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].

Core Insights - BrightGene Pharmaceutical Co., Ltd. presented promising Phase II clinical trial data for its dual-target agonist BGM0504 at the 85th American Diabetes Association (ADA) Scientific Sessions, indicating potential advantages over Semaglutide in treating type 2 diabetes and obesity [1][4] - The company also shared preclinical results for a new Amylin, BGM1812, which shows enhanced receptor activation and potential for effective weight management [1][5] Group 1: BGM0504 Clinical Data - BGM0504 demonstrated significant reductions in HbA1c, fasting blood glucose, postprandial blood glucose, weight, and blood pressure in adult patients with type 2 diabetes during Phase II trials [3][4] - The majority of adverse events were mild to moderate and resolved without intervention, with no observed cases of hypoglycemia or unexpected adverse events, indicating a favorable risk-benefit profile [3][4] - The drug is currently undergoing Phase III clinical trials in China for weight management and type 2 diabetes, with over 1,000 patients treated, showing excellent efficacy and safety [4] Group 2: BGM1812 Development - BGM1812 is a novel Amylin designed using AI/ML optimization, characterized by strong and prolonged effects, with potential for development into a weekly oral formulation [5] - The company aims to leverage its expertise in peptide development to accelerate innovative therapies for unmet clinical needs in metabolic diseases [4]

Core Insights - Eli Lilly plans to submit a marketing application for efsitora, an insulin treatment for adult patients with type 2 diabetes (T2DM), to global regulatory authorities by the end of this year [1] Group 1: Clinical Trial Results - The company announced detailed results from three Phase 3 clinical studies: QWINT-1, QWINT-3, and QWINT-4 [1] - These studies evaluated the efficacy and safety of efsitora alfa administered once weekly compared to daily basal insulin in T2DM adult patients [1] - All studies achieved their primary endpoints, demonstrating that weekly efsitora is non-inferior to daily basal insulin in reducing hemoglobin A1C levels [1]

整理 | GLP1减重宝典内容团队 在2022年国际糖尿病联盟（IDF）大会上，首次以墙报形式展示了PIONEER 11和PIONEER 12研究的结果。这两项研究以中国人群为 主，为司美格鲁肽片（商品名：诺和忻）在中国的获批提供了重要支持。该药物的治疗剂量为7mg或14mg，适用于在饮食和运动控制 不足的基础上，作为单药或与二甲双胍和/或磺脲类药物联合治疗的成人2型糖尿病（T2DM）患者。 与欧美人群不同，中国的2型糖尿病患者通常在较年轻时就被诊断，且BMI较低，这可能影响药物的治疗效果，因此中国研究是必要 的。 在中国人群中，司美格鲁肽片的疗效和安全性数据相对较少，PIONEER 11和12研究则为该领域提供了重要的临床数据。 PIONEER系列的全球3期临床试验比较了司美格鲁肽片与活性对照药物及安慰剂在降糖效果和安全性上的差异，以及体重的减轻，结果 显示，司美格鲁肽片能够持续改善血糖控制以及减重，且效果优于活性对照药物和安慰剂。 ▍PIONEER 11 单药治疗 PIONEER 11研究在饮食和运动控制不佳的中国2型糖尿病患者中，评估了司美格鲁肽片单药治疗的有效性与安全性。研究结果显示， 中国 人群的临 ...

Core Viewpoint - A new meta-analysis indicates that GLP-1 receptor agonists, used for treating type 2 diabetes and aiding weight loss, may significantly reduce the risk of developing any form of dementia [2][4]. Group 1: Study Overview - The study, led by Catriona Reddin from Galway University, reviewed 26 randomized clinical trials involving over 160,000 participants, providing further evidence of the cognitive improvement potential of GLP-1 drugs [2][4]. - Participants in the trials were type 2 diabetes patients who had not been diagnosed with dementia or cognitive impairment, and they were followed for at least six months [4]. Group 2: Findings and Comparisons - The results showed that the incidence of dementia or cognitive decline was significantly lower in the group using GLP-1 drugs compared to the placebo group [4]. - Previous observational studies suggested a slight reduction in dementia risk associated with GLP-1 drugs, but this meta-analysis provides stronger evidence through controlled clinical trials [2][4]. Group 3: Mechanisms and Implications - The protective effects of GLP-1 drugs may not solely be due to blood sugar control, as SGLT2 inhibitors did not show a significant correlation with dementia risk [7]. - GLP-1 drugs have been found to possess anti-inflammatory properties, which may help mitigate chronic neuroinflammation, a significant factor in dementia [11][12]. - These drugs may also positively impact cardiovascular health, potentially reducing dementia risk related to vascular issues [12]. Group 4: Future Research and Recommendations - While the findings are promising, experts caution against prescribing GLP-1 drugs solely for dementia prevention without further large-scale studies specifically targeting dementia [15]. - Ongoing clinical trials are investigating the use of semaglutide for early Alzheimer's treatment, with results expected later this year [16].

Core Viewpoint - Junsheng Tai Pharmaceutical-B (02511) has announced that its self-developed intestinal and hepatic anti-inflammatory and metabolic regulator, HTD1801, has achieved primary efficacy endpoints and multiple secondary efficacy endpoints in two Phase 3 clinical trials for Type 2 Diabetes Mellitus (T2DM) patients [1][2]. Group 1: Clinical Trial Results - The SYMPHONY 1 and SYMPHONY 2 trials are multi-center, randomized, double-blind, placebo-controlled Phase 3 studies aimed at evaluating the efficacy and safety of HTD1801 in T2DM patients with poor blood glucose control after dietary and exercise interventions (SYMPHONY 1; N=407) and those with inadequate control on metformin (SYMPHONY 2; N=549) [2]. - The primary efficacy endpoint for both studies was the change in glycated hemoglobin (HbA1c) from baseline after 24 weeks of treatment compared to placebo, with secondary endpoints including the percentage of subjects achieving HbA1c <7.0%, fasting plasma glucose (FPG), low-density lipoprotein cholesterol (LDL-C), gamma-glutamyl transferase (GGT), and high-sensitivity C-reactive protein (hs-CRP) [2]. Group 2: Efficacy and Safety Profile - After 24 weeks of treatment, the proportion of patients achieving HbA1c <7.0% in the HTD1801 group was significantly higher than in the placebo group, with HTD1801 also showing significant reductions in both postprandial and fasting blood glucose levels [3]. - HTD1801 demonstrated the ability to lower both glucose and lipids, significantly reducing LDL-C and non-HDL-C levels, as well as inflammatory markers GGT and hs-CRP, which are closely related to cardiovascular events and clinical outcomes in T2DM patients [3]. - Both studies indicated that HTD1801 exhibited good safety and tolerability, with the most common adverse events being gastrointestinal in nature, consistent with previous clinical findings, and less than 2% of subjects discontinued due to adverse events, with no significant risk of hypoglycemia observed [3].