Core Viewpoint - The company, Innovent Biologics, announced that its GCG/GLP-1 dual receptor agonist, Masitide, has received acceptance for a marketing application from the National Medical Products Administration (NMPA) in China for long-term weight control in adults with moderate to severe obesity [1] Group 1 - The marketing application for Masitide is specifically for a high dosage of 9mg [1] - The target patient population for this drug includes adults suffering from moderate to severe obesity [1] - The acceptance by NMPA's Center for Drug Evaluation (CDE) marks a significant step in the drug's commercialization process in China [1]

Core Viewpoint - The application for the high-dose 9mg of Xinermy® (Mastudipeptide injection) for long-term weight control in adults with moderate to severe obesity has been accepted by the National Medical Products Administration (NMPA) in China, providing a new effective and safe treatment option beyond weight loss surgery for this population [1][2]. Group 1: Clinical Study Results - The application is based on the outstanding results of the Phase III clinical study GLORY-2, where the 9mg group showed an average weight reduction of 18.55% at week 60, compared to 3.02% in the placebo group, with 44.0% of participants achieving a weight loss of 20% or more [1][2]. - In participants without type 2 diabetes, the 9mg group achieved an average weight reduction of 20.08% at week 60, while the placebo group had a reduction of 2.81%, with 48.7% of the 9mg group achieving a weight loss of 20% or more [2]. - The study also noted a significant reduction in liver fat content, with an average percentage decrease of 71.9% from baseline, along with improvements in key cardiovascular metabolic indicators such as blood pressure, blood lipids, blood uric acid, and waist circumference [2]. Group 2: Safety and Regulatory Aspects - The safety profile of the 9mg dosage is favorable, with no new safety signals identified [2]. - The company plans to collaborate closely with regulatory authorities to expedite the approval of this important therapy to serve a broad patient population [3]. Group 3: Market Positioning - Xinermy® (Mastudipeptide injection) 9mg is currently the only GLP-1 class drug that can achieve over 20% weight loss in one year through a two-step dosing titration, providing evidence-based medicine for effective weight management in moderate to severe obesity patients [3]. - The development strategy has evolved from targeting a broad overweight/obese population with 2-4-6mg dosages to now focusing on moderate to severe obesity with 3-6-9mg dosages, reflecting deep scientific insights and clear market demand for personalized treatment solutions [3].

Core Viewpoint - The application for the high-dose 9mg of Xinermy (Mastideptin injection) for long-term weight control in adults with moderate to severe obesity has been accepted by the National Medical Products Administration (NMPA) in China, indicating a potential new treatment option for this demographic beyond weight loss surgery [1] Group 1 - Xinermy is a dual receptor agonist for glucagon ("GCG") and glucagon-like peptide-1 ("GLP-1") [1] - The drug is expected to provide a strong and safe treatment alternative for the moderately to severely obese population in China [1]

INNOVENT BIOLOGICS, INC. （於開曼群島註冊成立的有限公司） （股份代號：1801） 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 自願公告 瑪仕度肽高劑量9mg上市申請 獲國家藥品監督管理局受理 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」）欣然宣布，信爾美® （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）高劑量9mg用於成人中重度 肥胖患者長期體重控制的上市申請已獲中國國家藥品監督管理局（「NMPA」）藥品 審評中心（「CDE」）受理。瑪仕度肽有望在減重手術之外，為中國中重度肥胖人群 提供一個強效、安全的新治療選擇。 本次上市申請基於瑪仕度肽9mg在中國中重度肥胖人群中開展的III期註冊臨床研 究GLORY-2(NCT06164873)的卓越結果。該研究近期達成了 ...

Core Viewpoint - The innovative drug market has seen a significant surge, with Innovent Biologics experiencing over 150% growth year-to-date and a market capitalization exceeding HKD 160 billion [1] Group 1: Market Performance - The Hang Seng Biotechnology Index, which heavily invests in Innovent Biologics and BeiGene, has risen over 80% this year, ranking among the top in overall market indices [1] - The Hang Seng Medical ETF (159892) leads its category with a scale exceeding HKD 6 billion [1] Group 2: Upcoming Developments - The futures for the Hang Seng Biotechnology Index are set to be listed on the Hong Kong Stock Exchange on November 28, providing new risk hedging tools for investors [1] - Innovent Biologics will be included in the Hang Seng Index and the Hang Seng China Enterprises Index, with changes effective after market close on December 5 and effective on December 8 [1] Group 3: Fund Inflows - According to CICC's estimates, the ETF tracking the Hang Seng Index has a fund scale of approximately USD 29.2 billion, while those tracking the China Enterprises and Hang Seng Technology indices have scales of about USD 7.59 billion and USD 32.61 billion, respectively [1] - Innovent Biologics is expected to see an estimated inflow of over USD 364 million due to its inclusion in these indices [1]

Core Insights - The successful inclusion of Innovent Biologics (stock code: 01801.HK) in the Hang Seng Index marks a significant milestone, recognizing its value in the international capital market as a leading biopharmaceutical company [1][2][3] - Innovent Biologics has established a diverse pipeline of innovative drugs targeting major diseases such as cancer, autoimmune disorders, and metabolic diseases, with 16 products already commercialized [2] - The inclusion in the Hang Seng Index reflects the growing recognition and preference for high-quality Chinese innovative pharmaceutical companies in the Hong Kong stock market [2] Company Overview - Innovent Biologics focuses on developing monoclonal antibodies, bispecific antibodies, ADCs, and small molecule drugs, demonstrating continuous leadership in technological innovation and clinical value [2] - The company has optimized its operational efficiency and financial structure, building a solid foundation for long-term development and gaining widespread trust from global investors [2] Market Impact - The inclusion in the Hang Seng Index not only highlights Innovent Biologics' benchmark status in the industry but also serves as a new model for the internationalization of China's biotechnology sector [2] - The founder and CEO of Innovent Biologics emphasized that this milestone will broaden the investor base and enhance international market exposure, providing robust capital support for ongoing innovation and global business expansion [3]

Core Viewpoint - The announcement by Innovent Biologics regarding the successful completion of the GLORY-2 Phase III clinical trial for its GCG/GLP-1 dual receptor agonist, Ma Shidu, provides a new non-invasive weight loss option for the significant population of obese individuals in China, showing efficacy comparable to weight loss surgery [1][2][3] Group 1: Clinical Trial Results - The GLORY-2 trial achieved its primary endpoint and all key secondary endpoints, demonstrating significant weight loss in participants with a baseline BMI over 34 kg/m², with an average weight reduction of 20.08% compared to placebo [1][2] - The study included 462 participants, with a 2:1 random allocation to the Ma Shidu 9 mg group or placebo, and a treatment duration of 60 weeks [2] - Improvements were noted in various metabolic indicators, including waist circumference, systolic blood pressure, triglycerides, non-HDL cholesterol, LDL cholesterol, and uric acid levels, with good tolerability and safety [1][2][3] Group 2: Market Implications - The high obesity prevalence in China, particularly among individuals with a BMI over 30 kg/m², highlights the need for effective non-invasive treatment options for this patient group, which currently relies heavily on metabolic surgery [1][2] - The successful results of the GLORY-2 trial position Ma Shidu as a promising new treatment option for managing obesity and related metabolic syndromes, potentially transforming the treatment landscape for this demographic [2][3] - Innovent Biologics plans to submit a marketing application for Ma Shidu 9 mg to the National Medical Products Administration (NMPA) to expedite access to this treatment for the Chinese population [3]

信达生物(1801.HK)获纳入恒指成份股及国指成份股，今日股价表现强势，一度涨近5%报91.6港元。各 指数成份股变动将于12月5日(星期五)收市后实施，并于12月8日(星期一)起生效。 ...

Core Insights - The Hong Kong stock market opened positively on November 24, with the Hang Seng Index rising by 0.92%, the Hang Seng Tech Index by 1.13%, and the Hang Seng China Enterprises Index by 0.81% [1] - Notable sectors included technology stocks, gold stocks, innovative drug concepts, lithium battery stocks, and automotive stocks, indicating active market participation and strong capital interest [1] - The inclusion of Innovent Biologics, a significant biotech company, into the Hang Seng Index reflects the growing recognition and importance of quality Chinese innovative drug companies in the mainstream capital market [1] Market Performance - The Hang Seng Index and related ETFs, such as the Hang Seng ETF (159920) and Hang Seng China Enterprises ETF (159850), experienced a strong opening and continued to rise throughout the trading session [1] - The market showed active trading with significant attention from investors, highlighting a positive sentiment towards the Hong Kong stock market [1] Company Developments - Innovent Biologics has become the fourth innovative drug company to be included in the Hang Seng Index, joining other companies that have transitioned from traditional pharmaceuticals to innovative drug enterprises [1] - This inclusion signifies a benchmark status for Innovent Biologics and underscores the increasing focus on high-quality Chinese biotech firms in the international market [1]

每经AI快讯，信达生物(01801.HK)一度涨近5%，截至发稿，涨3.9%，报90.65港元，成交额1.77亿港 元。 ...