Hengrui Pharma(600276)
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恒瑞医药(600276.SH):泽美妥司他片获得药品注册批准,是中国首个自主研发的EZH2抑制剂
Ge Long Hui A P P· 2025-09-01 09:04
Core Viewpoint - Heng Rui Medicine has received conditional approval from the National Medical Products Administration for its self-developed innovative drug, SHR2554 tablets, for adult patients with relapsed or refractory peripheral T-cell lymphoma who have received at least one line of systemic therapy [1] Group 1: Product Development - SHR2554 tablets are the first self-developed EZH2 inhibitor in China [1] - The drug is a new, efficient, and selective oral EZH2 inhibitor [1] - The total R&D investment for the SHR2554 project has reached approximately 213 million yuan [1] Group 2: Market Context - In January 2020, the U.S. FDA approved the oral EZH2 inhibitor Tazverik (tazemetostat) developed by Epizyme [1] - In August 2021, Hutchison China MediTech obtained the development and commercialization rights for tazemetostat in Greater China [1] - Tazverik's global sales are projected to be approximately 51 million USD in 2024 according to EvaluatePharma [1]
恒瑞医药(600276.SH):HRS9531注射液药品上市许可申请获受理
Ge Long Hui A P P· 2025-09-01 09:04
Core Viewpoint - Heng Rui Medicine's subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has received the acceptance notice from the National Medical Products Administration for the drug listing application of HRS9531 injection, indicating progress in the company's product pipeline and potential market entry for a new diabetes treatment [1] Company Summary - HRS9531 injection is a novel dual agonist targeting GLP-1R and GIPR, with global independent intellectual property rights [1] - The drug aims to regulate glucose and lipid metabolism, suppress appetite, and enhance insulin sensitivity, thereby improving blood sugar levels and aiding weight loss [1]
恒瑞医药(600276) - 恒瑞医药关于获得药品注册批准的公告
2025-09-01 09:00
证券代码:600276 证券简称:恒瑞医药 公告编号:临 2025-133 江苏恒瑞医药股份有限公司 关于获得药品注册批准的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 近日,江苏恒瑞医药股份有限公司(以下简称"公司")收到国家药品监督 管理局(以下简称"国家药监局")的通知,附条件批准公司自主研发的 1 类创 新药泽美妥司他片(SHR2554 片)上市,用于既往接受过至少 1 线系统性治疗的 复发或难治外周 T 细胞淋巴瘤(R/R PTCL)成人患者。泽美妥司他片是中国首个 自主研发的 EZH2 抑制剂,现将相关情况公告如下: 一、药品的基本情况 药品名称:泽美妥司他片 剂型:片剂 规格:50mg 注册分类:化学药品 1 类 批准的适应症:用于既往接受过至少 1 线系统性治疗的复发或难治外周 T 细胞淋巴瘤成人患者。 二、药品的其他情况 外周 T 细胞淋巴瘤(PTCL)是一组具有高度异质性和侵袭性的淋巴系统恶性 肿瘤,在我国非霍奇金淋巴瘤患者中,其占比约 25-30% [1],明显高于西方国家; 且患者中位发病年龄为 ...
恒瑞医药(600276) - 恒瑞医药关于药品上市许可申请获受理的提示性公告
2025-09-01 09:00
药品名称:HRS9531 注射液 剂型:注射剂 受理号:CXHS2500106、CXHS2500107、CXHS2500108、CXHS2500109、 CXHS2500110、CXHS2500111、CXHS2500112、CXHS2500113、CXHS2500114 证券代码:600276 证券简称:恒瑞医药 公告编号:临 2025-134 江苏恒瑞医药股份有限公司 关于药品上市许可申请获受理的提示性公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 近日,江苏恒瑞医药股份有限公司(以下简称"公司")子公司福建盛迪医 药有限公司收到国家药品监督管理局(以下简称"国家药监局")下发的《受理 通知书》,公司 HRS9531 注射液的药品上市许可申请获国家药监局受理。现将相 关情况公告如下: 一、药品的基本情况 药品从研制、临床试验报批到投产的周期长、环节多,药品研发及至上市容 易受到一些不确定性因素的影响,敬请广大投资者谨慎决策,注意防范投资风险。 公司将按国家有关规定积极推进上述研发项目,并及时对项目后续进展情况履行 信 ...
恒瑞医药:HRS9531注射液上市申请获国家药监局受理
Xin Lang Cai Jing· 2025-09-01 08:54
Core Viewpoint - The company has received acceptance for the drug listing application of HRS9531 injection, which is aimed at long-term weight management for adults with obesity or overweight conditions [1] Group 1: Product Development - HRS9531 injection is intended for adults with an initial body mass index (BMI) of ≥28 kg/m² or those with a BMI of ≥24 kg/m² accompanied by at least one weight-related comorbidity [1] - The drug achieved all primary and key secondary endpoints in the Phase III clinical trial conducted in July 2025, demonstrating good safety and tolerability [1] - The total research and development investment for the HRS9531 project has reached approximately 452 million yuan [1] Group 2: Regulatory and Future Plans - The company will advance the project development in accordance with national regulations and will disclose progress in a timely manner [1]
化学制药板块9月1日涨3.54%,迈威生物领涨,主力资金净流入12.45亿元
Zheng Xing Xing Ye Ri Bao· 2025-09-01 08:44
Group 1 - The chemical pharmaceutical sector increased by 3.54% on September 1, with Maiwei Biotech leading the gains [1] - The Shanghai Composite Index closed at 3875.53, up 0.46%, while the Shenzhen Component Index closed at 12828.95, up 1.05% [1] - Notable gainers in the chemical pharmaceutical sector included Maiwei Biotech, which rose by 20.00% to a closing price of 57.60, and Xingqi Eye Medicine, which increased by 14.65% to 77.54 [1] Group 2 - The chemical pharmaceutical sector saw a net inflow of 1.245 billion yuan from main funds, while retail funds experienced a net outflow of 41.1167 million yuan [2] - The top stocks by main fund inflow included Heng Rui Medicine with 474 million yuan and Fuxing Medicine with 256 million yuan [3] - Conversely, stocks like Duorui Medicine and ST Suwu experienced significant declines, with Duorui Medicine down 9.36% to 41.17 [2][3]
恒瑞医药:公司2025年上半年营业收入157.6亿元,其中对外许可收入19.9亿元
Mei Ri Jing Ji Xin Wen· 2025-09-01 08:18
每经AI快讯,有投资者在投资者互动平台提问: 请问2025年上半年扣除对外许可收入后的营业额和利 润增长率是多少? 恒瑞医药(600276.SH)9月1日在投资者互动平台表示,公司2025年上半年营业收入157.6亿元,其中对 外许可收入19.9亿元。公司归属于上市公司股东的净利润44.5亿元,同比增长29.7%。详细信息请查阅 公司2025年半年度报告"经营情况的讨论与分析"部分内容。 (文章来源:每日经济新闻) ...
港股异动 | 医药股再度走强 上半年药企业绩整体表现稳健 机构看好创新药长期向好逻辑
Zhi Tong Cai Jing· 2025-09-01 06:38
Group 1 - Pharmaceutical stocks in Hong Kong have shown strong performance, with notable gains in companies such as 加科思-B (up 23.18%), 三叶草生物-B (up 22.09%), and others [1] - The overall performance of Hong Kong pharmaceutical companies in the first half of the year has been robust, with 恒瑞医药 achieving record high revenue and profit, and 翰森制药 exceeding revenue expectations [1] - Upcoming major conferences, including the World Lung Cancer Conference (WCLC) and the European Society for Medical Oncology (ESMO), will showcase research results from innovative domestic drugs [1] Group 2 - 海通国际 maintains a positive outlook on Hong Kong pharmaceutical companies due to their stable cash flow, rich R&D pipelines, and normalizing external licensing revenues [2] - The recent slight pullback in the Hong Kong pharmaceutical sector is attributed to rapid fund rotation, with expectations of short-term fluctuations [2] - The long-term value reassessment logic in the pharmaceutical industry remains unchanged, supported by the engineer dividend and a rich catalyst environment in the innovative drug industry [2]
中报验证业绩反转,政策技术双驱动,医疗健康ETF(159828)早盘上涨2.35%,迎来复苏窗口
Sou Hu Cai Jing· 2025-09-01 04:56
截至2025年9月1日午间收盘,医疗健康ETF泰康(159760)上涨2.35%,成交274.28万元。跟踪指数国证公 共卫生与医疗健康指数(980016)强势上涨2.54%,成分股长春高新(000661)上涨10.00%,健康元(600380) 上涨9.98%,华海药业(600521)上涨8.73%,百济神州(688235),惠泰医疗(688617)等个股跟涨。 业内机构分析指出,2025年半年报披露,医疗健康行业整体呈现出"先抑后扬"的走势。此前受到集采政 策与需求波动的影响,部分细分领域业绩承压,但从二季度开始,行业底部迹象逐步显现。医疗器械板 块二季度单季利润同比下滑幅度已经收窄,三季度有望迎来新一轮增长拐点。与此同时,创新药与 CRO企业在中报中展现出强劲反弹,部分企业收入增速甚至超市场预期。这表明医疗健康行业不仅没 有失速,反而正在进入估值与业绩双重修复的关键阶段。 医疗健康ETF泰康(159760),场外联接(A类:020093;C类:020094); 政策的积极支持为行业反转提供了坚实基础。8月18日,国务院正式批复《中国(江苏)自由贸易试验 区生物医药全产业链开放创新发展方案》,提出要在审批 ...
重研发强“内功”上市公司“创新底色”愈加彰显
Zhong Guo Zheng Quan Bao· 2025-09-01 01:21
Core Insights - The article highlights the significant role of technological innovation in driving high-quality development for companies, particularly in the context of the ongoing technological revolution and industrial transformation [1][2]. R&D Investment and Performance - In the first half of the year, listed companies in China accelerated their innovation efforts, with R&D investment exceeding 810 billion yuan, a year-on-year increase of 3.27% [2]. - The overall R&D intensity reached 2.33%, with notable figures for different boards: 4.89% for the ChiNext, 11.78% for the Sci-Tech Innovation Board, and 4.63% for the Beijing Stock Exchange [2]. - 113 listed companies invested over 1 billion yuan in R&D, while 926 companies had an R&D intensity exceeding 10% [2]. - BYD topped the list with R&D investment of 30.88 billion yuan, followed by several companies like China State Construction, ZTE, and China Mobile, each investing over 5 billion yuan [2]. Company Innovations - BYD's R&D investment grew by 53.05% year-on-year, leading to the launch of groundbreaking technologies and products, including the world's first mass-produced passenger car high-voltage architecture [3]. - Hikvision focused on multi-dimensional perception, AI, and big data technologies, enhancing product innovation and expanding its smart IoT business [3]. - Shenyang Chemical achieved a turnaround with a net profit of 62.42 million yuan, emphasizing product innovation and market responsiveness [4]. Industry Leaders and Their Impact - Industry leaders play a crucial role in driving innovation and technological breakthroughs, particularly in sectors like new energy and innovative pharmaceuticals [4][6]. - CATL, a leader in the new energy sector, has established multiple R&D centers and manufacturing bases globally, launching innovative products in both passenger and commercial vehicle segments [5][6]. AI Integration in Business - AI has become a focal point for R&D among listed companies, with significant advancements reported in cloud computing and home appliance sectors [7][8]. - Companies like Industrial Fulian and Gree Electric have seen substantial growth in AI-related revenues, with Gree's AI dynamic energy-saving products experiencing a 360% increase in sales [7][8]. - The government's policies are encouraging the integration of AI into business strategies, aiming to enhance operational efficiency and drive innovation across industries [8].