FF305 翌日披露報表 (股份發行人 ── 已發行股份或庫存股份變動、股份購回及/或在場内出售庫存股份) 表格類別： 股票 狀態： 新提交 公司名稱： 江蘇恒瑞醫藥股份有限公司 呈交日期： 2026年1月30日 如上市發行人的已發行股份或庫存股份出現變動而須根據《香港聯合交易所有限公司（「香港聯交所」）證券上市規則》(「《主板上市規則》」)第13.25A條 / 《香港聯合交易所有限公司GEM證券 上市規則》(「《GEM上市規則》」)第17.27A條作出披露，必須填妥第一章節 。 | 第一章節 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | 1. 股份分類 | 普通股 | 股份類別 A | | 於香港聯交所上市 | 否 | | | 證券代號 (如上市) | 600276 | 說明 | A股（於上海證券交易所上市） | | | | | A. 已發行股份或庫存股份變動 | | | | | | | | | | 已發行股份（不包括庫存股份）變動 | | 庫存股份變動 | | | | | 事件 | 已發行股份（不包括庫存股份）數 目 | 佔有關事件 ...

Group 1 - The pharmaceutical sector experienced a pullback, with the pharmaceutical ETF (159929) declining by 1.53% and a trading volume exceeding 1.3 billion yuan, indicating a net inflow of over 45 million yuan during the day, marking 11 consecutive days of capital inflow totaling over 360 million yuan [1][3] - Major stocks within the pharmaceutical ETF saw most decline, including Meien Health and Pianzaihuang dropping over 3%, WuXi AppTec and Aier Eye Hospital falling over 2%, while Tigermed rose over 7% [3][4] - Tigermed is projected to see a net profit growth of 105% to 204% by 2025, indicating strong future performance [3] Group 2 - The JPM 2026 conference highlighted a shift in the global pharmaceutical industry's focus towards the effective allocation and long-term value realization of innovations amidst rising uncertainties [5] - Chinese innovation is gaining global recognition, with increased participation from Chinese companies at the JPM 2026, reflecting a growing acknowledgment from international capital and multinational pharmaceutical companies [5][6] - The evaluation logic of multinational pharmaceutical companies regarding Chinese innovative assets is evolving, focusing on their efficacy, differentiation, and competitive positioning for inclusion in global product portfolios [6][10] Group 3 - Multinational pharmaceutical companies are entering a critical patent cliff period, necessitating diversification in their pipelines to mitigate risks associated with single products and treatment areas [10][12] - The integration of AI into core strategies is becoming mainstream, with AI being utilized to enhance R&D efficiency and optimize operational systems, thus addressing challenges posed by the patent cliff [12][13] - The oncology sector remains a core area for pharmaceutical innovation, with a focus on antibody-drug conjugates (ADCs) and cell therapies, indicating a robust pipeline and commercial potential [13][15]

Core Insights - The Chinese generic drug industry is undergoing significant changes due to policy factors, including the implementation of the drug marketing authorization holder system and early resolution mechanisms for patent disputes, which are reshaping the competitive landscape [1][11]. Industry Overview - The number of generic drug products that have passed or are deemed to have passed evaluations in China reached 2,998 in 2024, an increase of 1,008 from 2023, representing a year-on-year growth of 50.65% [1][11]. - The proportion of contract manufacturing among these evaluated generic drug products reached 33% in 2024, up from 12% in 2020, indicating a trend towards deeper industry collaboration and resource allocation [1][11]. Generic Drug Consistency Evaluation - The consistency evaluation of generic drugs ensures that they meet the same quality and efficacy standards as original drugs, which is crucial for patient safety and effective treatment [2][3]. - The evaluation process includes determining reference formulations, conducting pharmaceutical research, and ongoing monitoring to ensure compliance with quality and safety standards [2][3]. Industry Policies - Recent policies have been introduced to enhance the quality of generic drugs and promote their market acceptance, including the 2025 guidelines for deepening drug regulation reforms [5][6]. - The establishment of a reference formulation directory is essential for conducting consistency evaluations, with 87 batches published by the National Medical Products Administration by the end of 2024 [9]. Market Dynamics - The market for chemical generic drugs in China is projected to be 868.3 billion yuan in 2024, showing a decline of 3% year-on-year, with the market share of chemical generics in the overall drug market decreasing from 60% in 2018 to 50% in 2024 [7][8]. - The competitive landscape is becoming increasingly polarized, with leading pharmaceutical companies gaining significant market share while smaller firms face challenges due to funding and research limitations [11]. Key Companies - Notable companies in the generic drug consistency evaluation sector include Tigermed Pharmaceutical Technology Co., Ltd., Huahai Pharmaceutical Co., Ltd., and Hengrui Medicine Co., Ltd., among others [1][11]. - Tigermed reported a revenue of 1.71 billion yuan in clinical trial services for the first half of 2025, reflecting a 3.07% increase year-on-year, while Hengrui Medicine achieved a revenue of 13.693 billion yuan, up 12.85% [12][14]. Future Trends - The focus of generic drug evaluations is expected to shift towards high-tech barrier products, such as controlled-release formulations and complex injectables, requiring enhanced reverse engineering and pharmaceutical research capabilities [15][16]. - The production model is transitioning from batch production to continuous manufacturing, which aims to ensure consistent quality and compliance with evaluation standards [15][16]. - Companies are encouraged to adopt a full lifecycle management approach for their products, emphasizing ongoing research and optimization post-evaluation to maintain market leadership [16].

Policy Developments - The National Healthcare Security Administration and the National Administration of Traditional Chinese Medicine announced the inclusion of Beijing and other regions in a pilot program for disease-based payment for traditional Chinese medicine [2] Drug and Device Approvals - Heng Rui Medicine received acceptance for a new indication application for its innovative drug, injection of Carrelizumab combined with Apatinib, for the treatment of unresectable hepatocellular carcinoma [4] - Lifesun Pharmaceutical announced that its Aminophylline tablets passed the consistency evaluation for generic drugs, which is expected to enhance market competitiveness [5] - Eli Lilly's Metabolically Associated Fatty Liver Disease indication for Tirzepatide has been included in the list of breakthrough therapies by the National Medical Products Administration [6] Financial Reports - Yiming Pharmaceutical projected a net profit increase of 61.12% to 122.08% for 2025, driven by the growth of its core product, Miglitol tablets [8] - Innovation Medical forecasted a net loss of 26 million to 33 million yuan for 2025, primarily due to tax expenses and adjustments in healthcare policies [9] Capital Markets - Kangchen Pharmaceutical upgraded its share repurchase plan to a total of 300 million Hong Kong dollars, extending the buyback period until the next annual general meeting [11] Industry Developments - Huawei Cloud is set to launch a smart healthcare section as part of its AI "Dream Factory" initiative, aiming to integrate top medical resources and advanced technology [14] - AstraZeneca announced plans to invest 15 billion USD in China by 2030 to expand research and production capabilities [16]

Group 1 - Kangfang Biotech's AK112 has been proposed for inclusion as a breakthrough therapy for advanced biliary cancer, marking the fifth time it has received such recognition from CDE, offering new hope for patients with poor prognosis [1] - Hengrui Medicine has submitted new indication applications for its drugs, demonstrating the trend of integrating systemic and local treatments in solid tumor therapy, particularly in liver cancer [2] - Innovent Biologics expects a revenue increase of approximately 134% in 2025, projecting around 2.37 billion yuan, with a turnaround to a net profit of about 630 million yuan, driven by sustained commercialization and global business development [3] Group 2 - Roche's 2025 financial report indicates total revenue of approximately 74.37 billion USD, with pharmaceutical business revenue reaching about 57.63 billion USD, reflecting a 9% year-on-year growth [4] - Fosun Pharma has secured commercialization rights for VGX-3100, a therapeutic DNA drug targeting HPV, which is expected to complement existing preventive vaccines and address a significant market for infected individuals [5]

恒瑞医药获得药物临床试验批准通知书公告要点核心要点 一、获批情况 子公司山东盛迪医药收到HRS-7535片《药物临床试验批准通知书》 获批开展Ⅲ期临床试验，适应症为慢性肾脏病治疗 二、药物特点 三、研发投入 截至目前累计研发投入约3.69亿元（未经审计） 四、风险提示 新型口服小分子GLP-1R激动剂，全球尚无同类口服药物上市 作用机制：促进胰岛素分泌、降低胰高血糖素、抑制胃排空、增强饱腹感 临床前数据显示可显著改善动物慢性肾脏病症状 仍需完成临床试验及国家药监局审评审批后方可上市 研发周期长、环节多，存在不确定性 风险提示及免责条款 市场有风险，投资需谨慎。本文不构成个人投资建议，也未考虑到个别用户特殊的投资目标、财务状况 或需要。用户应考虑本文中的任何意见、观点或结论是否符合其特定状况。据此投资，责任自负。 恒瑞医药获得药物临床试验批准通知书公告要点核心要点 二、药物特点 新型口服小分子GLP-1R激动剂，全球尚无同类口服药物上市 作用机制：促进胰岛素分泌、降低胰高血糖素、抑制胃排空、增强饱腹感 临床前数据显示可显著改善动物慢性肾脏病症状 三、研发投入 截至目前累计研发投入约3.69亿元（未经审计） 一、 ...

Earnings Forecasts - Shengyi Electronics expects a net profit of 1.431 billion to 1.513 billion yuan in 2025, an increase of 331.03% to 355.88% year-on-year [1] - Tigermed anticipates a net profit of 830 million to 1.23 billion yuan in 2025, representing a growth of 105% to 204% year-on-year [2] - Shunbo Alloy forecasts a net profit of 210 million to 270 million yuan in 2025, with an increase of 222.96% to 315.23% year-on-year [3] - Jinkong Electric expects a net profit of 155 million to 195 million yuan in 2025, reflecting a growth of 383.21% to 507.9% year-on-year [9] - Baiao Saitu anticipates a net profit of 162 million to 182 million yuan in 2025, with a year-on-year increase of 384.26% to 443.88% [18] - Panjiang Co. expects a net profit of 318 million to 380 million yuan in 2025, representing a growth of 205.30% to 264.83% year-on-year [38] Loss Forecasts - Liaoning Energy predicts a net loss of 273 million to 410 million yuan in 2025, compared to a profit of 202 million yuan in the previous year [5] - Anbotong anticipates a net loss of 114 million to 165 million yuan in 2025, with a revenue decrease of 19.65% to 27.25% [7] - Wantai Bio forecasts a net loss of 330 million to 410 million yuan in 2025, compared to a profit of 106 million yuan in the previous year [12] - Xingyun Co. expects a net loss of 155 million to 230 million yuan in 2025, compared to a loss of 82.44 million yuan in the previous year [20] - Huaxing Co. anticipates a net loss of 800 million to 1.2 billion yuan in 2025, with a reduction in loss compared to 1.67 billion yuan in the previous year [46] New Product Approvals - Hengrui Medicine received acceptance for a new indication application for its innovative drug, combining Carrelizumab and Apatinib for treating unresectable liver cancer [4] - Tianen Kang's subsidiary received a drug registration acceptance notice for Lidocaine and Prilocaine aerosol [31] - Lisheng Pharmaceutical announced that its Aminophylline tablets passed the consistency evaluation for generic drugs [40] Share Buyback Plans - Hengyuan Coal Power plans to repurchase shares with a total amount not less than 200 million yuan and not exceeding 250 million yuan [13] Contract Wins - China Communication Signal Co. won contracts totaling approximately 5.26 billion yuan for 21 important projects in the railway and urban rail transit markets [37]

HRS-7535 片是一种新型口服小分子胰高血糖素样肽-1 受体(GLP-1R)激动剂，可以通过激活人的 GLP- 1R，促进胰腺的胰岛素分泌和降低胰高血糖素分泌并抑制胃排空，还可以通过影响中枢增强饱腹感和 抑制食欲，直接减少能量的摄入。临床前数据显示 HRS-7535 可显著改善动物慢性肾脏病(CKD)症状。 全球范围内尚无口服小分子 GLP-1R 激动剂上市。截至目前，HRS-7535 片相关项目累计研发投入约 36,940 万元(未经审计)。 智通财经APP讯，恒瑞医药(01276)发布公告，近日，江苏恒瑞医药股份有限公司(以下简称"公司")子公 司山东盛迪医药有限公司收到国家药品监督管理局(以下简称"国家药监局")核准签发关于 HRS-7535 片 的《药物临床试验批准通知书》，将于近期开展临床试验。 ...

HRS-7535 片是一种新型口服小分子胰高血糖素样肽-1 受体(GLP-1R)激动剂，可以通过激活人的 GLP- 1R，促进胰腺的胰岛素分泌和降低胰高血糖素分泌并抑制胃排空，还可以通过影响中枢增强饱腹感和 抑制食欲，直接减少能量的摄入。临床前数据显示 HRS-7535 可显著改善动物慢性肾脏病(CKD)症状。 全球范围内尚无口服小分子 GLP-1R 激动剂上市。截至目前，HRS-7535 片相关项目累计研发投入约 36,940 万元(未经审计)。 智通财经APP讯，恒瑞医药(01276)发布公告，近日，江苏恒瑞医药股份有限公司(以下简称"公司")子公 司山东盛迪医药有限公司收到国家药品监督管理局(以下简称"国家药监局")核准签发关于 HRS-7535 片 的《药物临床试验批准通知书》，将于近期开展临床试验。 ...

格隆汇1月29日丨恒瑞医药(01276.HK)公告，近日，江苏恒瑞医药股份有限公司子公司山东盛迪医药有 限公司收到国家药品监督管理局核准签发关于HRS-7535 片的《药物临床试验批准通知书》，将于近期 开展临床试验。现将相关情况公告如下： 药物名称：HRS-7535 片 剂 型：片剂 申请事项：临床试验 受 理 号：CXHL2501214、CXHL2501215、CXHL2501216 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，2025年 11 月 5 日受理的 HRS- 7535 片符合药品注册的有关要求，同意本品开展Ⅲ期临床试验。申请的适应症：本品拟用于治疗慢性 肾脏病。 ...