恒瑞医药（600276）(600276.SH)发布公告，近日，公司收到国家药品监督管理局(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/RPTCL)成人患者。泽美妥司他片是中国首个自主研发的 EZH2抑制剂。 ...

Group 1 - The Hong Kong pharmaceutical sector experienced a significant rise, with the Hang Seng Biotechnology Index closing up over 5%, driven by favorable policies and strong performance in earnings [1] - The National Healthcare Security Administration announced the adjustment list for the 2025 medical insurance and commercial insurance innovative drug directory, which includes several heavyweight innovative drugs, enhancing market access expectations [1] - Several pharmaceutical companies reported robust performance in the first half of the year, such as BeiGene with a 46% year-on-year revenue growth and achieving half-year profitability for the first time, and Heng Rui Medicine reaching record highs in revenue and profit, improving the sector's attractiveness [1] Group 2 - The international collaboration and overseas expansion of innovative drugs have become significant catalysts, with Chinese pharmaceutical companies completing 83 license-out transactions totaling over $84.5 billion, setting a historical record [1] - The partnership between 3SBio and Pfizer, valued at $6.05 billion for dual antibody licensing, highlights global market recognition of domestic innovative drugs [1] - Hong Kong has recently introduced simplified registration policies that recognize mainland review data, facilitating internationalization for innovative drug companies and further expanding industry growth potential [3] Group 3 - The upcoming global academic conferences, such as the World Lung Cancer Conference in September and the European Society for Medical Oncology Annual Meeting in October, will see multiple companies showcasing core clinical data, which may serve as short-term stock price catalysts [3] - Institutions believe that the long-term logic of the innovative drug sector remains unchanged, and the expectation of interest rate cuts by the Federal Reserve is strengthening liquidity, leading to continued capital allocation towards leading Hong Kong pharmaceutical stocks [4]

Core Viewpoint - The weight loss drug sector has shown a significant increase, with a rise of 2.99% as of September 1, ranking it seventh among concept sectors, driven by strong performances from several stocks [1][2]. Group 1: Sector Performance - The weight loss drug sector saw 48 stocks increase in value, with notable gainers including Baihua Pharmaceutical (up 10.91%), Dezhan Health (up 10.00%), and Health元 (up 9.98%) [1][2]. - Conversely, stocks such as Sichuan Shuangma, Nawei Technology, and Deyuan Pharmaceutical experienced declines, with drops of 3.73%, 3.61%, and 1.64% respectively [1][2]. Group 2: Capital Flow - The weight loss drug sector attracted a net inflow of 1.528 billion yuan, with 35 stocks receiving net inflows, and 6 stocks exceeding 100 million yuan in net inflows [2][3]. - Leading the net inflow was Heng Rui Pharmaceutical, which saw a net inflow of 524 million yuan, followed by Fosun Pharmaceutical (233 million yuan), Health元 (213 million yuan), and Yi Pin Hong (128 million yuan) [2][3]. Group 3: Stock Specifics - Health元, Dezhan Health, and Baihua Pharmaceutical had the highest net inflow ratios at 28.67%, 26.23%, and 16.34% respectively [3]. - Specific stock performances included Heng Rui Pharmaceutical (up 3.20% with a turnover rate of 1.37%), Fosun Pharmaceutical (up 6.38% with a turnover rate of 4.71%), and Health元 (up 9.98% with a turnover rate of 3.05%) [3][4].

Core Viewpoint - Heng Rui Medicine (600276.SH) has received conditional approval from the National Medical Products Administration for its self-developed innovative drug, SHR2554 tablets, which is the first EZH2 inhibitor developed in China, aimed at adult patients with relapsed or refractory peripheral T-cell lymphoma who have previously undergone at least one line of systemic therapy [1] Company Summary - The company has developed SHR2554 tablets, marking a significant milestone as it is the first EZH2 inhibitor independently developed in China [1] - The approval is specifically for adult patients with relapsed or refractory peripheral T-cell lymphoma, indicating a targeted therapeutic application [1] Industry Summary - The approval of SHR2554 tablets highlights advancements in the oncology sector, particularly in the development of innovative treatments for complex hematological malignancies [1] - The introduction of the first EZH2 inhibitor in the Chinese market may enhance competition and innovation within the pharmaceutical industry, particularly in the field of cancer treatment [1]

拟定适应症(或功能主治)：本品适用于在控制饮食和增加运动基础上，初始体重指数(BMI)符合以下要 求的成人的长期体重管理：≥28kg/m2(肥胖)，或≥24kg/m2(超重)并伴有至少一种体重相关合并症(例如高 血糖、高血压、血脂异常、阻塞性睡眠呼吸暂停、脂肪肝等)。 智通财经APP讯，恒瑞医药(600276.SH)发布公告，近日，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(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。 ...

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]

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]

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 ...

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 ...

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]