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)。 智通财经APP讯，恒瑞医药(01276)公布，近日，公司子公司上海恒瑞医药有限公司、上海盛迪医药有限 公司收到国家药品监督管理局核准签发关于 SHR-7787 注射液、阿得贝利单抗注射液的《药物临床试验 批准通知书》，将于近期开展临床试验。 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 Durvaluma ...

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 ...

根据公告，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。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。 北京商报讯（记者 王寅浩 宋雨盈）1月21日，恒瑞医药发布公告称，公司子公司上海恒瑞医药有限公 司、上海盛迪医药有限公司收到国家药品监督管理局核准签发关于SHR-7787注射液、阿得贝利单抗注 射液的《药物临床试验批准通知书》，将于近期开展临床试验。 ...

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]

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]

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]

| 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 ...

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]

Core Viewpoint - Heng Rui Medicine announced that its subsidiaries, Shanghai Heng Rui Medicine and Shanghai Sheng Di Medicine, received clinical trial approval from the National Medical Products Administration for SHR-7787 injection and Adebali monoclonal antibody injection, with trials to commence shortly [1] Group 1: Clinical Trial Approvals - SHR-7787 injection is classified as a Class 1 therapeutic biological product, with a cumulative R&D investment of approximately 54.1 million yuan [1] - Adebali monoclonal antibody injection was approved for market launch in 2023, with a cumulative R&D investment of about 1.101 billion yuan [1] Group 2: R&D Challenges - The drug development and market launch cycle is lengthy and involves multiple stages, presenting uncertainties [1]

Policy Developments - The National Healthcare Security Administration has issued a guideline for the pricing of surgical and treatment auxiliary operations, focusing on medical technology innovations such as robotic surgery and 3D printing, establishing 37 pricing items and guiding the transition from traditional to precision medicine [2] Drug and Device Approvals - Bailitianheng's drug application for iza-bren, a first-in-class EGFR×HER3 dual antibody ADC for treating recurrent or metastatic esophageal squamous cell carcinoma, has been accepted and prioritized for review by the National Medical Products Administration [4] - Heng Rui Medicine has received clinical trial approval for SHR-9839, a humanized antibody for advanced solid tumors, and HRS-4642, a KRAS G12D inhibitor [5] - Fosun Pharma's subsidiary has been approved to conduct clinical trials for HLX701 in combination with chemotherapy for advanced colorectal cancer [6] Capital Market Activities - InnoCare Pharma has entered a collaboration agreement with Shenzhen Hengtai Biotechnology for the ISM8969 project, a new NLRP3 inhibitor for CNS diseases, with a potential total payment of up to $66 million [8][9] - Zhejiang Dejin Bio completed a multi-million A round financing to advance its core product, a recombinant botulinum toxin, and for international expansion [10] Industry Developments - Ant Group's Antifor has launched a DeepSearch feature on its PC platform to assist medical professionals with literature searches and clinical diagnosis [12] - Guangzhou's political advisor has proposed a plan to develop the brain-computer interface industry, aligning with national strategies and leveraging local resources [13] Shareholder Actions - Meihua Medical announced that shareholders plan to reduce their holdings by up to 2.51% of total shares due to personal financial needs [15] - Kain Technology has voluntarily withdrawn its drug registration application for a new hepatitis B indication, which will impact its 2025 profits [16]