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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]
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
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]
上证180指数上涨0.08%,上证180ETF指数基金(530280)实现4连涨
Sou Hu Cai Jing· 2026-01-21 01:55
Core Viewpoint - The Shanghai 180 ETF Index Fund closely tracks the Shanghai 180 Index, which reflects the overall performance of 180 large-cap and liquid stocks in the Shanghai securities market [2] Group 1: Index Performance - As of January 20, 2026, the Shanghai 180 Index rose by 0.08%, with notable increases in constituent stocks such as China Chemical (+10.01%), China Power Construction (+7.02%), and Hengli Petrochemical (+6.62%) [1] - The Shanghai 180 ETF Index Fund achieved a four-day consecutive increase, with the latest price reported at 1.26 yuan [1] - The fund's average daily trading volume over the past year was 256.26 million yuan, with a turnover rate of 0.11% on January 20, 2026 [1] Group 2: Fund Metrics - The fund's Sharpe ratio since inception is 2.13, indicating a favorable risk-adjusted return [1] - The maximum drawdown for the fund year-to-date is 1.30%, with a relative benchmark drawdown of 0.06% [1] - The management fee for the fund is 0.15%, and the custody fee is 0.05% [1] Group 3: Top Holdings - As of December 31, 2025, the top ten weighted stocks in the Shanghai 180 Index account for 25.29% of the index, including Kweichow Moutai, Zijin Mining, and China Ping An [2] - The top ten stocks by weight are Kweichow Moutai (4.21%), Zijin Mining (3.78%), and China Ping An (2.31%), among others [3]
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
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]
恒瑞医药(01276):注射用SHR-9839(sc)、HRS-4642注射液获药物临床试验批准
智通财经网· 2026-01-20 11:41
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: SHR-9839 - 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 [1] - The subcutaneous formulation of SHR-9839 has been developed, and there is currently one approved drug targeting the same pathway globally [1] Group 2: HRS-4642 - HRS-4642 is a KRAS G12D inhibitor developed by the company, formulated as a liposome injection [1] - HRS-4642 specifically binds to KRAS G12D and inhibits the phosphorylation of MEK and ERK proteins, demonstrating anti-tumor effects [1] - There are currently no similar drugs approved for HRS-4642 in both domestic and international markets [1]
恒瑞医药:注射用SHR-9839、HRS-4642注射液获药物临床试验批准
Zhi Tong Cai Jing· 2026-01-20 11:40
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: Drug Development - 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 [1] - The subcutaneous formulation of SHR-9839 has one competitor with the same target already approved globally [1] - HRS-4642 is a KRAS G12D inhibitor developed by the company, formulated as a liposome injection, which specifically binds to KRAS G12D and inhibits the phosphorylation of MEK and ERK proteins [1] - Currently, there are no similar drugs approved for HRS-4642 in both domestic and international markets [1]
恒瑞医药(01276.HK):注射用SHR-9839(sc)、HRS-4642注射液获临床试验批准
Ge Long Hui· 2026-01-20 11:37
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: SHR-9839 - 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 [1] - The subcutaneous formulation of SHR-9839 has one competitor with the same target already approved globally [1] - The total R&D investment for the SHR-9839 project has reached approximately 93.9 million yuan (unaudited) [1] Group 2: HRS-4642 - HRS-4642 is a KRASG12D inhibitor developed by the company, formulated as a liposome injection [1] - HRS-4642 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 the HRS-4642 project has reached approximately 254.2 million yuan (unaudited) [1]
2025年药品BD出海总结
Southwest Securities· 2026-01-20 11:37
Investment Rating - The report indicates a significant acceleration in BD (Business Development) overseas for Chinese innovative drugs, suggesting a positive investment outlook for the industry [3]. Core Insights - The number of BD projects, upfront payments, and total amounts for Chinese pharmaceutical companies significantly increased in 2025, with 165 projects, over $7.03 billion in upfront payments (up 226.8% year-on-year), and a total amount of $136.68 billion (up 192.2% year-on-year) [2][7]. - The report highlights a focus on dual antibodies (双抗), antibody-drug conjugates (ADC), GLP-1 receptor agonists (GLP1RA), and small nucleic acids as key areas for BD overseas [2][3]. Summary by Sections BD Project Growth - In 2025, the quarterly breakdown of BD projects shows 41, 43, 30, and 51 projects in Q1, Q2, Q3, and Q4 respectively, with significant year-on-year increases [2][7]. - Upfront payments for each quarter were $0.9 billion, $2.0 billion, $1.86 billion, and $2.27 billion, reflecting substantial growth rates [2][7]. Outbound BD Models - The predominant model for BD remains license in/out, while the NewCo/Co-CoJV model is gaining attention, with limited successful cases of independent commercialization [2][12][13]. - In 2025, MNCs (Multinational Corporations) accounted for $4.71 billion in upfront payments, representing 67% of total BD upfront payments [12]. Key Drug Categories - Dual antibodies saw a remarkable increase, with $3.5 billion in upfront payments (up 414.7%) and a total amount of $21.85 billion (up 361.5%) in 2025 [2][18]. - ADCs emerged as a significant focus, with $1.63 billion in upfront payments (up 676.2%) and a total amount of $21.13 billion (up 390.6%) [2][26]. - GLP-1RA projects achieved $470 million in upfront payments, marking a 109.8% increase, with a total amount of $9.6 billion [2]. NewCo Model - The NewCo model has facilitated overseas BD, with a total of $350 million in upfront payments and $13.74 billion in potential total amounts from 2023 to 2025 [17]. - In 2025, NewCo projects secured $110 million in upfront payments and $4.76 billion in potential total amounts [17]. Clinical Development Stages - Approximately 62% of molecules were in early clinical stages (pre-clinical to before Phase II) at the time of BD, indicating a trend towards early-stage licensing [8][9].
恒瑞医药(01276):HRS-2141片(Ⅰ)、(Ⅱ)获药物临床试验批准通知书
智通财经网· 2026-01-20 11:35
Core Viewpoint - Heng Rui Medicine (01276) announced that its subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of HRS-2141 tablets (I) and (II), which will commence shortly [1] Group 1 - HRS-2141 tablets (I) and (II) are fixed-dose combination formulations designed to synergistically lower blood glucose through complementary pharmacological mechanisms [1] - Currently, there are no similar drugs approved for marketing domestically or internationally [1] - As of the date of the announcement, the cumulative research and development investment for this drug project is approximately 5.4 million yuan (unaudited) [1]