INNOVENT BIO(01801)

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中国减重药物研究有新突破,业界呼吁完善创新药生态体系
Di Yi Cai Jing· 2025-05-30 06:51
Core Insights - The development of new drugs for obesity treatment in China is gaining momentum, with the recent publication of the phase III clinical study results for the drug Masitide in a top medical journal, indicating a significant advancement in the country's drug development capabilities [1][3] - Masitide is the world's first and only GCG/GLP-1 dual receptor agonist approved for weight loss and glycemic control, highlighting its potential in addressing complex metabolic issues associated with obesity [1][2] Group 1: Drug Development and Clinical Research - The phase III clinical study (GLORY-1) of Masitide has been recognized as a milestone, showcasing China's ability to conduct clinical research at an international level [3] - The dual mechanism of action of Masitide, which combines appetite suppression and metabolic acceleration, is expected to provide a more comprehensive solution for obesity management compared to single-target therapies [1][3] Group 2: Challenges in Drug Development Ecosystem - There is a notable gap in the drug development ecosystem in China compared to international standards, particularly in the transition from basic research to clinical application [3] - The majority of new drug patents in the U.S. are held by companies, while in China, 70-80% are held by research institutions, indicating a need for better integration of research and industry [3] Group 3: Financial and Policy Support - The high failure rate of innovative drug development poses a significant challenge, as the costs of unsuccessful products are absorbed by successful ones, necessitating a robust financial return for companies [4] - The Chinese government is implementing a comprehensive support plan for innovative drug development, focusing on policy coordination across pricing, insurance, and investment to foster a conducive environment for drug innovation [4]
创新药ETF天弘(517380)涨0.8%,年内涨近20%,机构:创新药建议关注创新+业绩共振机会
2 1 Shi Ji Jing Ji Bao Dao· 2025-05-30 02:18
Group 1 - The core viewpoint of the news highlights the significant performance of the innovative drug sector, with the Tianhong Innovative Drug ETF (517380) showing a nearly 20% increase year-to-date as of May 29, 2023 [1] - The Tianhong Innovative Drug ETF, launched in 2021, tracks the "Hang Seng Shanghai-Shenzhen Hong Kong Innovative Drug Selected 50" index, providing comprehensive coverage of the innovative drug industry across A-shares and Hong Kong stocks [1] - On May 29, the National Medical Products Administration approved 11 new drugs, with five being from innovative companies listed on the Sci-Tech Innovation Board, covering various therapeutic areas including oncology and autoimmune diseases [1] Group 2 - The upcoming 2025 ASCO Annual Meeting in Chicago is expected to showcase significant data from domestic innovative drug companies, with 71 original research results from Chinese pharmaceutical companies selected for presentation [2] - The innovative drug sector is anticipated to gain increased attention and positive market sentiment, with institutional holdings currently at low levels and the sector's valuation significantly below historical averages [2] - The total amount of outbound transactions for innovative drugs has reached $45.5 billion since the beginning of 2025, indicating a strong trend towards internationalization and potential for future growth [3] Group 3 - The Chinese innovative drug industry has transitioned from imitation to rapid following and now to original innovation, marking a significant evolution in its development [3] - Most domestic innovative drugs currently in the U.S. are in clinical stages, with future milestones expected to validate the growth and internationalization of Chinese innovative drugs [3]
特朗普关税被叫停!拉爆这一赛道
格隆汇APP· 2025-05-29 10:14
作者 | 哥吉拉 数据支持 | 勾股大数 据(www.gogudata.com) 5月29日,A股主要指数高开高走,截至收盘,沪指涨0.7%报3363点,深证成指涨1.24%,创业板指涨1.37%。全市场近4500股上涨,逾百 股涨停。 板块方面,金融科技、创新药、互联网、半导体等热门板块表现强势,市场情绪相比近日明显提振。 其中,创新药是涨幅最明显的板块之一,睿智医药、舒泰神、益方生物强势斩获20CM涨停,另有十多家医药股涨幅均超过10%,堪称又一轮 暴涨潮。 | 代码 | 名称 | 现价 | 1 9 mm a lond a rither more an a many 143 1994 (310 1 涨跌幅▼ | 年初至今涨跌幅 | 总市值1 | | --- | --- | --- | --- | --- | --- | | 300149 | 睿智医药 | 8.56 c | 20.06% | 33.33% | 43亿 | | 300204 | 舒泰神 | 23.04 c | 20.00% | 210.93% | 110亿 | | 688382 | 益元生物-U | 29.10 c | 20.00% | 11 ...
Innovent Announces a Phase 3 Study of Picankibart (Anti-IL-23p19 Antibody) Completes First Participant Dosing, Exploring Biologics Switching Treatment for Psoriasis Patients with Prior Inadequate Response to Anti-IL-17 Antibodies
Prnewswire· 2025-05-29 01:33
Core Viewpoint - Innovent Biologics has initiated a Phase 3 clinical study for picankibart, targeting psoriasis patients who have not responded adequately to anti-IL-17 treatments, aiming to provide robust clinical evidence for biologic switching strategies in psoriasis treatment [1][4][6]. Company Overview - Innovent Biologics is a leading biopharmaceutical company founded in 2011, focused on developing high-quality medicines for various diseases, including oncologic, autoimmune, cardiovascular, and metabolic conditions [10]. - The company has launched 15 products and has multiple assets in various stages of clinical trials, including 3 new drug applications under regulatory review [10]. Clinical Study Details - The Phase 3 study (NCT06945107) will enroll approximately 310 participants, randomized in a 1:1 ratio to receive either picankibart or continued IL-17 monoclonal antibody treatment [2]. - The primary endpoint is the proportion of participants achieving a static Physician's Global Assessment (sPGA) score of clear (0) or almost clear (1) at week 16 [2]. Efficacy and Safety - Previous Phase 2 studies indicated that switching to picankibart resulted in a rapid clinical response, with 64.6% of patients achieving skin lesion clearance after 16 weeks [3][6]. - Nearly half (48.2%) of participants in the Phase 2 study reached the primary endpoint, with a stable response rate of 54.2% through week 44 [5]. Psoriasis Background - Psoriasis is a chronic inflammatory disease affecting 80%-90% of patients with plaque psoriasis, with nearly 30% classified as moderate-to-severe [7]. - Current systemic treatments include various agents, with biologics becoming a central focus since 2019 due to their efficacy and safety [7]. Picankibart Overview - Picankibart (IBI112) is a monoclonal antibody developed by Innovent, targeting the IL-23p19 subunit, which may offer a more effective treatment option for psoriasis and other autoimmune diseases [8]. - The first new drug application for picankibart for moderate-to-severe plaque psoriasis was submitted for review by the NMPA in September 2024 [9].
速递|中国“减肥神药”登顶《新英格兰医学杂志》,杀入全球减肥赛道!
GLP1减重宝典· 2025-05-28 08:26
整理 | GLP1减重宝典内容团队 信达生物宣布,其 GLORY-1 三期临床研究结果在《新英格兰医学杂志》(NEJM) 上发表。该研究评估了玛仕度肽(一种胰高血糖素 (GCG) 和胰高血糖素样肽-1 (GLP-1) 受体双激动剂)在中国超重或肥胖成年患者中的疗效。 该研究的第一作者是北京大学人民医院的纪立农教授和河南科技大学第一附属医院的蒋宏伟教授。纪立农教授和信达生物的钱镭博士 为共同通讯作者。 这是首个提交监管审批的GCG/GLP-1受体双激动剂玛仕度肽的临床试验首次发表在顶级同行评议期刊上。这也标志着中国研发的创 新肥胖治疗药物首次登上《新英格兰医学杂志》(NEJM),体现了中国在生物制药创新方面的进步。该研究有望为全球肥胖管理临床 指南提供参考。 在NEJM的一篇相关社论中,哈佛大学医学院的Vanita R. Aroda教授和科罗拉多大学安舒茨医学院的Leigh Perreault教授指出了中国 和西方人群在肥胖相关健康结果方面的关键差异。他们强调,中国年轻人出现代谢功能障碍的几率与西方老年人口相当。玛仕度肽不 仅显著降低了体重和BMI,还改善了更广泛的肥胖相关健康指标。他们强调了在中国开展个性化干 ...
信达生物双靶点减重新药登顶NEJM,千亿减重市场迎来“中国方案”
Cai Jing Wang· 2025-05-27 10:19
Core Viewpoint - The article highlights the successful Phase III clinical trial results of the obesity treatment drug Masitide (GCG/GLP-1 dual receptor agonist), which has been published in the prestigious New England Journal of Medicine (NEJM), marking a significant milestone for China's innovation in the field of endocrine metabolism and potentially transforming obesity treatment globally [1][5][10]. Group 1: Clinical Research and Results - The GLORY-1 study, which included 610 participants, demonstrated that Masitide significantly reduced body weight compared to placebo, with 73.9% and 82.0% of participants in the 4 mg and 6 mg groups, respectively, achieving a weight loss of ≥5% by week 32 [9]. - By week 48, 35.7% and 49.5% of participants in the 4 mg and 6 mg groups, respectively, achieved a weight loss of ≥15%, while only 2.0% in the placebo group did [9]. - The drug also showed significant improvements in various metabolic indicators, including blood lipids, blood pressure, and liver fat content [9]. Group 2: Significance and Implications - The publication of the study in NEJM signifies international recognition of China's innovative drug development in the field of obesity treatment, providing a new direction for global obesity management [3][6]. - The research results are expected to influence clinical guidelines and practices, contributing to the "Healthy China 2030" initiative by addressing the rising obesity rates in the country [6][10]. - The dual-target mechanism of Masitide, which combines appetite suppression and enhanced fat metabolism, represents a breakthrough in obesity treatment strategies [8][10]. Group 3: Broader Context and Public Health - The increasing prevalence of overweight and obesity in China poses significant public health challenges, with obesity-related deaths accounting for 11.1% of chronic non-communicable disease deaths in 2019 [4]. - The Chinese government has initiated a "Weight Management Year" campaign to address these issues, emphasizing the importance of weight management in improving national health [4][6]. - Experts suggest that obesity treatment should consider local population characteristics and implement differentiated strategies, particularly focusing on liver health and lipid management [6][10].
行业ETF风向标丨创新药步入发展新阶段,多只港股创新药相关ETF涨超2%
Mei Ri Jing Ji Xin Wen· 2025-05-27 05:35
Market Overview - The market experienced fluctuations in the early session, with the ChiNext Index leading the decline. The focus of the market was primarily on the consumer and pharmaceutical sectors [1] ETF Performance - Several ETFs related to innovative drugs saw significant gains, with the Hong Kong Stock Connect Innovative Drug ETF (159570) rising by 2.61% and the Hong Kong Innovative Drug ETF (159567) increasing by 2.22% [2] - The Hong Kong Innovative Drug ETF (513120) also rose over 2%, with a total scale of 95.23 billion, tracking the CSI Hong Kong Innovative Drug Index [5] Investment Logic - The innovative drug industry in China is expected to reach a turning point by 2025, shifting from capital-driven to profit-driven trends, presenting opportunities for both performance and valuation recovery [2] - A new round of technological advancements is anticipated to propel domestic innovative drugs into a new development phase [2] Key Stocks in Innovative Drug Sector - Notable companies in the innovative drug sector include: - Innovent Biologics (信达生物) with a market cap of 885.89 million - BeiGene (百济神州) with a market cap of 2,034.42 million - WuXi Biologics (药明生物) with a market cap of 938.65 million - Other significant players include CanSino Biologics (康方生物), China Biologic Products (中国生物制药), and Hengrui Medicine (翰森制药) [3][6][7] Index Composition - The CSI Hong Kong Innovative Drug Index selects up to 50 listed companies involved in innovative drug research and development, reflecting the overall performance of the innovative drug sector in the Hong Kong market [5][6]
医药要翻身?创新药继续霸榜!
Mei Ri Jing Ji Xin Wen· 2025-05-27 02:36
Core Viewpoint - The Chinese innovative pharmaceutical sector is gaining international recognition, highlighted by significant deals and promising clinical data, leading to increased interest in related ETFs [1][3][4]. Group 1: Market Performance - The innovative drug ETF (517110) has rebounded nearly 15% since early April, reflecting strong performance in the pharmaceutical sector [1]. - The biopharmaceutical ETF and vaccine ETF also showed positive movements, with respective increases of 1.17% and 0.89% [2]. Group 2: ASCO Conference Insights - At the 2025 ASCO conference, over 70 research outcomes from Chinese pharmaceutical companies were presented, showcasing advancements in ADC and bispecific antibody technologies [3]. - Notable performances include Zai Lab's ZG005 and Huahai Pharmaceutical's HB0025, which exceeded expectations in early clinical trials for cervical and endometrial cancers, respectively [3]. Group 3: Business Development Trends - Recent business development (BD) activities in the innovative drug sector have seen record-breaking upfront payments, such as the $12.5 billion upfront payment from Pfizer for a PD-1/VEGF bispecific antibody from 3SBio [4][7]. - The increase in upfront payments and total deal values indicates growing international recognition of Chinese innovative drugs [7]. Group 4: Future Outlook - The innovative drug sector is expected to benefit from ongoing BD transactions, advancements in artificial intelligence across the pharmaceutical value chain, and the implementation of new healthcare policies [7]. - The overall sentiment and valuation in the pharmaceutical sector may improve due to domestic policy optimizations and a recovery in medical equipment procurement [7].
再度反弹!创新药沪深港ETF盘中涨超2%
Mei Ri Jing Ji Xin Wen· 2025-05-27 02:29
Core Viewpoint - The Hong Kong pharmaceutical sector is experiencing a strong performance, with notable gains in stocks such as WuXi Biologics, Innovent Biologics, China National Pharmaceutical Group, and others, reflecting a positive trend in the innovative drug market [1][4]. Group 1: Market Performance - The innovative drug ETF (517110) saw an intraday increase of over 2% [1]. - Major pharmaceutical stocks, including WuXi Biologics and Innovent Biologics, rose by more than 2% [1]. Group 2: Catalysts and Developments - A significant catalyst for the sector is the licensing agreement between 3SBio and Pfizer regarding the PD-1/VEGF bispecific antibody SSGJ-707, marking a milestone with an upfront payment exceeding $1 billion, showcasing the competitiveness of Chinese innovative drugs internationally [4]. - The upcoming ASCO conference is expected to highlight numerous original research outcomes from Chinese pharmaceutical companies, indicating their rapid advancement in innovative R&D [4]. Group 3: Industry Fundamentals - The overall net profit of the pharmaceutical sector decreased by 11.4% year-on-year, but the innovative drug segment showed a positive growth of 4.3% [5]. - The success rate for innovative drugs in the upcoming 2024 medical insurance negotiations is projected to exceed 90%, with domestic products accounting for over 70% [5]. - The pharmaceutical industry is expected to benefit from optimized procurement policies, domestic demand recovery, and continuous technological advancements, leading to a potential valuation recovery [5].
中国原创减肥药登上NEJM:效果媲美司美格鲁肽,且因副作用而停药的概率更低
生物世界· 2025-05-26 02:52
Core Viewpoint - The article discusses the promising results of Mazdutide, a dual agonist of GLP-1 and GCG receptors, in weight management and its potential impact on obesity treatment guidelines globally [2][3]. Group 1: Drug Mechanism and Development - Mazdutide activates GLP-1 receptors to suppress appetite and delay gastric emptying, while also activating GCG receptors to promote liver fat breakdown and enhance energy expenditure, addressing both weight loss and fatty liver issues [2]. - The clinical trial results of Mazdutide were published in the prestigious New England Journal of Medicine, marking a significant milestone for Chinese drug development in the field of metabolic and endocrine diseases [3][6]. Group 2: Clinical Trial Results - In a Phase 3, double-blind, placebo-controlled trial involving 610 participants, the average weight loss at 32 weeks for the 6 mg group was 12.55% (approximately 11 kg), and at 48 weeks, it was 14.01% (approximately 12 kg) [6][9]. - The trial showed that 49.5% of participants in the 6 mg group lost over 15% of their body weight, indicating significant efficacy in weight management [9]. Group 3: Safety and Side Effects - The most commonly reported adverse events were gastrointestinal-related, primarily mild to moderate, with a low incidence of treatment discontinuation due to side effects: 0.5% in the 6 mg group compared to higher rates in similar drugs [8][9]. - The study confirmed the high safety profile of Mazdutide, with side effects concentrated in the initial treatment phase [8].