Core Insights - Eli Lilly announced long-term extension results from its TRAILBLAZER-ALZ2 Phase 3 clinical study, showing significant disease progression slowdown in participants treated with donanemab compared to an untreated cohort from the Alzheimer's Disease Neuroimaging Initiative (ADNI) database [1] - The benefits of donanemab treatment continued to enhance over a three-year period, indicating sustained efficacy [1] - Participants who started treatment later still experienced benefits, but those who received early treatment had a significantly lower risk of progressing to the next stage of the disease compared to the delayed treatment group [1] - These findings were presented at the 2025 Alzheimer's Association International Conference (AAIC) held in Toronto [1]

Core Insights - Biogen has raised its financial guidance for 2025, driven by the continued growth in sales of its Alzheimer's drug, Leqembi, which has helped the company exceed Wall Street revenue expectations [1][3] Financial Performance - Biogen expects earnings per share for 2025 to reach $15.50 to $16.00, an increase from the previous forecast of $14.50 to $15.50 [3] - The company anticipates that total revenue for this year will remain flat compared to 2024, revising earlier expectations of a low single-digit percentage decline [3] - In Q2, Biogen reported total revenue of $2.6 billion, surpassing analyst expectations of $2.3 billion [3] Product Performance - Leqembi generated global revenue of $125 million in Q2, exceeding Wall Street expectations [3] - Sales of Leqembi in the previous two quarters were $96 million and $87 million, respectively [3] - The rare disease treatment Skyclarys achieved approximately $130 million in sales, aligning with expectations [3] Strategic Direction - Since taking office at the end of 2022, CEO Chris Viehbacher has focused on transforming Biogen by enhancing Leqembi sales, cutting costs, and reducing reliance on high-risk neurological drugs [3]

Core Viewpoint - 康哲药业's new drug ZUNVEYL has received acceptance for its New Drug Application (NDA) from the National Medical Products Administration (NMPA) in China, aimed at treating mild to moderate Alzheimer's disease symptoms [1] Group 1: Product Details - ZUNVEYL is a new generation acetylcholinesterase inhibitor (AChEI) that improves cognitive and memory functions in Alzheimer's patients by increasing central acetylcholine levels [2] - The drug is a prodrug of galantamine, designed to reduce gastrointestinal side effects and improve patient tolerance, with recorded gastrointestinal adverse events below 2% [2] - ZUNVEYL is the second oral therapy for Alzheimer's approved by the FDA in the last decade, potentially enhancing medication adherence among patients [2] Group 2: Market Context - Alzheimer's disease is a chronic neurodegenerative condition, with Alzheimer's-type dementia accounting for 50% to 70% of all dementia cases, affecting approximately 9.83 million patients in China [3] - The increasing aging population is expected to raise the number of Alzheimer's patients, intensifying the disease burden [3] - Current Alzheimer's medications primarily focus on improving cognitive symptoms, with a significant demand for safer treatment options due to high side effect rates of existing drugs [3] Group 3: Strategic Partnerships - 康哲药业 has signed a licensing and collaboration agreement with Alpha Cognition Inc. for ZUNVEYL, granting exclusive rights for development and commercialization in Asia (excluding Japan and the Middle East), Australia, and New Zealand [4] - The agreement is set for an initial term of twenty years, with automatic five-year extensions unless terminated by either party [4] - ZUNVEYL is expected to diversify 康哲药业's innovative drug portfolio and enhance its competitive strength in the market, potentially benefiting the company's performance upon approval [4]

自願性及業務進展公告 就治療輕度至中度阿爾茨海默型癡呆症狀的 改良型新藥ZUNVEYL中國上市許可申請已獲受理 China Medical System Holdings Limited（「本公司」，連同其附屬公司統稱為「本集團」） 欣然宣佈，改良型新藥ZUNVEYL（擬定通用名：葡萄糖酸苯加蘭他敏腸溶片） （「ZUNVEYL」或「產品」）新藥上市許可申請（NDA）已於二零二五年七月二十八 日獲得中國國家藥品監督管理局（NMPA）受理。產品擬用於治療成人輕度至中度阿爾 茨海默型癡呆症狀。 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，並表明概不就因本公告全部或任何部分內容而產生 或因倚賴該等內容而引致的任何損失承擔任何責任。 本公告乃由本公司自願刊發，旨在向潛在投資者及本公司股東通知本集團最新業務進 展，建議股東和投資者在進行本公司股票及其他證券的交易時謹慎操作。 ZUNVEYL於二零二四年七月獲得美國食品和藥物管理局（FDA）批准上市用於治療成 人輕度至中度阿爾茨海默型癡呆症狀，屬於新一代乙酰膽鹼酯酶抑制劑（AChEI），通 過抑制乙酰膽鹼酯酶 ...

Core Viewpoint - The article discusses a groundbreaking study on tau protein disassembly in Alzheimer's disease, highlighting the potential of D-type peptides as a novel therapeutic strategy to combat neurodegenerative diseases [3][15]. Group 1: Alzheimer's Disease and Tau Protein - Alzheimer's disease (AD) is characterized by cognitive decline and is closely associated with the abnormal aggregation of tau protein and β-amyloid protein [2]. - Tau protein aggregation is more strongly correlated with the cognitive symptoms and severity of Alzheimer's disease compared to β-amyloid [2]. Group 2: Research Findings - A study published in Nature by Dr. Ke Hou from UCLA reveals that D-type peptides can disassemble tau fibrils without the need for enzymatic activity or external energy sources [3][15]. - The research introduces a new paradigm in amyloid protein studies, enhancing understanding of protein aggregation dynamics and inspiring innovative treatment strategies for Alzheimer's and other amyloid-related diseases [3][15]. Group 3: D-type Peptides Advantages - D-type peptides exhibit higher specificity and binding affinity compared to small molecules, with lower immunogenicity and resistance to proteolytic degradation [8]. - Previous studies indicated that D-type peptides could decompose tau protein fibers extracted from Alzheimer's patients and improve behavioral deficits in mouse models [8]. Group 4: Mechanism of Action - The study identified that D-type peptides assemble into amyloid-like fibers, which are essential for disassembling tau protein fibers [12]. - The tension released during the transition from left-handed to right-handed helical structures of these peptides is sufficient to disrupt local hydrogen bonds in tau fibers, leading to their disintegration [13][15]. Group 5: Implications for Treatment - The findings suggest that D-type peptides could revolutionize treatment methods for Alzheimer's disease and provide new tools for tackling other neurodegenerative diseases like Parkinson's and Huntington's disease [15]. - The stability, protease resistance, and good biocompatibility of D-type peptides allow them to cross the blood-brain barrier without eliciting harmful immune responses [15].

Core Viewpoint - The National Health Commission of China has banned the use of "Lymphatic-Venous Anastomosis (LVA)" for the treatment of Alzheimer's disease due to a lack of long-term, statistically significant safety and efficacy data [1][2][15]. Group 1: Background of LVA Surgery - LVA surgery is not a new procedure; it was originally developed in the late 20th century for treating lymphatic diseases like lymphedema [2][12]. - The application of LVA for Alzheimer's treatment began in 2018 by Dr. Xie Qingping, leading to its widespread adoption in various medical institutions [2][12]. - Prior to the ban, over a hundred hospitals had been performing LVA surgeries, with total cases exceeding a thousand [7][12]. Group 2: Financial Aspects and Demand - The cost of LVA surgery ranges from tens of thousands to over 210,000 yuan, with many hospitals charging between 20,000 to 50,000 yuan [12][9]. - The financial burden of long-term care for Alzheimer's patients often makes LVA surgery an attractive option for families, as it can be more cost-effective compared to ongoing care [12][9]. - Hospitals have been motivated to promote LVA surgery due to the potential for significant revenue generation, especially in light of financial struggles faced by many medical institutions [12][13]. Group 3: Regulatory and Clinical Concerns - The rapid promotion of LVA surgery occurred in a regulatory vacuum, with many institutions conducting the procedure without sufficient clinical trial data to support its safety and efficacy [14][15]. - The National Health Commission's ban highlights the need for rigorous clinical trials and ethical guidelines for new treatments, as many hospitals had been charging for a procedure that lacked proper validation [15][16]. - There are currently only 12 registered clinical trials for LVA surgery in Alzheimer's treatment, indicating a significant gap in clinical research [15][16].

Core Viewpoint - The National Health Commission of China has suspended the use of "Cervical Deep Lymphatic-Venous Anastomosis (LVA)" for Alzheimer's disease treatment due to concerns over its safety, efficacy, and lack of high-quality evidence supporting its clinical application [1][9][10] Group 1: Treatment Overview - Alzheimer's disease is a progressive neurodegenerative condition characterized by cognitive impairment and emotional disturbances, leading to significant declines in daily functioning [2] - Traditional treatments primarily involve medication, but drug development for Alzheimer's has been slow, with only a few new drugs approved in the last two decades [2][3] - LVA surgery aims to connect lymphatic vessels to nearby veins to facilitate the drainage of harmful proteins from the brain, potentially improving cognitive function [3][8] Group 2: Clinical Application and Controversy - The LVA procedure has been performed in over 130 hospitals across 28 provinces in China, with more than 200 Alzheimer's patients treated at one hospital alone [3][4] - Despite its growing popularity, the LVA treatment remains controversial and is considered to be in the early exploratory stage of clinical research [4][9] - Patient feedback on the effectiveness of the LVA surgery is polarized, with some reporting improvements while others see no significant benefits [5][6][7] Group 3: Regulatory Response - The National Health Commission's decision to halt the procedure reflects a commitment to patient safety and the need for rigorous evidence before clinical application [1][10] - The Commission has mandated local health authorities to investigate the use of LVA and ensure that medical institutions cease its application until further evidence is available [9][10] - Future clinical research on LVA will be guided by the availability of sufficient preclinical evidence and ethical review [9][10]

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].