证券代码：600276 证券简称：恒瑞医药 公告编号：临 2026-012 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 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。 剂 型：注射剂 申请事项：临床试验 受 理 号：CXSL2500956 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 7 日受理的 SHR-1049 注射液符合药品注册的有关要求，同意本品开展单 药在晚期实体瘤中的临床试验。 二、药物的其他情况 SHR-1049 注射液是公司自主研发的创新型抗肿瘤药物，拟用于治疗晚期实 体瘤。经查询，目前国内外尚无同类药物获批上市。截至目前，SHR-1049 注射 液相关项目累计研发投入约为 2,600 万元(未经审计)。 三、风险提示 近日，江苏恒瑞医药股份有限公司（以下简称"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 SHR-1049 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。现将相关情况公告如下： 一、药物的基本情况 ...

格隆汇1月26日丨恒瑞医药(01276.HK)发布公告，近日，公司收到国家药监局核准签发关于SHR-1049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。SHR-1049注射液是公司自主研发的创 新型抗肿瘤药物，拟用于治疗晚期实体瘤。经查询，目前国内外尚无同类药物获批上市。 ...

每经AI快讯，1月26日，恒瑞医药（600276）(600276.SH)公告称，公司收到国家药监局核准签发关于 SHR-1049注射液的《药物临床试验批准通知书》，同意开展单药在晚期实体瘤中的临床试验。SHR- 1049注射液是公司自主研发的创新型抗肿瘤药物，拟用于治疗晚期实体瘤。经查询，目前国内外尚无同 类药物获批上市。 ...

格隆汇1月26日｜恒瑞医药公告，公司收到国家药品监督管理局核准签发关于SHR-1049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。SHR-1049注射液是公司自主研发的创新型抗肿瘤药 物，拟用于治疗晚期实体瘤。经查询，目前国内外尚无同类药物获批上市。截至目前，SHR-1049注射 液相关项目累计研发投入约为2,600万元(未经审计)。 ...

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。 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 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 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。 近日，江苏恒瑞医药股份有限公司（以下简称"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 SHR-1049 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。现将相关情况公 ...

行业定期报告 证券研究报告 医药生物 hyzqdatemark 2026 年 01 月 26 日 投资评级： 看好（维持） ——医药行业周报（26/1/19-26/1/23） 投资要点： 请务必仔细阅读正文之后的评级说明和重要声明 证券分析师 本周医药市场表现分析：1 月 19 日至 1 月 23 日，医药指数下跌 0.39%，相对沪深 300 指数 超额收益为 0.23%。本周，医药市场行情相对平淡，周五医药指数上涨 1.26%，其中仍然是 脑机接口、AI 医疗等主题性板块有一定表现，药店受政策影响亦表现较好。考虑到脑机接口 和 AI 医疗作为未来的产业趋势，板块有望反复活跃，创新药经过 25 年四季度的充分调整， 当前估值性价比高，建议关注相关板块表现。我们建议精选基本面强劲、前期调整充分的创 新药个股，看好未来股价有望走出新高度，同时建议积极关注医疗新科技等板块，以及 26 年 困境反转的底部个股。1）创新药建议关注，A 股）信立泰、泽璟制药、热景生物、科伦药业、 上海谊众、康弘药业、华纳药厂、前沿生物、福元医药、昂利康、恒瑞医药；港股）三生制 药、信达生物、康方生物、中国生物制药、科伦博泰、石药集团、 ...

Core Insights - The aging population in China is leading to an increase in cardiovascular diseases, with rising prevalence of chronic conditions such as hypertension and hyperlipidemia, driving demand for cardiovascular drugs [1][8] - There is a significant increase in health awareness among residents, leading to earlier screening and treatment of cardiovascular diseases, which expands the applicable population for cardiovascular medications [1][8] - The implementation of centralized drug procurement policies is causing a downward trend in drug prices, putting pressure on the overall market size, which is projected to decline to 954.1 billion yuan for traditional Chinese medicine and 1,415.8 billion yuan for chemical drugs by 2025 [1][8] Market Overview - Cardiovascular diseases encompass both cardiovascular and cerebrovascular diseases, primarily caused by conditions like hyperlipidemia, blood viscosity, atherosclerosis, and hypertension [2] - Cardiovascular drugs are classified into two main categories: cardiovascular system drugs and cerebrovascular system drugs, targeting various heart and brain-related conditions [2] Policy Environment - The pharmaceutical manufacturing industry, including cardiovascular drugs, is a key focus of national policy support, with various regulations aimed at correcting malpractices and promoting industry development [3][4] Industry Chain - The upstream of the cardiovascular drug industry includes chemical raw materials, traditional Chinese medicinal materials, and pharmaceutical packaging materials, while the midstream involves research, production, and registration processes [4][5] Demand Dynamics - Cardiovascular diseases are the leading cause of death in China, with hypertension cases expected to reach 370 million and coronary heart disease cases at 30 million by 2025, indicating a growing demand for cardiovascular medications [6][8] Competitive Landscape - The market has developed a dual competitive structure, with foreign companies dominating the chemical drug sector and local companies leading in traditional Chinese medicine, creating a competitive environment [10] - Notable domestic players include Shijiazhuang Pharmaceutical Group and Shandong Buchang Pharmaceutical, which have established strong market positions through unique products and effective distribution networks [10][11] Development Trends - The industry is shifting from reliance on generic drugs to innovation, focusing on high-value drug development, including targeted and biological drugs [12] - There is a growing integration of chronic disease management with digital tools, enhancing patient adherence and treatment precision [13] - Policy reforms are reshaping market dynamics, emphasizing high clinical value drugs and expanding the market for basic medications in primary healthcare [14] - The industry is moving towards a collaborative ecosystem, with increased internationalization efforts and participation in global clinical trials [15]

Core Insights - In 2025, China achieved a record high in overseas business development (BD) transactions for innovative drugs, with 157 deals totaling $135.655 billion, including an upfront payment of $7 billion [1][3][16] - The year 2025 marked a significant shift in the BD landscape, transitioning from a "1.0 era" of simple asset sales to a "2.0 era" characterized by deeper partnerships and higher value creation [5][16] Transaction Overview - The top three BD transactions in 2025 included a $13 billion deal between Qide Pharma and Biohaven & AimedBio, a $12.5 billion deal between Hengrui and GSK, and a $11.4 billion deal between Innovent Biologics and Takeda [2][11] - China accounted for 49% of the global total for BD transactions in 2025, surpassing the United States for the first time [2][11] Financial Metrics - The total upfront payments for BD transactions in China reached $7 billion in 2025, nearly doubling from $4.1 billion in 2024, with individual transaction upfront payment ratios increasing to approximately 5.2%-6.7% [7][16] - Milestone payments also saw significant activity, with at least 10 transactions triggering milestone payments in 2025, indicating a trend towards more structured financial agreements [9][16] Therapeutic Areas and Pipeline Stages - Oncology remained the primary focus of BD transactions, accounting for 51.4% of deals, although other areas such as immunology and metabolic diseases gained traction, rising to 34.1% [11][13] - The distribution of pipeline stages showed a shift towards later-stage projects, with 22% of transactions involving Phase III or marketed products, reflecting a preference for assets with established clinical data [13][16] Collaboration Models - The "Co-Co" model, which emphasizes joint development and commercialization, emerged as a new strategic direction in 2025, complementing traditional "License-out" and "NewCo" models [15][16] - This evolution in collaboration models indicates a trend towards deeper partnerships, allowing for shared risks and rewards, and enhancing the overall value proposition of BD transactions [15][16] Future Outlook - The demand for Chinese innovative drugs is expected to remain strong in 2026, driven by the approaching patent cliffs and increasing global competition, suggesting continued activity in BD transactions [21][22] - The industry is anticipated to further mature, focusing on quality and value in BD transactions, with an emphasis on long-term collaboration and mutual benefits [21][22]

Investment Rating - The report indicates a "Buy" rating for several companies within the pharmaceutical sector, including 恒瑞医药 (Hengrui Medicine), 百济神州-U (BeiGene), and others [22]. Core Insights - The pharmaceutical industry has seen a significant increase in BD (business development) activities, with Chinese pharmaceutical companies securing upfront payments exceeding $7.03 billion in 2025, marking a year-on-year growth of over 226.8% [15][20]. - The industry has a total market capitalization of approximately 544.85 billion yuan, with a TTM (trailing twelve months) P/E ratio of 38.5, significantly higher than the 14.1 P/E ratio of the CSI 300 index [3][6]. - The best-performing sub-sectors this week include offline pharmacies, hospitals, and medical R&D outsourcing, with year-to-date increases of 17.2%, 14.8%, and 10.7%, respectively [6][31]. Summary by Sections Industry Performance - The pharmaceutical index decreased by 0.39% this week, outperforming the CSI 300 index by 0.23 percentage points. Year-to-date, the pharmaceutical sector has risen by 6.66%, surpassing the CSI 300 index by 5.10 percentage points [6][24]. - The current valuation level (P/E-TTM) for the pharmaceutical industry stands at 30.31 times, with a premium of 65.36% over the entire A-share market [6][26]. Business Development Trends - In 2025, the domestic dual-antibody BD projects achieved upfront payments of $3.5 billion, a staggering increase of 414.7%, accounting for 49.8% of all BD upfront payments for the year [16]. - The ADC (Antibody-Drug Conjugates) sector has also seen substantial growth, with upfront payments reaching $1.63 billion, a 676.2% increase year-on-year [17]. - The GLP-1RA (Glucagon-Like Peptide-1 Receptor Agonists) segment reported upfront payments of $470 million, reflecting a 109.8% increase compared to 2024 [18]. Notable Collaborations - The report highlights significant collaborations, such as 舶望制药 (Bohua Pharmaceutical) partnering with Novartis to explore the potential of siRNA in hypertension treatment, securing an upfront payment of $160 million [19]. - The MNC (Multinational Corporation) procurement model remains dominant, with local companies securing $4.71 billion in upfront payments from MNCs, representing 67.0% of total BD upfront payments [20]. Recommended Companies - The report suggests a robust investment strategy focusing on companies like 恒瑞医药 (Hengrui Medicine), 百济神州-U (BeiGene), and others, which are expected to benefit from innovation and international expansion [20][21].

Investment Rating - The report maintains a "Buy" rating for the pharmaceutical and biotechnology sector, specifically highlighting companies like Yuyuan Pharmaceutical and CanSino Biologics for their promising developments in mRNA vaccines [1]. Core Insights - The mRNA vaccine sector is experiencing a breakthrough, with mRNA technology leading the shift towards efficient and personalized immunotherapy. This technology offers three core competitive advantages: rapid production capabilities, enhanced safety profiles, and flexibility in antigen design, which supports personalized treatment approaches [1][4]. - The report identifies a favorable ranking of sub-industries, with innovative drugs, research services, and CXO services being prioritized for investment. High-yield sectors include traditional Chinese medicine and pharmacies [10][11]. - Specific companies are recommended for investment based on various therapeutic angles, including PD1 PLUS, ADC, and small nucleic acids, with notable mentions such as Innovent Biologics, CanSino Biologics, and Yuyuan Pharmaceutical [10][12][13]. Summary by Sections Market Performance - The A-share pharmaceutical index has shown a year-to-date increase of 6.66%, outperforming the CSI 300 index by 5.10%. The Hang Seng Biotechnology Index has also seen a 12.40% increase [4][9]. - Sub-sectors such as pharmaceutical commerce (+4.26%) and raw materials (+2.41%) have performed well, while bioproducts and chemical pharmaceuticals have faced declines [4][9]. Clinical Developments - Corcept Therapeutics has reported positive results from its Phase III trial for relacorilant, indicating survival benefits for patients with platinum-resistant ovarian cancer. Meanwhile, Maiwei Biologics has initiated its first patient dosing in the U.S. for its CDH17-ADC innovative drug [1][4]. Investment Recommendations - The report suggests a diversified investment approach across various therapeutic areas, including: - PD1 PLUS: Focus on companies like 3SBio and Innovent Biologics - ADC: Companies such as InnoCare Pharma and Kintor Pharmaceutical - Small nucleic acids: Recommendations include Frontier Biotechnologies and Yuyuan Pharmaceutical - Traditional Chinese medicine: Companies like Zhaoke Pharmaceutical and Fangsheng Pharmaceutical are highlighted [10][12][13]. Fund Holdings - The report notes a decrease in the proportion of public fund holdings in the pharmaceutical sector, with a total holding of 6.67% as of Q4 2025, down 1.46 percentage points from the previous quarter [17][18]. Company Performance - Specific companies have been highlighted for their market performance, with notable increases in stock prices for companies like *ST Changyao (+70.37%) and Hualan Biological (+32.21%) [9]. This comprehensive analysis provides insights into the current state and future potential of the pharmaceutical and biotechnology industry, emphasizing the importance of mRNA technology and strategic investment in key companies.