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]

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 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]

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 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]

港股创新药板块午后走弱，信达生物跌超7%，荣昌生物、绿叶制药跌超4%，药明生物、君实生物、凯 莱英等跟跌。 ...