HENGRUI PHARMA(01276)
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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
Zheng Quan Shi Bao Wang· 2026-01-21 08:46
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]
恒瑞医药:子公司两药品获药物临床试验批准通知书
Xin Lang Cai Jing· 2026-01-21 08:38
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]
智通AH统计|1月21日
智通财经网· 2026-01-21 08:18
Core Viewpoint - The report highlights the current premium rates of AH shares, with Northeast Electric, Zhejiang Shibao, and Junda Co. leading in premium rates, while CATL, Hengrui Medicine, and China Merchants Bank are at the bottom of the list [1][2]. Premium Rate Rankings - Northeast Electric (00042) has a premium rate of 815.25%, followed by Zhejiang Shibao (01057) at 378.67% and Junda Co. (02865) at 342.63% [2]. - The lowest premium rates are recorded for CATL (03750) at -13.79%, Hengrui Medicine (01276) at -2.52%, and China Merchants Bank (03968) at -2.22% [1][2]. Deviation Values - Junda Co. (02865) has the highest deviation value at 104.89%, followed by Goldwind Technology (02208) at 23.62% and Guanghetong (00638) at 20.17% [1][2]. - The lowest deviation values are for Northeast Electric (00042) at -35.64%, Chenming Paper (01812) at -16.87%, and China Life (02628) at -15.34% [1][4]. Additional Insights - The report includes a detailed table of the top ten and bottom ten AH stocks based on premium rates and deviation values, providing a comprehensive overview of the current market situation [2][3][4].
2025年度IPO报告,一行业退出回报2000亿
投中网· 2026-01-21 06:47
Core Findings - In 2025, a total of 170 Chinese companies with VC/PE backgrounds went public, marking a 27.82% increase from 133 in 2024, with a VC/PE penetration rate of 57.82% [10][7] - The electronic information sector reported an exit return of nearly 200 billion yuan, with the Hong Kong Stock Exchange's main board showing the highest exit returns [7][11] - A total of 294 Chinese companies successfully completed IPOs globally, with both the number of IPOs and the amount raised showing signs of recovery [20][23] VC/PE Investment Analysis - The scale of VC/PE exit returns reached 431.8 billion yuan in 2025, a 116% increase from 199.9 billion yuan in 2024, with an average return rate of 2.89 times [11][10] - The electronic information industry had the highest exit return at 182.81 billion yuan, while the consumer sector had the highest return multiple at 13.71 times [11][16] IPO Market Overview - In 2025, the total number of IPOs in A-shares, Hong Kong, and U.S. markets was 294, with a 29.52% year-on-year increase, and the total amount raised was 372.5 billion yuan, up 152% [20][23] - The Hong Kong Stock Exchange's main board led with 111 IPOs, while the Nasdaq Capital Market followed with 57 [23][38] Sector Performance - The electronic information sector led with 48 IPOs, followed by advanced manufacturing and healthcare with 47 and 41 IPOs, respectively [53][56] - The energy and mining sector raised the most funds at 784.38 billion yuan, while the average fundraising amount in the public utility sector surged by 6,935% [57][58] Regional Analysis - Jiangsu, Guangdong, and Hong Kong had the highest number of IPOs, with 46, 42, and 38 respectively, while Fujian led in fundraising with 571.78 billion yuan [59][64] - The number of IPOs in Inner Mongolia increased threefold, marking the highest growth rate [63][64] Notable IPOs - The top fundraising companies included Huadian New Energy, which raised over 100 billion yuan, and several electronic information companies like Moer Thread and Muxi Co., Ltd. [35][18]
21健讯Daily | 恒瑞医药:收到药物临床试验批准通知书;英矽智能:与衡泰生物达成超5亿港元合作
2 1 Shi Ji Jing Ji Bao Dao· 2026-01-21 04:10
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]
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
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2026-01-20 23:33
Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. has received clinical trial approval from the National Medical Products Administration for two drugs, SHR-9839 and HRS-4642, indicating progress in its oncology pipeline [1][2]. Group 1: Drug Information - SHR-9839 is a humanized antibody drug developed by the company, intended for the treatment of advanced solid tumors by blocking two key signaling pathways related to tumor development. The total R&D investment for SHR-9839 has reached approximately 93.9 million yuan (about 13.5 million USD) [1]. - HRS-4642 is a KRAS G12D inhibitor in a liposome formulation, specifically designed to bind to KRAS G12D and inhibit the phosphorylation of MEK and ERK proteins, with no similar drugs approved in the market. The cumulative R&D investment for HRS-4642 is approximately 254.2 million yuan (about 36.5 million USD) [2]. - HRS-2141 tablets (I) and (II) have also received clinical trial approval for type 2 diabetes treatment, with a cumulative R&D investment of about 5.4 million yuan (about 0.8 million USD) [6]. Group 2: Regulatory Approval - The company has received the clinical trial approval notice for SHR-9839 and HRS-4642, allowing it to proceed with clinical trials [1][2]. - The approval for HRS-2141 tablets was granted based on compliance with the relevant drug registration requirements, allowing the company to initiate clinical trials for the diabetes indication [6].
恒瑞医药(600276.SH):注射用SHR-9839(sc)、HRS-4642注射液药物临床试验获批
智通财经网· 2026-01-20 12:39
Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of SHR-9839 and HRS-4642, indicating progress in its oncology drug development pipeline [1] Group 1: Clinical Trials - The company and its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., will conduct clinical trials for SHR-9839 in advanced colorectal cancer patients, focusing on safety, tolerability, and efficacy [1] - The clinical study for SHR-9839 is an open-label, multicenter Phase I/II trial [1] Group 2: Drug Details - SHR-9839 is a humanized antibody drug developed by the company, aimed at treating advanced solid tumors by blocking two key signaling pathways related to tumor development [1] - The subcutaneous formulation of SHR-9839 has one competitor drug approved globally targeting the same pathway [1] - The total R&D investment for SHR-9839 to date is approximately 93.9 million yuan (unaudited) [1] Group 3: HRS-4642 Injection - HRS-4642 injection specifically binds to KRASG12D and inhibits the phosphorylation of MEK and ERK proteins, demonstrating anti-tumor effects [1] - Currently, there are no similar drugs approved for HRS-4642 in both domestic and international markets [1] - The total R&D investment for HRS-4642 to date is approximately 254.2 million yuan (unaudited) [1]