11月20日，中国创新药企信达生物（01801.HK）宣布，其自主开发的全球首个GCG/GLP-1双受体激动 剂玛仕度肽在中国BMI≥30kg/m²中重度肥胖人群的III期临床研究GLORY-2，达成主要终点及所有关键次 要终点。 GLORY-2研究结果显示，与安慰剂相比，玛仕度肽9mg组实现显著的体重减轻，以及腰围、收缩压、甘 油三酯、非高密度脂蛋白胆固醇、低密度脂蛋白胆固醇和血尿酸的显著下降。 ●第60周时，玛仕度肽9mg组受试者平均体重降幅为18.55%，安慰剂组为3.02%；玛仕度肽9mg组受试 者中44.0%实现20%及以上的体重降幅，安慰剂组这一比例为2.6%。 ●在不合并2型糖尿病的单纯性肥胖受试者中，第60周时，玛仕度肽9mg组受试者平均体重降幅为 20.08%，安慰剂组为2.81%；玛仕度肽9mg组受试者中48.7%实现20%及以上的体重降幅，安慰剂组这一 比例为3.1%。 研究数据显示，相较于安慰剂，玛仕度肽9mg治疗实现显著的体重减轻，特别是在单纯性肥胖受试者中 平均体重降幅为20.08%，同时显著改善多项代谢指标。 信达生物表示，即将提交9mg用于成人体重控制的上市申请。这意味着，BM ...

消息面上，11月20日，信达生物宣布，玛仕度肽注射液(IBI362)在中国中重度肥胖人群中开展的III期临 床研究(GLORY-2)达成主要终点和所有关键次要终点，信达生物将于近期向监管机构递交玛仕度肽9mg 用于成人体重控制的新药上市申请。 公开资料显示，玛仕度肽是信达生物与礼来制药共同推进的一款胰高血糖素(GCG)/胰高血糖素样 肽-1(GLP-1)双受体激动剂，也是全球首个获批的GCG/GLP-1双受体激动剂。该药已在国内获批两项适 应症，分别用于成人肥胖或超重患者的长期体重控制以及成人2型糖尿病患者的血糖控制。 信达生物(01801)尾盘涨近3%，截至发稿，涨2.62%，报92港元，成交额7.47亿港元。 ...

Core Insights - The article highlights that Innovent Biologics has achieved a significant milestone with its GCG/GLP-1 dual receptor agonist, Ma Shidu Peptide, demonstrating superior efficacy in blood glucose control and weight management compared to Semaglutide in the DREAMS-3 Phase III clinical trial [1][3][4] Group 1: Clinical Trial Results - The DREAMS-3 trial is the first head-to-head Phase III clinical study comparing a GCG/GLP-1 dual receptor agonist with Semaglutide in diabetes treatment, marking a breakthrough for domestic innovative drugs [1][3] - After 32 weeks of treatment, 48% of Ma Shidu Peptide patients achieved both blood glucose targets (HbA1c < 7.0%) and weight loss of ≥10%, significantly higher than the 21% in the Semaglutide group [3][4] - Ma Shidu Peptide showed an average blood glucose reduction of 2.03% compared to 1.84% for Semaglutide, and an average weight loss of 10.29% versus 6.00% [3][4] Group 2: Safety and Tolerability - The overall tolerability of Ma Shidu Peptide is good, with a low discontinuation rate due to adverse events and no new safety signals reported [4] - Common adverse events were mild to moderate gastrointestinal reactions, with a low incidence of hypoglycemia comparable to Semaglutide, and no reports of severe hypoglycemia [4] Group 3: Market Potential and Innovation - The GLP-1 drug market is projected to exceed $100 billion by 2030, driven by strong demand for effective and safe treatments for obesity and metabolic disorders [6] - Ma Shidu Peptide is the first and only GCG/GLP-1 dual receptor agonist approved for both weight management and type 2 diabetes treatment, positioning it as a competitive player in the market [6][8] - The innovative design of the injection pen, featuring a hidden needle and single-use format, enhances patient convenience and compliance, which is crucial for long-term treatment adherence [6][8]

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].

Core Viewpoint - The approval of Masitide, a dual receptor agonist for GCG/GLP-1, marks a significant milestone for the company and the diabetes treatment landscape in China [1] Group 1: Product Approval - Masitide has received approval from the National Medical Products Administration for use in blood sugar control in adult patients with type 2 diabetes [1] - This product is the first globally approved GCG/GLP-1 dual receptor agonist, developed in collaboration with Eli Lilly [1] Group 2: Market Potential - Masitide was previously approved in June 2025 for long-term weight management in adult patients in China [1]

Core Viewpoint - The approval of the new drug application (NDA) for Masitide injection, a dual receptor agonist for glucagon (GCG) and glucagon-like peptide-1 (GLP-1), marks a significant advancement in the treatment of type 2 diabetes in China, addressing the urgent need for effective blood sugar control and weight management among the country's large diabetic population [1][2][5] Industry Overview - China has the highest number of adult diabetes patients globally, with approximately 140 million individuals, accounting for about one-quarter of the world's diabetic population [2] - The management of diabetes is evolving from mere blood sugar control to a more comprehensive approach that includes patient-centered strategies focusing on blood sugar, weight management, and the prevention of cardiovascular and renal complications [2] Product Details - Masitide is the first approved GCG/GLP-1 dual receptor agonist for type 2 diabetes, expected to provide multiple benefits including blood sugar control, weight loss, and improvements in cardiovascular, liver, and kidney health [1][3][5] - The approval is based on two Phase III clinical studies demonstrating that Masitide outperforms placebo and dulaglutide 1.5mg in terms of blood sugar control and weight loss, while also improving various metabolic indicators [3][4] Safety and Efficacy - The safety profile of Masitide is consistent with previous studies of other GLP-1 receptor agonists, with no new safety risks identified [4] - The innovative injection pen for Masitide enhances convenience and safety, featuring a hidden needle design to reduce injection anxiety and a single-use mechanism to minimize contamination risks [4] Future Outlook - The successful launch of Masitide reflects the regulatory authority's recognition of its clinical value and safety, reinforcing the company's strength in metabolic treatment innovation [5] - The company aims to continue its focus on developing high-quality biopharmaceuticals across various therapeutic areas, including oncology, autoimmune diseases, metabolism, cardiovascular health, and ophthalmology, aligning with the goal of achieving "Healthy China 2030" [5]

Core Viewpoint - The approval of the new drug application (NDA) for Masitide (GCG/GLP-1 dual receptor agonist) by the National Medical Products Administration (NMPA) in China marks a significant advancement in the treatment of type 2 diabetes, providing a new option for blood sugar control in adult patients [1][5]. Group 1: Industry Context - China has the highest number of type 2 diabetes patients globally, with approximately 140 million adults affected, accounting for about one-quarter of the world's diabetic population [2]. - The management of diabetes has shifted towards a comprehensive strategy that includes not only blood sugar control but also weight management and the prevention of cardiovascular and renal complications [2]. Group 2: Product Details - Masitide is the first GCG/GLP-1 dual receptor agonist approved for type 2 diabetes, offering benefits in blood sugar control, weight loss, and improvements in cardiovascular, liver, and kidney health [3][5]. - The approval is based on two Phase III clinical studies demonstrating that Masitide outperforms placebo and Dulaglutide 1.5mg in terms of blood sugar control and weight loss, while also improving various metabolic indicators [3][4]. Group 3: Safety and Administration - The safety profile of Masitide is consistent with previous studies of GLP-1 receptor agonists, with no new safety risks identified [4]. - The new injection pen for Masitide features a hidden needle design to reduce injection anxiety and is a single-use device, minimizing contamination risks [4]. Group 4: Future Outlook - The successful launch of Masitide reflects the recognition of its clinical value and safety by regulatory authorities, reinforcing the company's innovation capabilities in metabolic treatments [5]. - The company aims to continue its focus on developing high-quality biopharmaceuticals across various therapeutic areas, including oncology, autoimmune diseases, metabolism, cardiovascular health, and ophthalmology [5].

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].

Core Insights - The article discusses the significant results of the DREAMS-1 clinical trial for the dual receptor agonist, IBI362 (Mastudutide), developed by Innovent Biologics, focusing on its efficacy in treating type 2 diabetes patients in China [1][2]. Group 1: Clinical Trial Results - The DREAMS-1 study achieved its primary and all key secondary endpoints by July 2024, demonstrating that Mastudutide effectively lowers blood sugar and promotes weight loss while positively impacting cardiovascular and renal metabolic indicators [1]. - The study included 320 Chinese type 2 diabetes patients with an average age of 50.4 years and a baseline HbA1c of 8.24%. Participants were randomly assigned to receive either 4 mg or 6 mg of Mastudutide or a placebo for 24 weeks [2]. Group 2: Efficacy in Glycemic Control - At 24 weeks, the HbA1c levels decreased by 1.57% and 2.15% for the 4 mg and 6 mg groups, respectively, compared to a mere 0.14% in the placebo group. The proportion of patients achieving HbA1c <7.0% was 68.6% and 87.4% for the treatment groups, while only 10.7% in the placebo group [3]. Group 3: Weight Loss Outcomes - Mastudutide also showed significant weight loss benefits, with the 4 mg and 6 mg groups experiencing weight reductions of 5.61% and 7.81%, respectively, compared to 1.26% in the placebo group. Additionally, 50.9% and 69.0% of patients in the treatment groups lost ≥5% of their body weight, while only 7.3% in the placebo group achieved this [5]. Group 4: Safety Profile - The overall tolerability of Mastudutide was good, with gastrointestinal adverse effects being the most common, primarily occurring during the titration phase. The incidence of hypoglycemia was low, with no severe cases reported, and the safety profile was consistent with previous studies [5].

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]