每经记者｜许立波 每经编辑｜魏官红 近年来，GLP-1受体激动剂类药物因在血糖控制、体重管理以及心血管等方面的综合获益为2型糖尿病 患者提供了更好的治疗选择。 依据信达生物方面提供的新闻稿，玛仕度肽此次获批降糖适应证，主要基于两项在中国开展的Ⅲ期临床 研究结果：DREAMS-1研究验证了其单药治疗的疗效与安全性，DREAMS-2研究则考察了其与口服降糖 药联合应用的效果。两项研究覆盖了最常见的两类糖尿病患者群体——单药治疗患者和口服药物控制不 佳的患者。结果显示，玛仕度肽在血糖控制和体重管理方面均优于安慰剂或度拉糖肽1.5毫克，同时还 能改善多项心血管、肝脏及肾脏相关的代谢指标。 除上述已完成的3项研究外，玛仕度肽目前还有4项Ⅲ期临床研究正在进行，研究对象涵盖中重度肥胖、 超重或肥胖合并代谢相关脂肪性肝病（MAFLD）、合并肥胖的阻塞性睡眠呼吸暂停（OSA）等人群， 并在合并肥胖的2型糖尿病患者中开展与司美格鲁肽的头对头对比研究。 封面图片来源：视觉中国-VCG41182058084 在减重方面，玛仕度肽今年6月以信尔美的商品名在国内获批，成为全球首个GCG/GLP-1双受体激动减 重药物。作为首款国产GLP ...

Core Insights - Innovent Biologics has received approval from China's National Medical Products Administration (NMPA) for mazdutide, a first-in-class dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist, aimed at glycemic control in adults with type 2 diabetes (T2D) [1][6][16] - Mazdutide is expected to provide comprehensive benefits in glycemic control, weight reduction, and improvements in hepato-cardio-renal metabolic indicators, addressing the urgent need for effective diabetes management in China [5][9][11] Industry Context - China has the highest prevalence of T2D globally, with approximately 140 million adults affected, representing 1 in 4 cases worldwide [2][12] - The treatment paradigm for diabetes is shifting towards a comprehensive, patient-centric management strategy that includes glycemic control, weight management, and cardiovascular risk factor mitigation [3][10] Clinical Evidence - The approval of mazdutide was based on two Phase 3 clinical trials (DREAMS-1 and DREAMS-2), which demonstrated its superiority over placebo and dulaglutide in glycemic control and weight reduction [6][7][11] - In DREAMS-1, at Week 24, the mean changes in HbA1c for the mazdutide 4 mg and 6 mg groups were -1.57% and -2.15%, respectively, compared to -0.14% for placebo [6] - In DREAMS-2, at Week 28, the mean changes in HbA1c for the mazdutide 4 mg and 6 mg groups were -1.69% and -1.73%, respectively, compared to -1.38% for dulaglutide [6] Safety and Administration - Mazdutide exhibited a safety profile consistent with previous GLP-1 receptor agonists, with no new safety signals identified [7] - The mazdutide injection device features significant improvements in convenience and safety, including a hidden needle design and single-use functionality, enhancing patient comfort and adherence [8] Future Implications - The approval of mazdutide aligns with the "Healthy China 2030" vision, aiming to improve disease management and reduce the burden of T2D in the population [5][11] - Innovent Biologics has plans for further clinical studies and potential new indications for mazdutide, indicating a commitment to advancing diabetes treatment options [14][15]

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） ...

Core Viewpoint - The company Sinopharm Biologics announced that its product, Masitide Injection, has received approval from the National Medical Products Administration for a new indication to control blood sugar in adults with type 2 diabetes, making it the world's first dual receptor agonist for GCG/GLP-1 in diabetes treatment [1] Group 1 - The new indication approval follows the previous approval in June for weight loss, marking the second indication for the drug this year [1]

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 ...

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 announcement indicates that Innovent Biologics has received approval from the National Medical Products Administration (NMPA) in China for the new drug application (NDA) of its dual receptor agonist, Masituzumab injection, for the treatment of blood sugar control in adult patients with type 2 diabetes [1] Group 1 - Innovent Biologics announced the approval of Masituzumab injection for a second indication [1] - The drug is a dual receptor agonist targeting glucagon (GCG) and glucagon-like peptide-1 (GLP-1) [1] - The approval is specifically for use in adult patients with type 2 diabetes [1]

Core Viewpoint - The approval of the new drug application for Masitide injection by the NMPA marks a significant advancement in diabetes management in China, being the first GCG/GLP-1 dual receptor agonist approved for type 2 diabetes [1] Company Summary - Sinopharm's Masitide injection has received approval for its second indication, aimed at blood sugar control in adult patients with type 2 diabetes [1] - The drug is expected to provide multiple benefits for the management of type 2 diabetes, including blood sugar control, weight loss, and improvements in heart, liver, and kidney indicators [1] Industry Summary - The approval of Masitide positions it as a pioneering treatment option in the diabetes care market, potentially enhancing disease management for a large population of type 2 diabetes patients in China [1]

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，並明確表示，概不對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。 信達生物製藥 INNOVENT BIOLOGICS, INC. （於開曼群島註冊成立的有限公司） （股份代號：1801） 自願公告 瑪仕度肽獲中國國家藥品監督管理局 批准用於成人2型糖尿病患者的血糖控制 本公告由信達生物製藥（「本公司」，連同其附屬公司統稱「本集團」）自願作出，以 告知本公司股東及潛在投資者本集團最新業務更新。 本公司董事會（「董事會」）欣然宣佈，瑪仕度肽注射液（胰高血糖素[GCG]╱胰高 血糖素樣肽-1[GLP-1]雙受體激動劑）的第二項適應症新藥上市申請（「NDA」）獲 中國國家藥品監督管理局（「NMPA」）批准上市，用於成人2型糖尿病患者的血糖 控制。瑪仕度肽是全球首個獲批的用於2型糖尿病的GCG/GLP-1雙受體激動劑， 有望助力中國廣大2型糖尿病患者人群疾病管理，實現血糖控制、減重及心肝腎 指標多重獲益。 中國2型糖尿病患者人數居世界首位，長期血糖管理及併發症防治需求嚴峻 中國 ...

Group 1 - The overnight SPDR S&P Biotech ETF (XBI) rose by 3.1%, while the Hong Kong pharmaceutical sector (159718.SZ) opened high but continued to weaken, currently down by 0.93% [1] - Among the constituent stocks, Haijia Medical (06078) led the gains with an increase of 7.41%, while Innovent Biologics (01801) saw the largest decline at 6.57% [1] - Industrial insights suggest that the innovative drug sector's prosperity is sustainable, with a focus on "innovation + internationalization" as the core direction of the pharmaceutical sector [1] Group 2 - The innovative drug industry is expected to continue receiving policy support, enhancing the global competitiveness of Chinese innovative drugs and realizing commercial profitability [1] - There is an improvement in the fundamentals of the innovative drug supply chain, with overseas orders and performance beginning to recover, and domestic business showing a self-controllable logic [1] - The demand in the domestic market is anticipated to recover by 2025, with potential improvements in the consumption medical field and medical devices [1] Group 3 - Institutions remain confident in high-quality innovation and the innovative industry chain, viewing any external disturbances as buying opportunities [2] - The Hong Kong pharmaceutical ETF is well-balanced, including innovative drugs, CXO, internet healthcare, and innovative devices, serving as a convenient standardized tool for investors [2] - Recommendations are made to pay attention to the Hong Kong pharmaceutical ETF (159718.SZ) and its connected funds (Class A: 019598, Class C: 019599) [2]