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恒瑞医药:子公司HRS-5635注射液纳入拟突破性治疗品种公示名单
Xin Lang Cai Jing· 2025-09-17 08:38
Core Viewpoint - Heng Rui Medicine announced that its subsidiary, Fujian Shengdi Pharmaceutical Co., Ltd., has had its HRS-5635 injection included in the list of proposed breakthrough therapeutic products by the National Medical Products Administration, with a public announcement period of 7 days [1] Group 1 - HRS-5635 injection is a new generation liver-targeted HBV siRNA drug independently developed by the company [1] - The phase II clinical study results indicate that HRS-5635 has the potential to improve functional cure rates for chronic hepatitis B, while also demonstrating good safety characteristics [1]
恒瑞医药:注射用瑞康曲妥珠单抗新适应症上市许可申请获受理并纳入优先审评程序
Xin Lang Cai Jing· 2025-09-17 08:38
Core Viewpoint - Heng Rui Medicine announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., received a "Notice of Acceptance" from the National Medical Products Administration for the new indication application of SHR-A1811 (Injection of Rukang Qutuzumab) for the treatment of locally advanced or metastatic HER2-positive adult breast cancer patients who have previously received one or more anti-HER2 therapies. The application has been included in the priority review process [1] Group 1 - The application for SHR-A1811 has been accepted for a new indication [1] - The drug is intended for patients with locally advanced or metastatic HER2-positive breast cancer [1] - The application has been prioritized for review by the National Medical Products Administration [1]
中银晨会聚焦-20250917
Group 1: Key Insights on Macro Economy - In August, industrial added value and retail sales growth rates fell below expectations, with industrial added value growing by 5.2% year-on-year, and retail sales increasing by 3.4% year-on-year [6][8][9] - Fixed asset investment growth for January to August was only 0.5%, with private investment declining by 2.3% [7][9] - The report highlights the need for macro policies to stabilize growth, particularly in light of external uncertainties and domestic climate factors [6][9] Group 2: Real Estate Industry Analysis - In August, new home prices in 70 major cities fell by 0.3% month-on-month, while second-hand home prices decreased by 0.6% [10][11] - The sales area for residential properties in August was 57.44 million square meters, down 10.6% year-on-year, marking the lowest level since 2009 [17][18] - Real estate development investment in August was 672.9 billion yuan, a year-on-year decline of 19.5%, with new construction area down 20.3% [17][20] Group 3: Transportation Sector Insights - SF Holding reported a revenue of 146.858 billion yuan for the first half of 2025, a year-on-year increase of 9.26%, with net profit rising by 19.37% [25][26] - The company’s express logistics segment grew by 10.4%, while supply chain and international segments increased by 9.7% [27]
恒瑞医药:注射用SHR-1826、阿得贝利单抗注射液、贝伐珠单抗注射液获得药物临床试验批准通知书
Zhi Tong Cai Jing· 2025-09-16 14:34
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of three injectable drugs, indicating progress in its oncology pipeline [1] Group 1: Clinical Trial Approvals - The company's subsidiaries, Suzhou Shengdiya Biopharmaceutical Co., Ltd. and Shanghai Shengdi Medicine Co., Ltd., have been granted clinical trial approval for SHR-1826, Adebali monoclonal antibody injection, and Bevacizumab injection [1] - SHR-1826 is an antibody-drug conjugate targeting c-MET, designed to selectively bind to tumor cell surface antigens and induce cell death [1] - Adebali monoclonal antibody injection, a humanized anti-PD-L1 monoclonal antibody, aims to block the PD-1/PD-L1 pathway, reactivating the immune system's anti-tumor activity [1] Group 2: Product Development and Market Status - Adebali monoclonal antibody injection (brand name: Ailili) was approved for market in March 2023 for first-line treatment of extensive-stage small cell lung cancer in combination with carboplatin and etoposide [1] - Bevacizumab, a humanized anti-VEGF monoclonal antibody, was co-developed by domestic and foreign pharmaceutical companies and has been marketed since 2004 in the U.S. under the brand name Avastin [1] - The company's Bevacizumab injection was approved for market in June 2021, with multiple formulations currently available in China and globally [1]
恒瑞医药(01276):注射用SHR-1826、阿得贝利单抗注射液、贝伐珠单抗注射液获得药物临床试验批准通知书
智通财经网· 2025-09-16 14:33
Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of three injectable drugs, indicating progress in its oncology pipeline [1] Group 1: Drug Approvals - The company's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., and Shanghai Shengdi Pharmaceutical Co., Ltd. have received clinical trial approval for SHR-1826, Adebali monoclonal antibody injection, and Bevacizumab injection [1] - SHR-1826 is an antibody-drug conjugate targeting c-MET, designed to selectively bind to tumor cell surface antigens and induce cell death [1] - Adebali monoclonal antibody injection, a humanized anti-PD-L1 monoclonal antibody, aims to block the PD-1/PD-L1 pathway, reactivating the immune system's anti-tumor activity [1] - Adebali monoclonal antibody injection (brand name: Ailili) was approved for market in March 2023 for first-line treatment of extensive-stage small cell lung cancer in combination with carboplatin and etoposide [1] - Bevacizumab is a humanized anti-VEGF monoclonal antibody, co-developed by Genentech and a Chinese pharmaceutical company, and has been marketed globally since its approval in the U.S. in 2004 [1] - The company's Bevacizumab injection was approved for market in June 2021, with multiple formulations currently available in China [1]
恒瑞医药制定2025 年 A 股员工持股计划
Zhi Tong Cai Jing· 2025-09-16 14:23
Core Viewpoint - Heng Rui Medicine (600276) has announced a 2025 A-share employee stock ownership plan aimed at establishing a profit-sharing mechanism among the company, shareholders, and employees to enhance employee motivation, creativity, cohesion, and overall competitiveness, thereby promoting the company's long-term and sustainable development [1] Summary by Relevant Sections - The employee stock ownership plan involves the repurchase of up to 14 million A-shares, accounting for approximately 0.21% of the company's total share capital as of the announcement date [1] - The repurchase price is set at 30.95 yuan per share, with the final number of shares held under the plan to be determined based on actual execution [1] - The total number of employees participating in the plan is expected to be no more than 1,316 (excluding reserved shares), with a maximum of 9 individuals from the board (excluding independent directors), supervisors, and senior management [1]
恒瑞医药(01276)制定2025 年 A 股员工持股计划
智通财经网· 2025-09-16 14:22
Core Viewpoint - Heng Rui Medicine (01276) has announced a 2025 A-share employee stock ownership plan aimed at establishing a profit-sharing mechanism among the company, shareholders, and employees to enhance employee motivation, creativity, cohesion, and overall company competitiveness, promoting long-term and sustainable development [1] Summary by Relevant Sections - Employee Stock Ownership Plan Details - The plan involves the acquisition of up to 14 million A-shares (including reserved shares), accounting for approximately 0.21% of the company's total share capital as of the announcement date [1] - The acquisition price is set at 30.95 yuan per share, with the final number of shares held under the plan to be determined based on actual execution [1] - Participation and Eligibility - The total number of employees participating in the plan is expected to be no more than 1,316 (excluding reserved shares) [1] - Among the participants, the number of company directors (excluding independent directors), supervisors, and senior management is limited to no more than 9 (excluding reserved shares), with the final number of participants and subscription details to be confirmed based on actual employee contributions [1]
潜在交易额近80亿,东南大学器官芯片技术助力创新药物研发
Yang Zi Wan Bao Wang· 2025-09-16 10:57
Core Insights - The innovative drug HRS-1893 has achieved a significant breakthrough with a licensing agreement between Heng Rui Medicine and Braveheart Bio, with a potential total transaction value of nearly 8 billion RMB [1][5] - The collaboration highlights the international recognition of China's innovative drug research and the focus on Southeast University's organ-on-a-chip technology [1][5] Group 1: Drug Development and Mechanism - HRS-1893 is designed to treat obstructive hypertrophic cardiomyopathy and functions as a selective inhibitor of cardiac myosin [3] - The drug's development involved collaboration with Professor Gu Zhongze's team at Southeast University, utilizing organ-on-a-chip technology for cell activity screening [3][7] Group 2: Clinical Trials and Licensing Agreement - HRS-1893 received approval for clinical trials in May 2023, marking it as the first new drug in China to use organ-on-a-chip data for such approval [5] - Braveheart Bio will have exclusive rights to develop, produce, and commercialize HRS-1893 globally, excluding certain regions in China, with Heng Rui Medicine set to receive an upfront payment of $7.5 million and potential milestone payments totaling up to $1.013 billion [5][8] Group 3: Technological Advancements and Future Plans - The organ-on-a-chip team at Southeast University has made significant advancements in key technologies over the past decade, achieving breakthroughs in high-precision 3D printing and functional biomaterials [7] - Future plans include further technological innovation and collaboration with more pharmaceutical companies to create new pathways for drug development and precision medicine [8]
恒瑞医药(600276) - 恒瑞医药2025年A股员工持股计划
2025-09-16 10:31
证券简称:恒瑞医药 证券代码:600276 江苏恒瑞医药股份有限公司 2025 年 A 股员工持股计划 2025 年 9 月 声明 本公司及全体董事保证本员工持股计划及其摘要不存在虚假记载、误导性陈 述或重大遗漏,并对其真实性、准确性、完整性承担个别和连带的法律责任。 1 特别提示 本部分内容中的词语简称与"释义"部分保持一致。 1、《江苏恒瑞医药股份有限公司 2025 年 A 股员工持股计划》系江苏恒瑞医 药股份有限公司依据《中华人民共和国公司法》《中华人民共和国证券法》《关 于上市公司实施员工持股计划试点的指导意见》《上海证券交易所上市公司自律 监管指引第 1 号——规范运作》等法律、行政法规、规章、规范性文件以及《江 苏恒瑞医药股份有限公司章程》的有关规定制定。 2、本员工持股计划遵循依法合规、自愿参与、风险自担的原则,不存在摊 派、强行分配等强制员工参加本员工持股计划的情形。 3、本员工持股计划的参加对象为公司董事(不含独立董事)、监事、高级 管理人员、公司及控股子公司核心管理人员、骨干员工和公司董事会认为应当激 励的其他员工。本员工持股计划的参加对象总人数不超过 1316 人(不含预留份 额),其中 ...
恒瑞医药(600276) - 恒瑞医药关于获得药物临床试验批准通知书的公告
2025-09-16 10:31
证券代码:600276 证券简称:恒瑞医药 公告编号:临 2025-144 江苏恒瑞医药股份有限公司 关于获得药物临床试验批准通知书的公告 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")子公司苏州盛迪亚 生物医药有限公司、上海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")核准签发关于注射用 SHR-1826、阿得贝利单抗注射液、贝伐 珠单抗注射液的《药物临床试验批准通知书》,将于近期开展临床试验。现将相 关情况公告如下: 野生型的晚期/转移性非鳞状非小细胞肺癌成人患者。截至目前,注射用 SHR-1826 相关项目累计研发投入约 8,809 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 ...