Core Viewpoint - Heng Rui Medicine (600276) has received a confirmation letter from the FDA regarding the acceptance of its biologics license application for injection of Carrelizumab combined with Apatinib for first-line treatment of unresectable or metastatic hepatocellular carcinoma patients [1] Group 1: Company Updates - The FDA has accepted the biologics license application for Carrelizumab, indicating progress in the company's drug development pipeline [1] - The total R&D investment for Carrelizumab-related projects has reached approximately 319.74 million yuan (unaudited) [1] Group 2: Industry Context - Several PD-1 monoclonal antibodies have been approved and are available in the market, including Pembrolizumab (Merck, brand name Keytruda), Nivolumab (Bristol-Myers Squibb, brand name Opdivo), Cemiplimab (Regeneron Pharmaceuticals, brand name Libtayo), and Dostarlimab (GlaxoSmithKline, brand name Jemperli) [1] - The global sales of anti-PD-1 antibodies are projected to reach approximately $41.546 billion in 2024 [1]

证券日报网讯2月3日，恒瑞医药（600276）在互动平台回答投资者提问时表示，公司坚持科技创新战 略，累计研发投入超500亿元，近三年每年研发投入占营收比重超过25%，将继续加强研发能力并优化 产品结构。 ...

（文章来源：证券日报） 证券日报网讯 2月3日，恒瑞医药在互动平台回答投资者提问时表示，公司日常经营管理和业务状况正 常，不存在按规定应披露而未披露的重大信息。公司董事会2025年8月20日审议通过新一期回购方案， 以自有资金回购公司A股股份，回购的股份拟用于A股员工持股计划，回购期限为自2025年8月20日董事 会审议通过回购股份方案之日起12个月以内，回购资金总额不低于人民币10亿元且不超过20亿元。截至 2026年1月底，本期回购已支付总金额达6.46亿元（不含交易费用），公司将在回购期限内根据市场情 况择机做出回购决策并予以实施，同时根据回购股份事项进展情况及时履行信息披露义务，后续进展请 关注公司于交易所网站上发布的相关公告。 ...

FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2026年1月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 江蘇恒瑞醫藥股份有限公司 呈交日期: 2026年2月3日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01276 | 說明 | H股 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 258,197,600 | RMB | | 1 | RMB | | 258,197,600 | | 增加 / 減少 (-) | | | | | | | RMB | | | | 本月底結存 | | | 258,197,600 | RMB | | 1 | RMB | | 258,197,600 | | 2. 股份分類 ...

FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2026年1月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 江蘇恒瑞醫藥股份有限公司 II. 已發行股份及/或庫存股份變動及足夠公眾持股量的確認 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01276 | 說明 | H股 | | | | | | | | 已發行股份（不包括庫存股份）數目 | | 庫存股份數目 | | 已發行股份總數 | | | 上月底結存 | | | 258,197,600 | | 0 | | 258,197,600 | | 增加 / 減少 (-) | | | 0 | | 0 | | | | 本月底結存 | | | 258,197,600 | | 0 | | 258,197,600 | 足夠公眾持股量的確認(註4) 呈交日期: 2026年2月3日 I. 法定/註冊股本變動 | 1. ...

Investment Rating - The industry investment rating is "Positive" (maintained) [6] Core Insights - The report highlights the significant commercial value of extrahepatic delivery technology for small nucleic acid drugs, which is expanding from liver diseases to multiple disease areas. Domestic companies are rapidly developing multi-target drugs and extrahepatic delivery platforms, which are expected to accelerate the release of potential clinical value [3][8] - The report emphasizes that multinational corporations (MNCs) are intensifying their focus on next-generation delivery platforms, moving from "liver validation" to "multi-organ expansion." This shift is crucial as it addresses unmet clinical needs in various tissues such as fat, muscle, central nervous system, heart, and kidneys [8] - The report indicates that 2026 is a pivotal year for small nucleic acid therapies, with domestic innovative drugs expected to become core assets for transactions. Domestic companies have accumulated rich experience in chemical modifications and liver-targeted delivery technologies, covering high-value areas such as hyperlipidemia, hypertension, hepatitis B, and weight loss [8] Summary by Sections Industry Overview - The report focuses on the pharmaceutical and biotechnology industry in China, specifically on small nucleic acid drugs and their evolving delivery technologies [5][6] Investment Recommendations and Targets - The report lists several investment targets, including: - YK Pharma (688658, Buy) - Hengrui Medicine (600276, Buy) - Xinda Biopharma (01801, Not Rated) - Other companies such as Chengdu XianDao (688222, Not Rated), Reborn Biotech (06938, Not Rated), and others [3]

Group 1 - The core viewpoint of the news highlights the positive performance of the medical innovation sector, with the CSI Medical and Medical Device Innovation Index showing mixed results among its constituent stocks, led by Aimeike with a 2.18% increase [1] - The Medical Innovation ETF has seen continuous net inflows over the past 12 days, with a peak single-day net inflow of 41.83 million yuan, totaling 234 million yuan, averaging 19.54 million yuan per day [1] - Policy support for the pharmaceutical industry is ongoing, with Shanghai accelerating the implementation of major industrial projects in fields such as integrated circuits, biomedicine, and artificial intelligence [1] Group 2 - The CSI Medical and Medical Device Innovation Index consists of 30 listed companies with good profitability, growth potential, and research innovation capabilities, reflecting the overall performance of profitable and growth-oriented pharmaceutical and medical device companies [2] - As of January 30, 2026, the top ten weighted stocks in the index include WuXi AppTec, Mindray Medical, and Heng Rui Medicine, accounting for 63.9% of the total index weight [2] - The success rate of Phase I clinical trials for dozens of AI-derived pipelines entering trials in 2025 is projected to be as high as 80%-90%, significantly exceeding traditional levels of 40%-65% [1]

Group 1 - The core announcement is that Jiangsu Hengrui Medicine Co., Ltd. has received a confirmation letter from the FDA regarding the acceptance of its Biologics License Application (BLA) for injection of Carrelizumab combined with Apatinib for first-line treatment of unresectable or metastatic hepatocellular carcinoma [1] - The target review date set by the FDA for the BLA is July 23, 2026, under the Prescription Drug User Fee Act (PDUFA) [1] - The drug Carrelizumab is a humanized anti-PD-1 monoclonal antibody that restores the body's anti-tumor immunity by blocking the PD-1/PD-L1 pathway [5] Group 2 - The clinical trial for Carrelizumab combined with Apatinib was approved in December 2018 and achieved orphan drug designation from the FDA in April 2021 [2] - The Phase III clinical trial (SHR-1210-III-310) demonstrated significant survival benefits, with a median progression-free survival (PFS) of 5.6 months and a median overall survival (OS) of 22.1 months, which was later updated to 23.8 months [3] - The study involved 543 participants and compared the efficacy and safety of Carrelizumab combined with Apatinib against Sorafenib, marking it as the first successful Phase III trial of immunotherapy combined with a small molecule tyrosine kinase inhibitor for advanced hepatocellular carcinoma [3] Group 3 - The total research and development investment for Carrelizumab has reached approximately 319.74 million yuan (unaudited) [5] - The global sales of anti-PD-1 antibodies are projected to be around 41.546 billion USD in 2024 [5] - The company plans to continue advancing the project and will fulfill its information disclosure obligations regarding subsequent developments [1]

江苏恒瑞医药股份有限公司 关于董事会延期换届的提示性公告 登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：600276 证券简称：恒瑞医药 公告编号：临2026-020 2026年2月2日 江苏恒瑞医药股份有限公司(以下简称"公司")第九届董事会已于 2026 年2月1日任期届满。鉴于公司新 一届董事会换届相关工作正在筹备中，为保证公司董事会相关工作的连续性和稳定性，公司董事会的换 届选举工作将适当延期，董事会各专门委员会、高级管理人员的任期亦相应顺延。 在新一届董事会换届选举工作完成前，公司第九届董事会全体董事、董事会各专门委员会成员及高级管 理人员将继续按照相关法律法规和《公司章程》等规定，履行董事及高级管理人员的职责和义务。 公司董事会换届延期不会影响公司的正常运营，公司正在积极推进，尽快完成董事会的换届选举工作， 并及时履行信息披露义务。 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性承担法律责任。 特此公告。 江苏恒瑞医药股份有限公司董事会 ...

Core Viewpoint - Jiangsu Hengrui Medicine Co., Ltd. has received a confirmation letter from the FDA regarding the acceptance of its Biologics License Application (BLA) for injection of Carrelizumab combined with Apatinib for first-line treatment of unresectable or metastatic hepatocellular carcinoma patients, with a target review date set for July 23, 2026 [1][2]. Group 1: Drug Information - Drug Name: Injection of Carrelizumab [1] - Dosage Form: Injection [1] - Applicant: Jiangsu Hengrui Medicine Co., Ltd. [1] - Indication: First-line treatment for unresectable or metastatic hepatocellular carcinoma in combination with Apatinib [1]. Group 2: Clinical Trial Information - The international multicenter Phase III clinical trial (Study No. SHR-1210-III-310) for Carrelizumab combined with Apatinib was approved in December 2018 [2]. - The trial demonstrated that Carrelizumab combined with Apatinib significantly extended progression-free survival (PFS) and overall survival (OS) compared to Sorafenib [2][3]. - The study enrolled 543 participants and showed a median PFS of 5.6 months and a median OS of 22.1 months, with the final analysis indicating an OS extension to 23.8 months [3]. Group 3: Market Context - Carrelizumab is a humanized anti-PD-1 monoclonal antibody that restores the body's anti-tumor immunity [5]. - The global sales of anti-PD-1 antibodies are projected to reach approximately $41.546 billion in 2024 [5]. - Cumulative R&D investment for Carrelizumab has reached approximately 319.74 million yuan (unaudited) [5].