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信达生物(01801):玛仕度肽高剂量9mg上市申请获国家药品监督管理局受理
智通财经网· 2025-11-25 08:40
智通财经APP讯,信达生物(01801)发布公告,信尔美®(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)高剂量9mg用于成人中重度肥胖患者长期体重控制的上市申请已获中国 国家药品监督管理局(NMPA)药品审评中心(CDE)受理。玛仕度肽有望在减重手术之外,为中国中重度 肥胖人群提供一个强效、安全的新治疗选择。 • 此外,研究还观察到玛仕度肽9mg可显著降低部分受试者的肝脏脂肪含量,较基线平均百分比降幅达 71.9%,并在血压、血脂、血尿酸等关键心血管代谢指标及腰围上也展现出显著的全面改善。 • 玛仕度肽9mg的安全性良好,未发现新的安全性信号。 有关GLORY-2研究达成所有终点的详细数据,计划在未来的国际学术期刊或学术大会上公布。 信尔美®(玛仕度肽注射液)9mg是目前唯一采用2步剂量滴定即可实现治疗1年超过20%减重的GLP-1类药 物,其开发为中国中重度肥胖患者提供了减重手术之外的有效体重管理的循证医学证据。玛仕度肽高剂 量9mg上市申请获得受理,从针对广阔超重/肥胖人群的2-4-6mg,到如今针对中重度肥胖人群的3-6- 9mg,这一布局源于深刻的科学洞察与明 ...
信达生物(01801.HK):玛仕度肽高剂量9mg上市申请获国家药监局受理
Ge Long Hui· 2025-11-25 08:37
格隆汇11月25日丨信达生物(01801.HK)宣布,信尔美®(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)高剂量9mg用于成人中重度肥胖患者长期体重控制的上市申请已获中国 国家药品监督管理局("NMPA")药品审评中心("CDE")受理。玛仕度肽有望在减重手术之外,为中国中重 度肥胖人群提供一个强效、安全的新治疗选择。 ...
信达生物(01801) - 自愿公告 - 玛仕度肽高剂量9mg上市申请获国家药品监督管理局受理
2025-11-25 08:30
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 ...
港股异动 信达生物(01801)涨超8% 上半年总产品收入同比增超35% 公司BD潜力及创新产品线获看好
Jin Rong Jie· 2025-08-13 07:47
Group 1 - The core viewpoint of the news is that Innovent Biologics (信达生物) has shown strong financial performance with a significant increase in product revenue, driven by its oncology and comprehensive pipeline [1] - As of the latest report, Innovent Biologics' total product revenue for the first half of 2025 exceeded RMB 5.2 billion, reflecting a year-on-year growth of over 35% [1] - In the second quarter of 2025, the company's total product revenue surpassed RMB 2.7 billion, with a year-on-year increase of over 30% [1] Group 2 - Morgan Stanley has raised the valuation of Innovent Biologics' early-stage assets by 43%, recognizing the company's R&D capabilities and market acceptance [2] - The target price for Innovent Biologics has been increased by 21%, from HKD 90 to HKD 109, while maintaining an "overweight" rating [2] - The potential licensing income for Innovent Biologics is expected to account for 5-7% of its future total revenue, highlighting the strategic importance of licensing in the Chinese biopharmaceutical industry [2]
港股异动 | 信达生物(01801)涨超8% 上半年总产品收入同比增超35% 公司BD潜力及创新产品线获看好
智通财经网· 2025-08-13 06:39
Group 1 - Company shares of Innovent Biologics (01801) rose over 8%, reaching HKD 94.65 with a trading volume of HKD 2.115 billion [1] - In the first half of 2025, the company reported total product revenue exceeding RMB 5.2 billion, maintaining a strong year-on-year growth of over 35% [1] - The second quarter of 2025 saw total product revenue surpassing RMB 2.7 billion, with a year-on-year increase of over 30%, driven by both oncology and comprehensive pipeline [1] Group 2 - Morgan Stanley raised the valuation of early-stage assets by 43%, reflecting the market's increasing recognition of Innovent's R&D capabilities [2] - The target price was adjusted upward by 21%, from HKD 90 to HKD 109, while maintaining an "Overweight" rating [2] - The firm expects potential licensing revenue to account for 5-7% of Innovent's future total revenue, highlighting the strategic importance of licensing in the Chinese biopharmaceutical industry [2]
医药生物行业周报:政策再发力,建议关注脑机接口等医疗器械投资机会-20250811
Donghai Securities· 2025-08-11 13:42
Investment Rating - The report assigns an "Overweight" rating to the pharmaceutical and biotechnology industry, indicating that the industry index is expected to outperform the CSI 300 index by 10% or more over the next six months [35]. Core Insights - The pharmaceutical and biotechnology sector experienced a slight decline of 0.84% from August 4 to August 8, 2025, ranking 31st among 31 sectors and underperforming the CSI 300 index by 2.07 percentage points. The current PE valuation for the sector stands at 30.83 times, which is at the historical median level, with a valuation premium of 144% compared to the CSI 300 index [3][11][18]. - The report highlights the strong performance of the medical device sub-sector, which increased by 2.70%, while other sub-sectors such as biological products and pharmaceutical commerce saw declines [3][11]. - A total of 176 stocks in the sector rose (37.13%), while 287 stocks fell (60.55%) during the same period, with notable gainers including Nanmo Biology (42.48%) and Haichen Pharmaceutical (41.29%) [3][24]. Market Performance - The pharmaceutical and biotechnology sector has shown a year-to-date increase of 21.28%, ranking 5th among 31 sectors and outperforming the CSI 300 index by 16.96 percentage points. All sub-sectors have recorded gains, with chemical pharmaceuticals leading at 38.55% [14][19]. - As of August 8, 2025, the PE valuations for various sub-sectors are as follows: biological products at 38.25 times, chemical pharmaceuticals at 36.08 times, and medical devices at 33.29 times [18][27]. Industry News - Recently, seven government departments, including the Ministry of Industry and Information Technology and the National Health Commission, released a document aimed at promoting the innovation and development of the brain-computer interface industry. The plan outlines goals for technological breakthroughs by 2027 and the establishment of a reliable industrial system by 2030 [4][26][28]. - The report emphasizes the potential of brain-computer interfaces to revolutionize the integration of biological and machine intelligence, with significant policy support expected to accelerate industry growth [4][33]. Investment Recommendations - The report suggests focusing on the medical device sector and companies related to brain-computer interfaces, as well as high-quality stocks in innovative drugs, CXO, medical services, and second-class vaccines [4][33]. - Recommended stocks include Betta Pharmaceuticals, Teva Biopharmaceuticals, Kaili Medical, Anjies, and Huaxia Eye Hospital, with additional attention to stocks like Kelun Pharmaceutical and Qianhong Pharmaceutical [5][33].
信达生物上半年收入增长35%至52亿元,信必乐®和信必敏®持续放量
Cai Jing Wang· 2025-08-08 03:12
Core Insights - The company reported total product revenue exceeding RMB 5.2 billion for the first half of the year, reflecting a strong growth of over 35% year-on-year [1] - In Q2 2025, total product revenue surpassed RMB 2.7 billion, with a year-on-year growth of over 30%, driven by both oncology and comprehensive pipelines [1] Oncology and Comprehensive Pipeline - The oncology treatment sector continues to show strong performance with leading brands and product combinations, while new product revenue contributions are on the rise [1] - The comprehensive product line is gradually releasing its potential, with new growth drivers from products like Xinbile® (Tolebrutinib injection) and Xinbimin® (Tremelimumab N01 injection), which are making progress in marketing and channel access [1] - The approval of the world's first dual receptor agonist for glucagon/GLP-1, Xinermai® (Masitide injection), for weight loss indication by the National Medical Products Administration of China adds a significant product to the company's comprehensive pipeline [1] Product Approvals and Clinical Research - The company has successfully obtained approvals for 16 products, with 2 additional products under review by the National Medical Products Administration of China [1] - Four new drug molecules are currently in Phase 3 or pivotal clinical studies, and approximately 15 new drug candidates have entered clinical research [1]
渤海证券研究所晨会纪要(2025.08.07)-20250807
BOHAI SECURITIES· 2025-08-07 01:47
Market Overview - In July 2025, all major A-share indices rose, with the ChiNext Index showing the highest increase of 8.14% and the Shanghai 50 Index the lowest at 2.36% [2] - The total margin balance in the Shanghai and Shenzhen markets reached 1,978.497 billion yuan, an increase of 133.858 billion yuan from the previous month [2] Company Research: Zhongchong Co., Ltd. (002891) - In the first half of 2025, Zhongchong Co., Ltd. reported revenue of 2.432 billion yuan, a year-on-year increase of 24.32%, and a net profit of 203 million yuan, up 42.56% [14] - The company has made significant progress in its overseas business, achieving revenue of 1.575 billion yuan from international markets, a growth of 17.61% [14] - The pet food segment, particularly the staple food category, saw substantial growth, with revenue reaching 783 million yuan, a remarkable increase of 85.79% [15] Industry Research: Pharmaceutical and Biological Sector - The pharmaceutical and biological sector experienced a significant increase of 13.93% in July 2025, driven by innovative drugs and CXO segments [5] - Key policies supporting the high-quality development of innovative drugs were introduced, which are expected to positively impact the pharmaceutical and medical device sectors [4] - The cumulative revenue of the pharmaceutical manufacturing industry for the first half of 2025 was 1,227.52 billion yuan, reflecting a year-on-year decline of 1.2% [4] Industry Research: Machinery Equipment Sector - The machinery equipment sector outperformed the market with a 9.82% increase from July 6 to August 5, 2025 [7] - The sales of excavators in the first half of 2025 showed a growth rate exceeding 20%, indicating strong domestic demand [7] - The upcoming World Robot Conference is expected to catalyze investment opportunities in humanoid robots [8] Industry Research: Metals Sector - The steel market is expected to experience limited upward momentum due to recent price adjustments, with short-term prices likely to fluctuate [10] - Copper prices are supported by tight supply despite recent adjustments due to U.S. tariffs [10] - The aluminum market may see price increases if actual inventory demand performs well in the upcoming months [11]
苏州工业园区今年已新增6款1类创新药 占全国同期约20%
Core Insights - The approval of innovative drugs is a significant indicator of the new productive forces in the biopharmaceutical industry, with Suzhou Industrial Park accounting for approximately 20% of the new innovative drugs approved in China this year [1][3]. Group 1: Drug Approvals - As of July 10, 2023, Ascentage Pharma's new Bcl-2 selective inhibitor, Lisatoclax, received approval for treating adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma who have undergone prior systemic therapy [1]. - On July 8, 2023, Suzhou Wangshan Wangshui Biopharmaceutical Co., Ltd. and the Shanghai Institute of Materia Medica collaborated to launch a new drug, Semaglutide, for the treatment of erectile dysfunction [1]. - On June 27, 2023, Innovent Biologics' injection, Ma Shidu, was approved for long-term weight management in adults with obesity or overweight, being the first dual receptor agonist for weight loss globally [1]. - On May 29, 2023, the injection of Trastuzumab deruxtecan was approved for treating adult patients with HER2-mutant non-small cell lung cancer who have received prior systemic therapy, marking it as the first antibody-drug conjugate for this indication in China [2]. - On the same day, BeiGene's bispecific antibody, Zhenidamab, was approved for patients with HER2-positive advanced biliary tract cancer, providing a new treatment option [2]. - On January 10, 2023, the approval of the long-acting PCSK9 monoclonal antibody, Rucaparib, was granted for treating high cholesterol levels [2]. Group 2: Industry Development - Since 2006, Suzhou Industrial Park has focused on the biopharmaceutical and health industry, attracting over 2,000 related enterprises, with a projected output value of 165.5 billion yuan by 2024 [3]. - The park has implemented a targeted investment strategy, introducing approximately 300 biopharmaceutical and health projects annually over the past three years [3]. - In May 2023, Suzhou Industrial Park announced an action plan to accelerate the growth of the biopharmaceutical and health industry, aiming to develop over five leading enterprises with international competitiveness and achieve significant sales milestones by 2027 [3].
GLP-1类新药上市一周即“上网”,京东健康缘何领跑减重市场?
Di Yi Cai Jing· 2025-07-07 15:29
Group 1 - The increasing awareness of obesity as a chronic disease and its health risks has led to a growing demand for weight management solutions in China, with a projected adult overweight and obesity rate of 70.5% by 2030 if not effectively addressed [1] - The GLP-1 class of innovative drugs is becoming a focal point for pharmaceutical companies, with significant competition in drug development aimed at treating obesity and overweight conditions [1] - Online platforms are being recognized for their value in connecting patients with medications and providing professional health support services, influencing pharmaceutical companies' partnership selections [1] Group 2 - JD Health successfully launched the weight loss drug Ma Shidu (generic name: Magsduptide injection) on its platform shortly after its approval, marking a significant entry into the weight loss market [2][3][4] - Ma Shidu has four key advantages over previous weight loss medications, including effective improvement of fatty liver disease, clinical trials based on Chinese populations, enhanced convenience and safety in administration, and ongoing clinical trials for various demographics [5] - The collaboration between JD Health and pharmaceutical companies reflects a mutual interest in leveraging online channels for drug sales and health management, with JD Health's platform being a critical player in this transition [6][8] Group 3 - JD Health's partnerships with major pharmaceutical companies, such as the strategic agreement with Novo Nordisk, highlight the shift from merely selling drugs to managing health, emphasizing the importance of online platforms in the healthcare ecosystem [6][9] - The online platform has seen significant user engagement, with nearly 300,000 users purchasing GLP-1 medications during the 618 shopping festival, indicating a threefold increase in sales [9] - JD Health has introduced a multidisciplinary "weight loss clinic" to provide comprehensive services, integrating various medical specialties to support users in their weight management journey [10] Group 4 - The complexity and instability of peptide drugs necessitate stringent cold chain logistics for safe storage and transportation, which has become a competitive factor for online channels [11] - JD Logistics has established a nationwide cold chain distribution network, improving delivery efficiency and ensuring compliance with storage regulations, contributing to JD Health's leading market share of over 70% in the online weight loss category [11]