/Vein Anastomosis for Alzheimer's Disease - The National Health Commission has identified that "cervical deep lymphatic vessel/vein anastomosis" is still in the early exploratory stage of clinical research, with unclear indications and contraindications, resulting in its prohibition for Alzheimer's treatment [2][3]. - Local health authorities must monitor and ensure that medical institutions stop using this technique, while also providing follow-up services for affected patients [3]. - The National Health Commission will consider re-evaluating the clinical application of this technique once sufficient preclinical research evidence is available [3].

Core Viewpoint - The National Health Commission of China has prohibited the use of "cervical deep lymphatic vessel/lymph node-venous anastomosis" for the treatment of Alzheimer's disease due to insufficient clinical evidence supporting its safety and efficacy [1][4]. Group 1: Regulatory Actions - The National Health Commission organized an expert evaluation of the technique, concluding that it is still in the early exploratory stage of clinical research, with unclear indications and contraindications [1][4]. - Local health authorities are required to ensure that medical institutions cease the use of this technique for Alzheimer's treatment and provide follow-up services for affected patients [1][5]. - Institutions and personnel continuing to use this technique post-notification will face serious consequences under relevant health laws and regulations [2]. Group 2: Technical Overview - "Cervical deep lymphatic vessel/lymph node-venous anastomosis" is a microsurgical technique that connects lymphatic vessels or nodes to nearby veins, primarily used for treating persistent lymphedema [3]. Group 3: Evaluation Findings - The evaluation found a lack of direct evidence from preclinical studies regarding the safety, efficacy, and economic viability of the technique for Alzheimer's treatment [4]. - The technique's application for Alzheimer's disease lacks high-quality evidence from clinical studies and health economics [4]. Group 4: Implementation Guidelines - Provincial health authorities must fulfill their responsibilities in managing the clinical application of medical technologies and enhance daily supervision of medical institutions [5]. - Local health departments should conduct investigations into the clinical application of the technique and ensure compliance with the prohibition [5].

Core Viewpoint - The National Health Commission has issued two important notifications prohibiting specific surgical techniques for the treatment of Alzheimer's disease and type 2 diabetes, emphasizing the need for clinical application management and evidence-based support for medical practices [1]. Group 1: Alzheimer's Disease Treatment - The notification prohibits the use of "cervical deep lymphatic vessel/lymph node-venous anastomosis" for treating Alzheimer's disease due to its early exploratory stage in clinical research [1]. - Expert evaluations indicate that the indications and contraindications for this technique are not clearly defined, and there is a lack of high-quality evidence supporting its safety and effectiveness [1]. Group 2: Type 2 Diabetes Treatment - The notification also bans the use of "jejunum-ileum anastomosis" for the treatment of type 2 diabetes, reflecting similar concerns regarding the clinical application of this surgical method [1]. - The decision underscores the importance of rigorous evaluation and evidence before adopting new medical technologies in clinical settings [1].

国家卫生健康委办公厅日前发布关于禁止将"颈深淋巴管/结—静脉吻合术"应用于阿尔茨海默病治疗的 通知。通知提出，国家卫生健康委近期获悉有个别医疗机构开展"颈深淋巴管/结—静脉吻合术"治疗阿 尔茨海默病，为进一步加强医疗技术临床应用管理，国家卫生健康委组织专家对该技术进行评估，评估 认为该技术处于临床研究早期探索阶段，适应证及禁忌证尚不明确，安全性、有效性缺乏高质量循证医 学证据支撑。根据《医疗技术临床应用管理办法》(国家卫生健康委员会令第1号)有关规定，决定禁止 将"颈深淋巴管/结—静脉吻合术"应用于阿尔茨海默病治疗。 ...

Core Viewpoint - Tencent's cognitive training software "Tencent Brain Exercise" has received medical device registration approval from the Guangdong Provincial Drug Administration, marking its entry into clinical application for improving cognitive abilities in patients with mild cognitive impairment (MCI) [1][3] Industry Overview - The cognitive digital therapy market in China has over 40 companies focusing on this area, with 47 cognitive digital therapy software products approved by the National Medical Products Administration as of October 2024 [2] - The market for cognitive impairment digital therapy is expected to grow significantly, with a projected market size of 2.686 billion yuan in 2023, increasing to 10.467 billion yuan by 2025 and 89.274 billion yuan by 2030, reflecting compound annual growth rates of 97.4% and 53.5% respectively [4] - The number of MCI patients in China is approximately 38.77 million, with a prevalence rate of 15.5%, indicating a substantial patient base driving demand for cognitive digital therapies [4] Company Insights - Tencent's "Tencent Brain Exercise" transforms traditional cognitive rehabilitation into a mobile application format, utilizing gamified cognitive training based on evidence-based medicine principles [3] - The company aims to address the challenges of commercializing digital therapies, as the current business models are still in the early stages of development [1][2] - Brain Dynamics, a competitor in the market, has achieved a market share of 25.0% in the cognitive digital therapy market and 91.6% in the medical-grade cognitive digital therapy market in China, but faces challenges in profitability despite significant revenue growth [5] Challenges in the Market - The cognitive digital therapy sector is experiencing high market education costs and is still in the exploratory phase regarding application scenarios [1][2] - Regulatory challenges exist, as clinical experts have varying opinions on the clinical use of digital therapy products, which complicates their appropriate application [4][5] - The industry faces difficulties in ensuring that payers (such as insurance companies and hospitals) are willing to cover these therapies, which is crucial for sustainable business models [1][2] Competitive Landscape - Major tech companies like Tencent, Alibaba, and ByteDance are entering the healthcare sector, but a mature commercialization model is still needed [6] - The cognitive digital therapy market is characterized by a mix of substantial patient demand and ongoing challenges in commercialization pathways, creating a complex development landscape [2][4]

撰文丨王聪 编辑丨王多鱼 排版丨水成文 晚发性阿尔茨海默病 （Late-Onset Alzheimer's Disease, LOAD） 是指 65 岁之后发病的阿尔茨海默病 （AD） ，占所有阿尔茨海默病的 90% 以上。全基因组关联研究 （GWAS） 已确定了多个 与 LOAD 发病 风险增加相关的基因多态性，许多与 LOAD 风险相关的等位基因通过影响 小胶质细胞 （microglia，MG） 的先天免疫反应和脂质代谢来改变疾病的发生机制。 2025 年 6 月 9 日，西达赛奈医疗中心的研究人员在 Nature 子刊 Nature Aging 上发表了题为： Boosting angiotensin-converting enzyme (ACE) in microglia protects against Alzheimer's disease in 5xFAD mice 的研究论文。 该研究显示，在小胶质细胞中增强 ACE 表达，能够保护阿尔茨海默病小鼠模型的大脑，表明了 表达 ACE 的小胶质细胞可能作为一种治疗阿尔茨海默病的新型细胞疗法。 血管紧张素转换酶 （ACE） 是一种在 全基因组关联研究 ...

Core Viewpoint - The production of Manzoutan capsules, used for treating Alzheimer's disease, has been halted due to the expiration of its drug registration certificate, with the company awaiting approval from the drug regulatory authority [1][8]. Company Summary - Green Valley Pharmaceutical Technology has confirmed the closure of its office and production areas related to Manzoutan capsules, citing the expiration of the drug registration certificate and the ongoing wait for regulatory approval [1][8]. - The company previously acknowledged the difficulties patients faced in obtaining the medication and expressed regret over the potential impact of drug interruptions on patients' conditions [8]. Market Summary - The market price of Manzoutan capsules has surged approximately 40% in recent months, with prices on e-commerce platforms ranging from 428 yuan to 534.5 yuan per box, and some pharmacies listing prices as high as 5000 yuan per box [4]. - Reports indicate that many patients are struggling to find the medication, with numerous complaints about stock shortages and price hikes on social media [5][4]. Regulatory Summary - The approval status of Manzoutan capsules is currently pending, having entered the review queue on October 25, 2024. The situation of halting production due to expired licenses is considered rare in the industry [8][9]. - Manzoutan capsules were conditionally approved for market entry in China in November 2019, marking it as the first new drug for Alzheimer's disease approved globally since 2003 [8][9]. Clinical Summary - Concerns regarding the efficacy and safety of Manzoutan capsules persist, as the drug was approved under conditions requiring further research on its pharmacological mechanisms and long-term safety [9]. - The three-phase clinical trial for Manzoutan lasted only 36 weeks, which is deemed insufficient for a chronic degenerative disease like Alzheimer's, typically requiring longer observation periods to confirm sustained cognitive improvement [9].

Core Viewpoint - The company, Green Valley Pharmaceutical Technology, has announced the suspension of production for the mannitol sodium capsule product line due to the expiration of its drug registration certificate, currently awaiting approval from the drug regulatory authority [1] Group 1: Company Actions and Responses - Green Valley Pharmaceutical Technology has halted the production of mannitol sodium capsules and will close related office and production areas [1] - Employees affected by the suspension will receive wages at the minimum wage standard set by Shanghai, with social security and housing funds being paid normally [1] - The company has committed to restoring original salary standards once its operational conditions improve and it regains the ability to pay [1] Group 2: Product Background and Market Impact - Mannitol sodium capsules, developed in collaboration with Ocean University of China and the Shanghai Institute of Materia Medica, are used for mild to moderate Alzheimer's disease to improve cognitive function [1] - Since its launch in November 2019, the drug has benefited over 500,000 patients, with projected sales exceeding 2.1 million boxes in 2024 [1] - There is currently a shortage of mannitol sodium across the country, with prices on online platforms fluctuating daily [1] - The company has received over 9,300 requests from Alzheimer's patients for purchasing the drug through its hotline and online platforms [1] Group 3: Clinical Research and Development - The mechanism of action of mannitol sodium was published in a cover article in "Cell Research" in 2019, and further validation studies were published in 2024 [2] - An international Phase III clinical trial was initiated in 2020 but was abruptly halted in May 2022 due to increased dropout rates and funding issues [2] - Domestic post-marketing clinical research has involved 3,300 patients, with mid-term analysis showing 16% of patients exhibiting stable or improved efficacy indicators [3] - The final results of the post-marketing study are expected to be presented at an international academic conference in the second half of 2025 [3] Group 4: Industry Context - Alzheimer's disease remains a significant challenge in the medical field, with few new drugs approved since 2003, primarily focusing on symptom improvement [3] - Major pharmaceutical companies, including Eli Lilly, Takeda, Merck, Pfizer, and Roche, have entered the market, but no groundbreaking drugs have emerged yet [3] - The strategy for treating Alzheimer's is diversifying, with a growing number of clinical trials focusing on neuroinflammation rather than solely relying on amyloid-beta [3]