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]

Market Overview - The Hong Kong stock market showed a significant recovery on November 24, with all three major indices ending a streak of declines[9] - Large tech stocks performed strongly, with Kuaishou rising over 7%, and NetEase and Bilibili increasing over 5%[9] - The Hang Seng Tech Index closed at 5,546, up 2.78% for the day and 24.11% year-to-date[3] Sector Performance - Innovative pharmaceuticals and outsourcing concepts saw notable gains, with companies like Innovent Biologics rising over 6%[9] - Military stocks also performed well, with China Shipbuilding Defense up over 13%[9] - Oil stocks were weak, with China National Offshore Oil Corporation and China Oilfield Services both declining over 1%[9] U.S. Market Insights - On the same day, U.S. markets saw all three major indices close higher, driven by increased bets on a Federal Reserve rate cut[9] - The "Magnificent Seven" tech stocks, including Google and Nvidia, all rose, with Google gaining over 6%[9] - The S&P 500 index is projected to achieve double-digit annual growth according to HSBC strategists[14] Economic Indicators - The Federal Reserve is expected to cut rates in December, with market predictions showing a 70% probability[14] - The U.S. economy's third-quarter GDP report has been delayed due to a government shutdown, affecting economic analysis[14] Investment Trends - The Nasdaq Golden Dragon China Index rose by 2.82%, indicating a positive trend for Chinese concept stocks[13] - Significant inflows into semiconductor stocks were noted, with companies like Broadcom surging 11%[13]

Core Viewpoint - Innovent Biologics has announced the acceptance of a supplementary application for the 9 mg dosage of mazdutide, a dual receptor agonist, aimed at long-term weight management in adults with moderate to severe obesity in China, addressing a significant unmet clinical need [1][2]. Group 1: Clinical Study Results - The Phase 3 clinical study GLORY-2 demonstrated that participants receiving mazdutide 9 mg achieved a mean weight reduction of 18.55%, compared to 3.02% in the placebo group, with 44.0% of participants in the mazdutide group losing 20% or more of their weight [4]. - The study also showed significant reductions in liver fat content (71.9% reduction) and improvements in key cardiometabolic parameters, including blood pressure and blood lipids, with no new safety signals identified [4][5]. Group 2: Treatment Context - In China, individuals with severe obesity face limited treatment options, with metabolic surgery being the current first-line recommendation, which is invasive and not widely applicable [2]. - Mazdutide 9 mg is positioned as a promising alternative to metabolic surgery, potentially filling a major clinical gap in obesity treatment [2][4]. Group 3: Product Development and Strategy - Innovent has conducted or completed seven Phase 3 clinical studies of mazdutide, with the first five meeting their primary endpoints, and ongoing studies in various obesity-related conditions [6]. - The company has entered into an exclusive license agreement with Eli Lilly for the development and commercialization of mazdutide in China, highlighting its strategic partnerships and market focus [5][13]. Group 4: Recognition and Future Prospects - Mazdutide has been recognized in top-tier journals and was selected as one of the "Top 10 Most Anticipated Drug Launches of 2025" by FIERCE Pharma, indicating strong market expectations [7][8]. - The drug is the first innovative treatment in China's endocrinology and metabolism field to have clinical results published in The New England Journal of Medicine, underscoring its clinical significance [8].

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 Insights - The Chinese innovative drug industry has reached a new watershed in 2025, characterized by significant transactions and a shift towards quality over quantity in drug development [5][7][8]. Group 1: Industry Evolution - The year 2025 marks the tenth anniversary of the Chinese innovative drug industry, described as a year of "frenzy" due to major transactions such as 60.5 billion USD partnership between 3SBio and Pfizer, 12.5 billion USD collaboration between Hengrui Medicine and GSK, and 11.4 billion USD deal between Innovent Biologics and Takeda [6][8]. - License-out upfront payments reached 4.55 billion USD in the first three quarters of 2025, surpassing the total financing amount of 3.19 billion USD in the primary market, indicating that BD transactions have become a crucial cash flow pillar during a capital winter [6][22]. - The approval speed of new drugs has accelerated, with 43 new drugs approved in the first half of 2025, a 59% increase year-on-year, and 26 innovative drugs approved by October [14][20]. Group 2: Market Dynamics - The total amount of BD transactions in the Chinese pharmaceutical sector exceeded 100 billion USD, with 103 license-out transactions totaling 92.03 billion USD in the first three quarters, a 77% year-on-year increase [16][20]. - The oncology field remains the core battlefield, with 63 projects going overseas in the first three quarters, while the endocrine and metabolic fields have also seen significant growth [16][22]. - The U.S. is the primary acquirer in license-out transactions, accounting for 49% of the total, followed by Germany, South Korea, and Switzerland [22]. Group 3: Financial Performance - The innovative drug sector achieved a revenue of 48.83 billion CNY in the first three quarters of 2025, a 22.1% year-on-year increase, with a notable profit turnaround for leading companies [41][43]. - Leading companies like BeiGene and Innovent Biologics reported significant profits, with BeiGene achieving a net profit of 1.139 billion CNY in the first three quarters [41][43]. - The financial performance of small biotech firms contrasts sharply, with many facing severe funding challenges and some, like NuoHui Health, being forced to delist due to financial misconduct [40][43]. Group 4: Challenges and Opportunities - Despite the industry's growth, deep-seated challenges remain, including insufficient late-stage clinical development capabilities and the phenomenon of "selling early-stage pipelines at a discount" [25][36]. - The gap in clinical trial capabilities between domestic companies and multinational corporations (MNCs) is evident, with MNCs leveraging their resources to dominate core clinical resources in China [30][33]. - The proportion of license-out transactions for late-stage projects has only slightly increased, indicating a continued reliance on early-stage assets [26][36].

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]