Core Viewpoint - The approval of XinErMei® (a dual receptor agonist for glucagon and GLP-1) by the National Medical Products Administration (NMPA) marks a significant advancement in obesity treatment, aiming to address the urgent issue of overweight and obesity in China [2][5][6]. Group 1: Product Overview - XinErMei® is the world's first GCG/GLP-1 dual receptor agonist for weight management, which not only suppresses appetite but also promotes fat burning and reduces visceral fat [5][11]. - Clinical studies indicate that patients using XinErMei® can achieve a weight loss of up to 21%, with liver fat content reduced by over 80%, waist circumference decreased by 11 cm, and neck circumference by 3 cm [5][12]. Group 2: Market Context - China faces a severe obesity crisis, with approximately 500 million adults classified as overweight or obese, the highest globally [8][9]. - The World Obesity Federation estimated that the economic loss due to overweight and obesity in China could reach $283.3 billion in 2020 [8]. Group 3: Clinical Evidence - The approval of XinErMei® is based on the results of the GLORY-1 Phase III clinical trial, which demonstrated significant weight loss compared to placebo, with mean percentage changes from baseline at week 48 being -12.0% and -14.8% for the 4 mg and 6 mg doses, respectively [11][12]. - The trial also showed that 73.5% and 82.8% of participants in the 4 mg and 6 mg groups, respectively, achieved a weight loss of at least 5% from baseline [11]. Group 4: Regulatory and Clinical Guidelines - The National Health Commission has included "weight management" in the "Healthy China 2030" initiative, emphasizing the need for effective weight management strategies [6][9]. - Recent clinical guidelines recommend the early initiation of pharmacological treatment for patients who do not achieve weight loss goals through lifestyle interventions alone [9][10]. Group 5: Future Implications - XinErMei® is expected to reshape the clinical treatment landscape for obesity in China, providing a new therapeutic option that addresses both weight loss and metabolic health [6][14]. - The innovative delivery system of XinErMei® enhances convenience and safety, making it a promising choice for patients [14].

整理 | GLP1减重宝典内容团队 6 月 24 日，信达生物宣布，其 GCG/GLP-1 双受体激动剂玛仕度肽（研发代号 IBI362）在中国 2 型糖尿病患者中的 III 期临床研究 （DREAMS-1）主要结果已在 2025 年美国糖尿病协会（ADA）科学年会以口头报告形式（306-OR）正式发布。信达生物制药集团钱镭博士作 为报告人，对研究核心数据进行了汇报。相关详细研究结果将随后发表于权威学术期刊。 玛仕度肽在降糖方面表现出显著疗效。24 周时，玛仕度肽 4 mg 和 6 mg 组 HbA1c 分别下降 1.57% 和 2.15%，显著优于安慰剂组的 0.14%。 在达标率方面，玛仕度肽组 HbA1c <7.0% 的比例分别为 68.6% 和 87.4%，而安慰剂组仅为 10.7%；HbA1c ≤6.5% 的达标率分别为 55.6% 和 81.5%，安慰剂组仅为 4.4%。 减重方面，玛仕度肽同样展现出明确优势。24 周时，4 mg 和 6 mg 组体重较基线下降幅度分别为 5.61% 和 7.81%，显著高于安慰剂组的 1.26%。体重下降 ≥5% 的患者占比分别为 50.9% 和 69.0%，而 ...

Core Insights - The development of new drugs for obesity treatment in China is gaining momentum, with the recent publication of the phase III clinical study results for the drug Masitide in a top medical journal, indicating a significant advancement in the country's drug development capabilities [1][3] - Masitide is the world's first and only GCG/GLP-1 dual receptor agonist approved for weight loss and glycemic control, highlighting its potential in addressing complex metabolic issues associated with obesity [1][2] Group 1: Drug Development and Clinical Research - The phase III clinical study (GLORY-1) of Masitide has been recognized as a milestone, showcasing China's ability to conduct clinical research at an international level [3] - The dual mechanism of action of Masitide, which combines appetite suppression and metabolic acceleration, is expected to provide a more comprehensive solution for obesity management compared to single-target therapies [1][3] Group 2: Challenges in Drug Development Ecosystem - There is a notable gap in the drug development ecosystem in China compared to international standards, particularly in the transition from basic research to clinical application [3] - The majority of new drug patents in the U.S. are held by companies, while in China, 70-80% are held by research institutions, indicating a need for better integration of research and industry [3] Group 3: Financial and Policy Support - The high failure rate of innovative drug development poses a significant challenge, as the costs of unsuccessful products are absorbed by successful ones, necessitating a robust financial return for companies [4] - The Chinese government is implementing a comprehensive support plan for innovative drug development, focusing on policy coordination across pricing, insurance, and investment to foster a conducive environment for drug innovation [4]

Core Viewpoint - The article highlights the successful Phase III clinical trial results of the obesity treatment drug Masitide (GCG/GLP-1 dual receptor agonist), which has been published in the prestigious New England Journal of Medicine (NEJM), marking a significant milestone for China's innovation in the field of endocrine metabolism and potentially transforming obesity treatment globally [1][5][10]. Group 1: Clinical Research and Results - The GLORY-1 study, which included 610 participants, demonstrated that Masitide significantly reduced body weight compared to placebo, with 73.9% and 82.0% of participants in the 4 mg and 6 mg groups, respectively, achieving a weight loss of ≥5% by week 32 [9]. - By week 48, 35.7% and 49.5% of participants in the 4 mg and 6 mg groups, respectively, achieved a weight loss of ≥15%, while only 2.0% in the placebo group did [9]. - The drug also showed significant improvements in various metabolic indicators, including blood lipids, blood pressure, and liver fat content [9]. Group 2: Significance and Implications - The publication of the study in NEJM signifies international recognition of China's innovative drug development in the field of obesity treatment, providing a new direction for global obesity management [3][6]. - The research results are expected to influence clinical guidelines and practices, contributing to the "Healthy China 2030" initiative by addressing the rising obesity rates in the country [6][10]. - The dual-target mechanism of Masitide, which combines appetite suppression and enhanced fat metabolism, represents a breakthrough in obesity treatment strategies [8][10]. Group 3: Broader Context and Public Health - The increasing prevalence of overweight and obesity in China poses significant public health challenges, with obesity-related deaths accounting for 11.1% of chronic non-communicable disease deaths in 2019 [4]. - The Chinese government has initiated a "Weight Management Year" campaign to address these issues, emphasizing the importance of weight management in improving national health [4][6]. - Experts suggest that obesity treatment should consider local population characteristics and implement differentiated strategies, particularly focusing on liver health and lipid management [6][10].

这项临床研究标志着中国自主研发的创新减重药物临床研究迈入国际领先行列，有望改写国内外超重和肥胖疾病的临床治疗和指南。 当地时间5月25日，《新英格兰医学杂志》（NEJM）公布了一项来自中国研究者的GLP-1类减重创新药玛仕度肽的临床研究成果。这也是中国GLP-1类减重 药乃至整个代谢和内分泌疾病领域的创新药临床研究成果首次登上国际医学权威期刊。 最新公布的研究来自于北京大学人民医院纪立农教授领衔开展的3期、双盲、安慰剂对照试验（GLORY-1）结果。GLORY-1是首个在中国超重或肥胖受试者 中评估玛仕度肽疗效和安全性的三期临床试验，标志着中国自主研发的创新减重药物临床研究迈入国际领先行列，有望改写国内外超重和肥胖疾病的临床治 疗和指南。 他还称，玛仕度肽GLORY-1研究登顶全球最权威的临床医学期刊《新英格兰医学杂志》，不仅代表了中国在内分泌代谢领域的创新研究成果得到了国际认 可，也再次证实中国创新药物的研发能力与生物科技创新水平已走在了全球前列。 具体而言，研究结果显示，在用药48周时，4mg玛仕度肽组和6mg玛仕度肽组体重减轻15%至少的受试者比例分别达到35.7%和49.5%以上。根据本月早些时 候礼 ...