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恒瑞医药(01276.HK)获得HRS-5041片临床试验批准通知书
Ge Long Hui· 2025-07-31 10:13
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS-5041, a new drug aimed at treating prostate cancer, indicating a significant advancement in its product pipeline [1] Group 1: Product Development - HRS-5041 is a novel, efficient, and selective AR-PROTAC small molecule developed by the company [1] - The drug demonstrates significant degradation effects on wild-type and various mutant AR proteins, showing potential to overcome resistance compared to second-generation AR inhibitors [1] - Currently, there are no similar products approved for market in both domestic and international markets [1] Group 2: Financial Investment - The cumulative research and development investment for the HRS-5041 project has reached approximately 69.19 million yuan [1]
恒瑞医药(01276):拟用于治疗前列腺癌的HRS-5041获批开展临床试验
智通财经网· 2025-07-31 10:09
HRS-5041 是公司开发的新型、高效、选择性的 AR-PROTAC(雄激素受体-蛋白降解靶向嵌合体)小分 子,拟用于治疗前列腺癌。HRS-5041 对野生型及各类突变体的 AR 蛋白有显着的降解作用,与二代 AR 抑制剂相比,有克服耐药的潜力。经查询,目前国内外暂无同类产品获批上市。截至目前,HRS- 5041 片相关项目累计研发投入约 6,919 万元。 智通财经APP讯,恒瑞医药(01276)公布,近日,公司及子公司成都盛迪医药有限公司收到国家药品监督 管理局核准签发关于 HRS-5041 片的《药物临床试验批准通知书》,将于近期开展临床试验。 ...
恒瑞医药(01276.HK):SHR-8068注射液、阿得贝利单抗注射液、贝伐珠单抗注射液临床试验获批
Ge Long Hui· 2025-07-31 10:06
贝伐珠单抗是一种人源化抗VEGF单克隆抗体,由中外制药和罗氏的子公司基因泰克合作开发,2004年 由美国食品药品监督管理局批准上市,商品名为Avastin(安维汀),目前已在中国和全球多个国家上市销 售。公司的贝伐珠单抗注射液已于2021年6月获批上市,国内目前有多个贝伐珠单抗注射液获批上市。 经查询,2024年贝伐珠单抗全球销售额约为56.55亿美元。截至目前,贝伐珠单抗注射液相关项目累计 研发投入约34,494万元。 阿得贝利单抗注射液是公司自主研发的人源化抗PD-L1单克隆抗体,能通过特异性结合PD-L1分子从而 阻断导致肿瘤免疫耐受的PD-1/PD-L1通路,重新激活免疫系统的抗肿瘤活性,从而达到治疗肿瘤的目 的。公司阿得贝利单抗注射液(商品名:艾瑞利)已于2023年3月获批上市,获批的适应症为与卡铂和依 托泊苷联合用于广泛期小细胞肺癌患者的一线治疗。国外有同类产品Atezolizumab(商品名: Tecentriq)、Avelumab(商品名:Bavencio)和Durvalumab(商品名:Imfinzi)于美国获批上市销售,其中 Atezolizumab和Durvalumab已在中国获批上市。 ...
恒瑞医药(01276) - 海外监管公告 - 关於获得药物临床试验批准通知书的公告
2025-07-31 10:03
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,並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:1276) 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 根據中華人民共和國的有關法例規定,江蘇恒瑞醫藥股份有限公司(「本公司」)在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下,僅供參閱。 孫飄揚先生 中國上海 2025年7月31日 於本公告日期,董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生;(ii)非執行董事郭叢照女士;及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。 证券代码:600276 证券简称:恒瑞医药 公告编号:临 2025-111 江苏恒瑞医药股份有限公司 关于获得药物临床 ...
恒瑞医药(01276) - 海外监管公告 - 关於获得药物临床试验批准通知书的公告
2025-07-31 09:56
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,並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:1276) 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 根據中華人民共和國的有關法例規定,江蘇恒瑞醫藥股份有限公司(「本公司」)在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下,僅供參閱。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 中國上海 2025年7月31日 於本公告日期,董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生;(ii)非執行董事郭叢照女士;及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。 证券代码:600276 证券简称:恒瑞医药 公告编号:临 2025-11 ...
A+H上市潮涌!天岳先进通过聆讯,欣旺达、云天励飞同日递表
Sou Hu Cai Jing· 2025-07-31 08:00
7月30日,全球第二大碳化硅衬底制造商天岳先进通过港交所聆讯;同日,锂电巨头欣旺达及AI推理芯片产品服务提供商云天励飞也正式向港交所递交了 上市申请。 与此同时,进入7月以来,多家A股公司接连披露赴港上市计划,包括首创证券、利欧股份、中微半导等,计划赴港上市的A股公司队伍持续扩容。 据统计,截至7月30日,共有236家企业排队申请港股上市,已递表的A股上市公司达到42家。 10家企业完成"A+H"两地上市 据统计,年内共有10家企业成功赴港上市,合计募资达882.86亿港元,其中,宁德时代募资额达到410.06亿港元,成为今年以来全球最大的IPO项目,恒 瑞医药、三花智控和海天味业募资额紧随其后,均超过100亿港元。 | 证券代码 | 公司名称 | 募资额(亿港元) | 暗盘涨跌幅 | 上市首日涨跌幅 | 上市至今涨跌幅 | 上市日期 | | --- | --- | --- | --- | --- | --- | --- | | 06613.HK | 蓝思科技 | 47.68 | 3.85% | 9.13% | 8.91% | 2025/7/9 | | 01304.HK | Fortior | 22.59 | ...
交银国际维持理想汽车中性评级
Xin Lang Cai Jing· 2025-07-31 07:23
高盛就保诚(02378.HK)发布研报称,预计保诚第二季新业务利润增长将加快,同比增长15%,上半年经 营自由盈余总额将录强劲增长。高盛微调预测,将H股目标价由147港元下调至134港元,重申"买入"评 级。预计香港市场将成为主要增长动力,中期而言,自2027财年起,保诚可达到40%或以上的OFSG分 派率,并将继续上升。 瑞银华宝:维持恒瑞医药买入评级 目标价87.3港元 智通财经7月31日讯(编辑 童古 汤赞淇)以下为各家机构对港股的最新评级和目标价: 交银国际:维持理想汽车中性评级 目标价103.7港元 交银国际就理想汽车(02015.HK)发布研报称,该公司新车型理想i8定价虽然优于预期,但在配置上较消 费者的预期或有落差,同时下半年有多款30万元级别六座SUV新车型上市,该价格带将成为红海市场。 该行维持全年销量预测56万辆,较2024年增长10.7%。 高盛:维持保诚买入评级 下调目标价至134港元 摩根大通:维持老铺黄金增持评级 目标价1249港元 摩根大通就老铺黄金(06181.HK)发布研报称,该公司新开精品店表现强劲,预计2025年下半年势头将持 续,受品牌价值、产品创新及市场对"国牌"的 ...
智通AH统计|7月30日
智通财经网· 2025-07-30 08:19
智通财经APP获悉,截止7月30日收盘,东北电气(00042)、弘业期货(03678)、复旦张江(01349)分列AH 溢价率前三位,溢价率分别为743.75%、227.43%、209.05%;宁德时代(03750)、恒瑞医药(01276)、招 商银行(03968)分列AH溢价率末三位,溢价率分别为-20.05%、-3.78%、2.23%。其中安德利果汁 (02218)、金力永磁(06680)、钧达股份(02865)的偏离值位居前三,分别为22.99%、20.11%、17.87%;另 外,东北电气(00042)、中州证券(01375)、国联民生(01456)的偏离值位居后三,分别 为-187.10%、-46.82%、-39.59%。 前十大AH股溢价率排行 前十大AH股偏离值排行 | 股票名称 | H股(港元) | A股 | 溢价率↓ | 偏离值 | | --- | --- | --- | --- | --- | | 东北电气(00042) | 0.320 | 2.25 | 743.75% | -187.10% | | 弘业期货(03678) | 4.520 | 12.36 | 227.43% | -1.00 ...
国金证券:慢阻肺蓝海疗法迭代 国产新药BD潜力凸显
智通财经网· 2025-07-30 03:10
Group 1 - The core viewpoint is that the large patient base for COPD and the limitations of traditional treatment options create a significant opportunity for innovative therapies, which are expected to reshape the treatment landscape and generate substantial market growth [1][2]. - COPD is a prevalent chronic disease in China, affecting approximately 100 million people, and is the third leading cause of death in 2021, highlighting the urgent need for better treatment options [1]. - The current awareness and standardized treatment rates for COPD in China are low, with only 0.9% awareness and 4.5% lung function testing rates, indicating a significant opportunity for improvement in diagnosis and treatment [1]. Group 2 - Recent approvals of innovative therapies, such as ensifentrine and dupilumab, have broken the long-standing absence of new mechanism drugs in the COPD field, leading to an accelerated iteration of treatment options [2]. - The FDA approved ensifentrine in June 2024 as the first new mechanism inhalation product for COPD maintenance treatment in over 20 years, representing a significant advancement in therapy [2]. - Merck's acquisition of Verona for approximately $10 billion underscores the value of innovative COPD treatments and the potential for further market expansion [2]. Group 3 - Chinese innovative pharmaceutical companies are actively developing key targets for COPD treatment, with notable progress in the PDE3/4 inhibitor space, exemplified by companies like Hengrui Medicine and China Biologic Products [3]. - Hengrui Medicine's innovative drug HRS-9821 has entered a collaboration agreement with GSK, which includes a $500 million upfront payment and a potential total deal value of around $12 billion, highlighting the global recognition of Chinese innovation [3]. - The ongoing development of various innovative pipelines in the COPD sector indicates a promising future for Chinese companies in securing external licensing opportunities [3].
恒瑞医药20250728
2025-07-30 02:32
Summary of the Conference Call for 恒瑞医药 Company Overview - **Company**: 恒瑞医药 (Hengrui Medicine) - **Industry**: Pharmaceutical Key Points and Arguments Financial Projections - 恒瑞医药 expects revenue for 2025, 2026, and 2027 to be 35.77 billion, 42.4 billion, and 50.8 billion RMB respectively, with net profit attributable to shareholders projected at 9.3 billion, 11.5 billion, and 13.7 billion RMB respectively, indicating strong growth potential [2][4][23] Strategic Partnerships - A significant collaboration with GSK was established, involving a $500 million upfront payment and $12 billion in milestone payments, covering PDE3/4 inhibitors and 11 preclinical projects in oncology, respiratory, and autoimmune inflammation, which will significantly enhance revenue in 2025 [2][4][7][23] Pipeline Development - 恒瑞医药 has over 30 pipelines with potential for external licensing, covering respiratory, oncology, and autoimmune fields, despite not leading in the PD-1 VGF and ADC sectors [2][3][8][22] Respiratory Sector Performance - The company has shown strong performance in the respiratory sector, with its PDE3/4 inhibitors being among the first to enter clinical trials in China, and the development of DPI formulations enhancing medication convenience [9][10][11] Competitive Landscape - The acquisition of the Firozane asset by Merck for $10 billion has extended the life of the COPD sector, benefiting Chinese companies and potentially prompting AstraZeneca to strengthen its presence in this area [12][18][19] Globalization Strategy - 恒瑞医药 is implementing a "less but better" strategy, focusing on high-quality innovative drugs for overseas development and has engaged in significant partnerships with multinational pharmaceutical companies [17][21] Future Development Potential - The company is expected to continue expanding its innovative pipeline, with 133 projects in development, including emerging technologies like AR Protec, CGT drugs, and mRNA cancer vaccines, which are anticipated to enter clinical stages in the coming years [17][21][22] BD (Business Development) Potential - 恒瑞医药's strong clinical data disclosure enhances its BD potential, with a mix of assets ready for licensing and those with internal data that may not yet be publicly disclosed, indicating a robust pipeline for future collaborations [21][22] Recent Developments - The recent partnership with GSK has validated 恒瑞医药's strong willingness for external licensing and strategic transformation, leading to an upward revision of the company's profit forecast for 2025 [23] Additional Important Insights - The company is actively participating in international conferences to showcase clinical data and promote business development collaborations, enhancing its global competitiveness [17][21] - The competitive landscape in the respiratory sector is evolving, with GSK being a leading player, and other companies like Roche and Sanofi also making significant moves [14][19]