Core Viewpoint - The approval of the second indication for the drug Masitide injection by the National Medical Products Administration marks a significant advancement for the company in the treatment of type 2 diabetes, following its earlier approval for weight management [2][3]. Group 1: Product Approval and Features - Masitide injection has received approval for blood sugar control in adult patients with type 2 diabetes, following its earlier approval for weight loss in June [2]. - The injection pen features a hidden needle design and is a single-use device, utilizing X-cut technology to reduce injection pain [2]. Group 2: Clinical Research and Efficacy - Masitide is the world's first approved dual receptor agonist for GCG/GLP-1, improving insulin secretion and insulin resistance [2]. - The approval is based on two phase III clinical studies conducted in China, demonstrating that Masitide outperforms placebo and Dulaglutide 1.5mg in blood sugar control and weight management for adult type 2 diabetes patients [2]. - The drug also shows improvements in various cardiovascular, liver, and kidney-related metabolic indicators [2]. Group 3: Weight Management Results - In weight management, clinical studies indicate that patients treated with Masitide experienced an average weight loss of 21%, over 80% reduction in liver fat content, and reductions in waist and neck circumference [3]. - Multiple health indicators, including blood sugar, blood pressure, blood lipids, uric acid, and transaminases, have also shown improvement [3]. Group 4: Ongoing Research - Currently, there are four ongoing phase III clinical studies for Masitide, targeting populations with moderate to severe obesity, metabolic-related fatty liver disease (MAFLD), and obstructive sleep apnea (OSA) associated with obesity [3]. - A head-to-head comparison study with Semaglutide is being conducted among obese type 2 diabetes patients [3].

9月19日，信达生物发布公告称，其玛仕度肽获国家药监局批准上市，用于成人2型糖尿病患者的血糖控 制。玛仕度肽是全球首个获批的GCG/GLP-1双受体激动剂，由信达生物与礼来制药共同开发。2025年6 月，玛仕度肽已在国内获批，用于成人患者长期体重控制。（智通财经记者 陈杨） ...

信达生物(01801)发布公告，玛仕度肽注射液(胰高血糖素(GCG)/胰高血糖素样肽-1(GLP-1)双受体激动 剂)的第二项适应症新药上市申请(NDA)获中国国家药品监督管理局(NMPA)批准上市，用于成人2型糖 尿病患者的血糖控制。玛仕度肽是全球首个获批的用于2型糖尿病的GCG/GLP-1双受体激动剂，有望助 力中国广大2型糖尿病患者人群疾病管理，实现血糖控制、减重及心肝肾指标多重获益。 中国2型糖尿病患者人数居世界首位，长期血糖管理及并发症防治需求严峻 中国成人糖尿病患者人数达1.4亿，居世界第一，约占全球患病人数的四分之一。糖尿病病程长，长期 高血糖可导致心血管疾病、肾病、视网膜病变和神经病变等严重并发症，不仅威胁患者生命健康，也给 家庭和社会带来巨大的经济负担。 近年来，糖尿病的治疗理念逐渐由血糖控制过渡到"以患者为中心"、同时兼顾血糖管理、体重管理、心 血管危险因素及肝心肾合并症及并发症的2型糖尿病综合管理策略。 美国糖尿病协会(ADA)与欧洲糖尿病学会(EASD)联合发布的2型糖尿病高血糖的管理共识报告将"减 重"正式列入2型糖尿病管理目标之一，减重应作为改善血糖控制和降低体重相关并发症风险的治 ...

中国成人糖尿病患者人数达1.4亿，居世界第一，约占全球患病人数的四分之一。糖尿病病程长，长期 高血糖可导致心血管疾病、肾病、视网膜病变和神经病变等严重并发症，不仅威胁患者生命健康，也给 家庭和社会带来巨大的经济负担。 近年来，糖尿病的治疗理念逐渐由血糖控制过渡到"以患者为中心"、同时兼顾血糖管理、体重管理、心 血管危险因素及肝心肾合并症及并发症的2型糖尿病综合管理策略。 美国糖尿病协会(ADA)与欧洲糖尿病学会(EASD)联合发布的2型糖尿病高血糖的管理共识报告将"减 重"正式列入2型糖尿病管理目标之一，减重应作为改善血糖控制和降低体重相关并发症风险的治疗策 略，部分2型糖尿病患者应将减重5%-15%作为治疗首要目标。 玛仕度肽控糖减重优效，代谢肝心肾指标综合获益，助力健康中国2030 GCG/GLP-1双受体激动剂在GLP-1受体激动剂的基础上激动GCG受体，同时改善胰岛素分泌不足和胰岛 素抵抗两大糖尿病核心致病机制，帮助糖尿病患者更好的控制血糖，同时，还能为2型糖尿病患者带来 额外减重及心血管、肝酶改善、肾脏代谢的综合获益。因此，玛仕度肽作为安全、有效并且便捷的新型 治疗选择，可满足2型糖尿病患者长期血糖 ...

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].

Core Insights - The clinical study of the innovative weight-loss drug, Masitide, developed in China, has reached international leading status, potentially transforming clinical treatment and guidelines for overweight and obesity both domestically and internationally [1][4]. Group 1: Clinical Study Details - The study published in the New England Journal of Medicine (NEJM) is led by Professor Ji Linong from Peking University People's Hospital and is the first Phase III, double-blind, placebo-controlled trial (GLORY-1) assessing the efficacy and safety of Masitide in overweight or obese Chinese participants [1][4]. - The GLORY-1 trial set a weight loss target of 5%-15% within 3-6 months for overweight and mildly obese patients, with nearly half of the participants achieving a weight loss greater than 15% [4][5]. Group 2: Drug Development and Market Potential - Masitide is the world's first and only GCG/GLP-1 dual receptor agonist for weight loss and glycemic control, co-developed by Innovent Biologics and Eli Lilly, with commercialization rights in China secured in 2019 [4]. - The drug is expected to be approved for market in China this year, targeting both weight loss and glycemic control indications [4]. Group 3: Research Significance and Global Recognition - The publication of the GLORY-1 study in a prestigious journal signifies international recognition of China's innovative research in the field of endocrine metabolism [5]. - The study highlights the unique characteristics and treatment needs of the Chinese population regarding obesity, contrasting with existing guidelines primarily based on data from Caucasian populations [4][5]. Group 4: Comparative Efficacy - At 48 weeks of treatment, the proportion of participants achieving at least 15% weight loss in the 4mg and 6mg Masitide groups were 35.7% and 49.5%, respectively [5]. - In comparison, a recent head-to-head study of competing GLP-1 weight-loss drugs showed that 64.6% and 40.1% of patients achieved similar weight loss with alternative treatments [5].