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恒瑞医药: SHR-7787 注射液、阿得贝利单抗注射液获批开展临床试验
Zhi Tong Cai Jing· 2026-01-21 11:31
Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of SHR-7787 injection and Adebeli monoclonal antibody injection, indicating progress in its oncology pipeline [1][2] Group 1: SHR-7787 Injection - SHR-7787 injection is a Class 1 therapeutic biological product designed to activate T cells to target and kill tumor cells [1] - The total research and development investment for SHR-7787 injection has reached approximately 54.1 million yuan (unaudited) [1] Group 2: Adebeli Monoclonal Antibody Injection - Adebeli monoclonal antibody injection is a humanized anti-PD-L1 monoclonal antibody that reactivates the immune system's anti-tumor activity by blocking the PD-1/PD-L1 pathway [2] - The product was approved for market in 2023 for first-line treatment of extensive-stage small cell lung cancer in combination with carboplatin and etoposide [2] - Global sales of similar products Atezolizumab, Avelumab, and Durvalumab are projected to total approximately 9.648 billion USD in 2024 [2] - The total research and development investment for Adebeli monoclonal antibody injection has reached approximately 1.101 billion yuan (unaudited) [2]
恒瑞医药(01276.HK):SHR-7787注射液、阿得贝利单抗注射液获得药物临床试验批准
Ge Long Hui· 2026-01-21 11:27
Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of SHR-7787 injection and Adebali monoclonal antibody injection, indicating progress in its oncology pipeline [1][2] Group 1: SHR-7787 Injection - SHR-7787 injection is a Class 1 therapeutic biological product that activates T cells to target and kill tumor cells [1] - The total R&D investment for SHR-7787 injection has reached approximately 54.1 million yuan (unaudited) [1] Group 2: Adebali Monoclonal Antibody Injection - Adebali monoclonal antibody injection is a humanized anti-PD-L1 monoclonal antibody that reactivates the immune system's anti-tumor activity by blocking the PD-1/PD-L1 pathway [2] - The injection was approved for market in 2023 for first-line treatment of extensive-stage small cell lung cancer in combination with carboplatin and etoposide [2] - The total R&D investment for Adebali monoclonal antibody injection has reached approximately 1.101 billion yuan (unaudited) [2] - Global sales of similar products Atezolizumab, Avelumab, and Durvalumab are projected to total approximately 9.648 billion USD in 2024 [2]
恒瑞医药(01276): SHR-7787 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· 2026-01-21 11:27
Group 1 - Company subsidiary Shanghai Hengrui Medicine Co., Ltd. and Shanghai Shengdi Medicine Co., Ltd. received approval from the National Medical Products Administration for clinical trials of SHR-7787 injection and Adebeli monoclonal antibody injection [1] - SHR-7787 injection is a Class 1 therapeutic biological product that activates T cells to target and kill tumor cells, with a cumulative R&D investment of approximately 54.1 million yuan (unaudited) [1] Group 2 - Adebeli monoclonal antibody injection is a humanized anti-PD-L1 monoclonal antibody that blocks the PD-1/PD-L1 pathway to reactivate the immune system's anti-tumor activity, approved for first-line treatment of extensive-stage small cell lung cancer in combination with carboplatin and etoposide [2] - The global sales of similar products Atezolizumab, Avelumab, and Durvalumab are projected to reach approximately 9.648 billion USD in 2024, with Atezolizumab and Durvalumab already approved for sale in China [2] - The cumulative R&D investment for Adebeli monoclonal antibody injection is approximately 1.101 billion yuan (unaudited) [2]
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
2026-01-21 11:22
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。 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 2026年1月21日 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 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 2026-01 ...
恒瑞医药两款药品临床试验获批
Bei Jing Shang Bao· 2026-01-21 10:41
Core Viewpoint - Heng Rui Medicine announced that its subsidiaries have received approval from the National Medical Products Administration for clinical trials of SHR-7787 injection and Adebeli monoclonal antibody injection, which will commence shortly [1] Group 1: Product Details - SHR-7787 injection is a Class 1 therapeutic biological product that activates T cells to target and kill tumor cells [1] - Adebeli monoclonal antibody injection is a humanized anti-PD-L1 monoclonal antibody developed by the company, which blocks the PD-1/PD-L1 pathway to reactivate the immune system's anti-tumor activity [1]
1月21日晚间重要公告一览
Xi Niu Cai Jing· 2026-01-21 10:30
Group 1: Profit Forecasts - Limin Co. expects a net profit of 465 million to 500 million yuan for 2025, representing a year-on-year increase of 471.55% to 514.57% [1] - Guohui Energy anticipates a net profit of 1.32 billion to 1.47 billion yuan for 2025, reflecting a decline of 50.03% to 55.13% year-on-year [2] - Jiajia Yue forecasts a net profit of 198 million to 228 million yuan for 2025, indicating a growth of 50.06% to 72.79% year-on-year [3] - Xianghe Industry projects a net profit of 120 million to 148 million yuan for 2025, with an expected increase of 59.17% to 96.31% year-on-year [4] - Aojie Technology predicts a net profit of 90 million to 120 million yuan for 2025, showing a growth of 228.34% to 337.79% year-on-year [14] - Shanghai Electric expects a net profit of 1.1 billion to 1.32 billion yuan for 2025, representing an increase of approximately 47% to 76% year-on-year [15] - Tianfu Communication anticipates a net profit of 1.881 billion to 2.15 billion yuan for 2025, reflecting a growth of 40% to 60% year-on-year [16] - Yichang Technology forecasts a net profit of 150 million to 225 million yuan for 2025, indicating a year-on-year increase of 58% to 138% [29] - Shanghai Yizhong expects a net profit of 60 million to 70 million yuan for 2025, representing a significant increase of 760.18% to 903.54% year-on-year [41] Group 2: Loss Forecasts - Kexin Electromechanical anticipates a net profit of 55 million to 70 million yuan for 2025, reflecting a decline of 58.65% to 67.51% year-on-year [11][12] - Kexin Technology expects a net loss of 900 million to 1.2 billion yuan for 2025, which is an increase in loss of 78.67% to 84% year-on-year [10] - Tianyang New Materials forecasts a net loss of 250 million to 180 million yuan for 2025, compared to a loss of 213 million yuan in the previous year [20] - Bo Rui Data anticipates a net loss of 90 million to 100 million yuan for 2025, which is an increase in loss of 15.17 million to 25.17 million yuan year-on-year [19] - Xinlian Integrated expects a net loss of 577 million yuan for 2025, which is a reduction in loss of approximately 40.02% compared to the previous year [40] - Fangshilong forecasts a net loss of 4 million to 6 million yuan for 2025 [30] Group 3: Strategic Developments - Lianlong signed a strategic framework agreement with Runyinglian to enhance the reliability and efficiency of the lubricant additive supply chain in China and the Asia-Pacific region [7] - Han Jian Heshan is planning to acquire a 52.51% stake in Liaoning Xingfu New Materials Co., Ltd., with stock suspension expected for up to 9 trading days [13] - Kai Zhong Precision plans to invest 116 million yuan in a technical transformation and expansion project to meet future capacity demands [34] - Tianfu Communication is expected to engage in clinical trials for its ABA001 injection, which has received approval from the National Medical Products Administration [17]
恒瑞医药:SHR-7787注射液、阿得贝利单抗注射液获得药物临床试验批准
Zhi Tong Cai Jing· 2026-01-21 09:22
Group 1 - Company subsidiary Shanghai Hengrui Medicine Co., Ltd. and Shanghai Shengdi Medicine Co., Ltd. received approval from the National Medical Products Administration for clinical trials of SHR-7787 injection and Adebali monoclonal antibody injection [1] - SHR-7787 injection is a Class 1 therapeutic biological product that activates T cells to target and kill tumor cells, with a cumulative R&D investment of approximately 54.1 million yuan (unaudited) [1] - Adebali monoclonal antibody injection is a humanized anti-PD-L1 monoclonal antibody that reactivates the immune system's anti-tumor activity, with a cumulative R&D investment of approximately 1.101 billion yuan (unaudited) [2] Group 2 - Adebali monoclonal antibody injection was approved for use in combination with carboplatin and etoposide for first-line treatment of extensive-stage small cell lung cancer patients in 2023 [2] - Similar products such as Atezolizumab, Avelumab, and Durvalumab have been approved for sale in the U.S., with Atezolizumab and Durvalumab also approved in China, and the global sales of these products are projected to total approximately 9.648 billion USD in 2024 [2]
恒瑞医药(600276.SH):SHR-7787注射液、阿得贝利单抗注射液获得药物临床试验批准
智通财经网· 2026-01-21 09:20
Group 1 - Company subsidiary Shanghai Hengrui Medicine Co., Ltd. and Shanghai Shengdi Medicine Co., Ltd. received approval from the National Medical Products Administration for clinical trials of SHR-7787 injection and Adebali monoclonal antibody injection [1] - SHR-7787 injection is a Class 1 therapeutic biological product that activates T cells to target and kill tumor cells, with a cumulative R&D investment of approximately 54.1 million yuan (unaudited) [1] - Adebali monoclonal antibody injection is a humanized anti-PD-L1 monoclonal antibody that reactivates the immune system's anti-tumor activity, with a cumulative R&D investment of approximately 1.101 billion yuan (unaudited) [2] Group 2 - Adebali monoclonal antibody injection was approved for marketing in 2023 for first-line treatment of extensive-stage small cell lung cancer in combination with carboplatin and etoposide [2] - Similar products such as Atezolizumab, Avelumab, and Durvalumab have been approved for sale in the U.S., with a combined global sales of approximately 9.648 billion USD in 2024 [2] - Atezolizumab and Durvalumab have also been approved for sale in China, indicating a competitive landscape for the company’s products [2]
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
2026-01-21 09:00
| 药品名称 | SHR-7787 注射液 | 阿得贝利单抗注射液 | | --- | --- | --- | | 剂型 | 注射剂 | | | 申请事项 | 临床试验 | | | 受理号 | CXSL2500896 | CXSL2500895 | | | 根据《中华人民共和国药品管理法》及有关规定,经审查, | | | 审批结论 | 2025 年 10 月 16 日受理的 SHR-7787 | 注射液、阿得贝利单抗注射 | | | 液符合药品注册的有关要求,同意开展临床试验。 | | 一、药品的基本情况 二、药品的其他情况 SHR-7787 注射液为 1 类治疗用生物制品,通过诱导激活 T 细胞,使其发挥 靶向杀伤肿瘤细胞的作用。截至目前,SHR-7787 注射液相关项目累计研发投入 约为 5,410 万元(未经审计)。 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 已于 2023 年获批上市,获批的适应症为与卡铂和 ...
恒瑞医药:SHR-7787注射液、阿得贝利单抗注射液获得药物临床试验批准通知书
Core Viewpoint - Heng Rui Medicine (600276) announced the approval of clinical trial applications for SHR-7787 injection and Adebeli monoclonal antibody injection by the National Medical Products Administration, indicating a significant step in the company's drug development pipeline [1] Group 1 - The company’s subsidiary, Shanghai Heng Rui Medicine Co., Ltd., received approval for clinical trials [1] - Another subsidiary, Shanghai Shengdi Medicine Co., Ltd., also received approval for clinical trials [1] - The clinical trials for both drugs are set to commence in the near future [1]