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恒瑞医药(01276):SHR-7787 注射液、SHR-4849 注射液、贝伐珠单抗注射液、阿得贝利单抗注射液获批开展临床试验
智通财经网· 2025-09-29 10:39
Core Insights - 恒瑞医药's subsidiaries have received approval from the National Medical Products Administration for clinical trials of four injectable drugs, including SHR-7787, SHR-4849, Bevacizumab, and Adebali monoclonal antibody [1][2] Group 1: SHR-7787 and SHR-4849 - SHR-7787 is a first-class therapeutic biological product that activates T cells to target and kill tumor cells, with no similar drugs approved in China to date. The total R&D investment for SHR-7787 is approximately 48.93 million yuan [1] - SHR-4849 is an antibody-drug conjugate targeting DLL3, designed to treat advanced malignant solid tumors, with no similar drugs approved in China or abroad. The total R&D investment for SHR-4849 is approximately 69.67 million yuan [1] Group 2: Bevacizumab and Adebali Monoclonal Antibody - Bevacizumab, a humanized anti-VEGF monoclonal antibody, was approved in the U.S. in 2004 and has generated global sales of approximately 5.655 billion USD in 2024. The total R&D investment for Bevacizumab by the company is approximately 348.89 million yuan [2] - Adebali monoclonal antibody is a humanized anti-PD-L1 monoclonal antibody approved in February 2023 for first-line treatment of extensive-stage small cell lung cancer. The total R&D investment for Adebali is approximately 939.08 million yuan, with similar products generating combined global sales of approximately 9.648 billion USD in 2024 [2]
恒瑞医药(01276.HK)子公司获SHR-7787注射液、SHR-4849注射液、贝伐珠单抗注射液、阿得贝利单抗注射液的药物临床试验批准通知书
Ge Long Hui· 2025-09-29 10:39
Core Viewpoint - Recently, Jiangsu Hengrui Medicine Co., Ltd. announced that its subsidiaries have received approval from the National Medical Products Administration for clinical trials of several injection drugs, indicating progress in their oncology drug development pipeline [1]. Group 1: Clinical Trial Approvals - Hengrui Medicine's subsidiaries, including Suzhou Sediya Biopharmaceutical Co., Ltd., Shanghai Hengrui Medicine Co., Ltd., and Shanghai Shengdi Medicine Co., Ltd., have received clinical trial approval notices for SHR-7787 injection, SHR-4849 injection, Bevacizumab injection, and Atezolizumab injection [1]. - The approved drugs will undergo clinical trials, with SHR-7787 injection being tested in a multicenter, open-label Phase II study in patients with malignant solid tumors [1]. Group 2: Regulatory Compliance - The approved drugs were reviewed and found to meet the requirements for drug registration as per the Drug Administration Law of the People's Republic of China, allowing for the commencement of clinical trials [1]. - The approval date for the drugs was noted as July 17, 2025, indicating a timeline for the regulatory process [1].
恒瑞医药子公司获国家药监局核准签发HRS-2129片的《药物临床试验批准通知书》
Zhi Tong Cai Jing· 2025-09-29 10:36
HRS-2129片拟用于治疗急慢性疼痛。经查询,目前国内尚无同靶点药物获批上市。截至目前,HRS- 2129片相关项目累计研发投入约为1.12亿元。 恒瑞医药(600276)(01276)发布公告,近日,公司子公司山东盛迪医药有限公司、上海恒瑞医药有限 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HRS-2129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)子公司获国家药监局核准签发HRS-2129片的《药物临床试验批准通知书》
智通财经网· 2025-09-29 10:33
HRS-2129 片拟用于治疗急慢性疼痛。经查询,目前国内尚无同靶点药物获批上市。截至目前,HRS- 2129片相关项目累计研发投入约为1.12亿元。 智通财经APP讯,恒瑞医药(01276)发布公告,近日,公司子公司山东盛迪医药有限公司、上海恒瑞医药 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HRS-2129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)子公司获HRS-2129片的药物临床试验批准通知书
Ge Long Hui· 2025-09-29 10:32
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS-2129 tablets, which are intended for the treatment of diabetic peripheral neuropathic pain and osteoarthritis pain in adults [1] Group 1: Drug Information - Drug Name: HRS-2129 tablets [1] - Dosage Form: Tablet [1] - Clinical Trial Acceptance Numbers: CXHL2500661, CXHL2500662, CXHL2500663, CXHL2500664 [1] - Approval Conclusion: The drug meets the requirements for drug registration and is approved for clinical trials [1] Group 2: Market Context - HRS-2129 tablets are aimed at treating acute and chronic pain [1] - Currently, there are no approved drugs targeting the same mechanism in the domestic market [1] - Cumulative R&D investment for HRS-2129 tablets is approximately 112 million yuan [1]
恒瑞医药SHR—7787注射液等药物临床试验获批
Bei Jing Shang Bao· 2025-09-29 09:49
Core Viewpoint - Heng Rui Medicine announced the approval of clinical trial notifications for four injectable drugs by the National Medical Products Administration, indicating a significant advancement in its oncology pipeline [1] Group 1: Clinical Trial Approvals - The company’s subsidiaries received approval for SHR-7787, SHR-4849, Bevacizumab, and Atezolizumab for clinical trials [1] - SHR-7787 is a first-class therapeutic biological product that activates T cells to target and kill tumor cells [1] - SHR-4849 is an antibody-drug conjugate targeting DLL3, designed to treat advanced malignant solid tumors by specifically binding to DLL3 antigens on tumor cells [1] Group 2: Drug Mechanisms - Bevacizumab is a humanized anti-VEGF monoclonal antibody, commonly used in cancer treatment [1] - Atezolizumab is a humanized anti-PD-L1 monoclonal antibody that blocks the PD-1/PD-L1 pathway, reactivating the immune system's anti-tumor activity [1]
恒瑞医药HRS—2129片药物临床试验获批
Bei Jing Shang Bao· 2025-09-29 09:49
北京商报讯(记者 王寅浩 实习记者 宋雨盈)9月29日,恒瑞医药发布公告称,公司子公司山东盛迪医 药有限公司、上海恒瑞医药有限公司收到国家药品监督管理局核准签发关于HRS—2129片的《药物临床 试验批准通知书》,同意开展成人糖尿病性周围神经病理性疼痛、成人骨关节炎疼痛适应症的临床试 验。 ...
恒瑞医药(600276) - H股公告-翌日披露报表
2025-09-29 09:15
FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) FF305 確認 根據《主板上市規則》第13.25C條 / 《GEM上市規則》第17.27C條,我們在此確認,據我們所知所信,第一章節所述的每項股份發行或庫存股份出售或轉讓已獲發行人董事會正式授權批准,並遵 照所有適用上市規則、法律及其他監管規定進行,並在適用的情況下: 表格類別: 股票 狀態: 新提交 公司名稱: 江蘇恒瑞醫藥股份有限公司 呈交日期: 2025年9月29日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司(「香港聯交所」)證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露,必須填妥第一章節 。 | 第一章節 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | A 股份類別 | | 於香港聯交所上市 | 否 | | | 證券代號 (如上市) | 600276 ...
恒瑞医药(01276)9月29日耗资约7370.23万元回购108万股A股
智通财经网· 2025-09-29 08:54
智通财经APP讯,恒瑞医药(01276)公布,2025年9月29日耗资约7370.23万元回购108万股A股股份。 ...
恒瑞医药9月29日耗资约7370.23万元回购108万股A股
Zhi Tong Cai Jing· 2025-09-29 08:54
恒瑞医药(600276)(01276)公布,2025年9月29日耗资约7370.23万元回购108万股A股股份。 ...