证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-118 江苏恒瑞医药股份有限公司 关于药品上市许可申请获受理的提示性公告 一、药品的基本情况 药品名称：海曲泊帕乙醇胺片 剂型：片剂 受理号：CXHS2500096 申报阶段：上市 申请人：江苏恒瑞医药股份有限公司 拟定适应症（或功能主治）：用于化疗为主的抗肿瘤治疗所致血小板减少症 成人患者。 二、药品的临床试验情况 2025 年 5 月，海曲泊帕乙醇胺片Ⅲ期临床试验（SHR8735-301）达到了方案 预设的主要研究终点。该研究是在化疗为主的抗肿瘤治疗所致血小板减少症患者 中评价海曲泊帕乙醇胺片有效性和安全性的多中心、随机、双盲、安慰剂对照的 Ⅲ期临床研究，由哈尔滨市第一医院马军教授和中国药科大学附属南京天印山医 院秦叔逵教授担任主要研究者，研究共入组 213 例化疗为主的抗肿瘤治疗所致血 小板减少症成人患者。研究结果表明，试验组在主要疗效终点上显著优于对照组， 且安全性和耐受性良好。 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 ...

Core Viewpoint - Heng Rui Medicine (600276.SH) has received a notice from the National Medical Products Administration (NMPA) regarding the acceptance of its drug listing application for Haequparib Ethanolamine Tablets, which are intended for the treatment of chemotherapy-induced thrombocytopenia in adult patients [2] Company Summary - The drug application is specifically aimed at addressing thrombocytopenia caused by chemotherapy, indicating a focus on oncology treatments [2] - The acceptance of the application marks a significant step for the company in expanding its product portfolio in the oncology sector [2]

Market Overview - The Hong Kong stock market saw all three major indices rise last week, with the Hang Seng Index increasing by 1.65% to close at 25,270.07 points, the Tech Index rising by 1.52% to 5,543.17 points, and the National Enterprises Index up by 1.62% to 9,039.09 points [1] - In the A-share market, the Shanghai Composite Index rose by 0.83% to 3,696.77 points, the Shenzhen Component Index increased by 1.6% to 11,634.67 points, and the ChiNext Index surged by 2.61% to 2,534.22 points. The total trading volume decreased by 34.597 billion yuan to 2,244.612 billion yuan [2] Pharmaceutical Industry Insights - Chinese pharmaceutical giants, Heng Rui Medicine and Hansoh Pharmaceutical, are expected to report significant profit improvements driven by the launch of innovative drugs and revenue from technology licensing. Heng Rui's net profit for the first half of the year is projected to grow by 40% to 4.1 billion yuan, with revenue increasing by 9% to 15.7 billion yuan. For the full year, profits are expected to rise by 28% to 8.1 billion yuan [3] - Heng Rui is actively optimizing its revenue structure, with the share of generic drug revenue in total revenue dropping from 62% in 2022 to 43% last year, and expected to further decline to 23% by 2027. The company has signed 14 out-licensing agreements since 2018, receiving 600 million USD in upfront payments and potential milestone payments of up to 13.4 billion USD [3] - Hansoh Pharmaceutical is also performing strongly, with a projected net profit increase of over 51% to 2.5 billion yuan for the first half of the year. Its annual profit is expected to grow by 6.2% to 4.64 billion yuan, with innovative drug sales projected to exceed 10 billion yuan, contributing approximately 80% of total revenue, up from 45% in 2021 [3] Banking and Insurance Sector Performance - In the first half of 2025, Chinese commercial banks achieved a cumulative net profit of 1.2 trillion yuan, although profitability indicators showed a slight decline. The average capital return rate was 8.19%, and the average asset return rate was 0.63%, indicating a slowdown in profit growth. However, the banks' risk resistance capacity has improved, with non-performing loans slightly decreasing to 3.4 trillion yuan and the non-performing loan ratio dropping to 1.49% [4] - The insurance industry maintained steady growth in the first half of 2025, with original insurance premium income increasing by 5.1% to 3.7 trillion yuan and the number of new policies rising by 11.1% to 52.4 billion. Despite an increase in claims and payouts, the industry's overall solvency remained robust, with comprehensive and core solvency ratios at 204.5% and 147.8%, respectively [4] - The banking sector has increased support for the real economy, with inclusive loans for small and micro enterprises reaching 36 trillion yuan, a year-on-year growth of 12.3%. Additionally, inclusive agricultural loans increased by 1.1 trillion yuan to 1.39 trillion yuan, reflecting a strong response to policy initiatives [5]

Group 1 - The Shanghai 180 Index (000010) has shown a strong increase of 1.12% as of August 18, 2025, with notable gains from stocks such as Stone Technology (688169) up 14.10%, Northern Rare Earth (600111) up 10.00%, and Great Wall Motors (601633) up 8.32% [3] - The Shanghai 180 ETF Index Fund (530280) has risen by 0.44%, marking its fifth consecutive increase, with a latest price of 1.13 yuan. Over the past week, the fund has accumulated a rise of 2.46%, ranking 1st among comparable funds [3] - The Shanghai 180 Index employs a barbell strategy consisting of 90% dividend stocks and 10% technology stocks, providing a good option for equity market allocation. This strategy allows for potential benefits from rapid technological development while maintaining a solid dividend base [3] Group 2 - As of July 31, 2025, the top ten weighted stocks in the Shanghai 180 Index include Kweichow Moutai (600519), Hengrui Medicine (600276), and Ping An Insurance (601318), with these stocks collectively accounting for 25.4% of the index [4] - The weightings of the top stocks are as follows: Kweichow Moutai at 4.92%, Ping An Insurance at 2.75%, and Hengrui Medicine at 2.62%, among others [6]

Investment Rating - The report does not explicitly state an investment rating for the industry, but it indicates a positive trend in the pharmaceutical and biotechnology sector with a weekly increase of 3.08% [3][8]. Core Insights - The pharmaceutical and biotechnology sector outperformed the Wind All A index and the CSI 300 index during the week of August 11 to August 15, with notable gains in medical research outsourcing (7.77%), hospitals (5.59%), and medical consumables (4.47%) [3][8]. - The upcoming launch of the commercial insurance innovative drug directory is expected to activate the domestic high-end payment market for innovative drugs, with 121 drug names passing preliminary review [3][8]. - The World Conference on Lung Cancer (WCLC) will take place from September 6 to 9, showcasing significant research advancements in lung cancer, with domestic research playing an increasingly important role [3][8]. Market Weekly Review - The pharmaceutical and biotechnology sector rose by 3.08%, outperforming the Wind All A index (2.95%) and the CSI 300 index (2.37%) [3][8]. - Medical research outsourcing, hospitals, and medical consumables led the sector's gains, while offline pharmacies, blood products, and medical circulation experienced declines [3][8]. - Notable individual stock performances included Sino Medical (69.1%), Innovation Medical (51.5%), and Guangsheng Tang (40.7%) for gains, while *ST Suwu (-16.8%), ST Sansheng (-15.2%), and Nanhua Biological (-14.2%) faced significant losses [3][11]. Industry News and Key Company Announcements - The National Medical Insurance Administration announced the preliminary review of the 2025 National Basic Medical Insurance drug directory and the commercial insurance innovative drug directory [3][13]. - Novo Nordisk received accelerated FDA approval for its therapy Wegovy for treating non-alcoholic steatohepatitis (NASH) [3][13]. - Yunnan Baiyao approved a full acquisition of An Guo Shi Ju Yao Tang Pharmaceutical Co., Ltd. for 660 million RMB to enhance its traditional Chinese medicine business [3][15]. - Insmed's DPP1 inhibitor Brensocatib received FDA approval for treating non-cystic fibrosis bronchiectasis [3][14].

Core Viewpoint - The surge of pharmaceutical companies listing on the Hong Kong Stock Exchange (HKEX) reflects a growing interest in the biotech sector, driven by innovative drug development and supportive regulatory frameworks [1][2][3]. Group 1: Market Activity - In 2023, 14 biopharmaceutical and medical device companies have listed on HKEX, raising a total of 182.25 billion HKD, with 36 more companies in the pipeline [2]. - The rapid development of innovative drugs is closely linked to the increase in listings, with 43 innovative drugs approved in the first half of the year, a 59% year-on-year increase [2]. - The Hang Seng Biotechnology Index has doubled in value this year, indicating strong market performance in the biotech sector [2]. Group 2: Regulatory and Capital Support - The introduction of the "Science and Technology Enterprises Special Line" and the 18A listing rule has facilitated early and customized listing guidance for innovative drug companies [3]. - Since the implementation of the 18A rule, 77 biotech companies have gone public, demonstrating the positive impact of regulatory reforms on the industry [3]. - Increased liquidity and capital inflow, particularly from foreign investments, have significantly improved the valuation and liquidity of the biotech sector [3]. Group 3: Company Performance and Evaluation Criteria - Companies with strong clinical data and rapid pipeline advancement, particularly in oncology, autoimmune diseases, and metabolic disorders, are attracting high valuations [6]. - The focus of investors is shifting from the quantity of drug pipelines to the quality and clinical value of the research outcomes [5][6]. - Successful recent listings, such as Zhonghui Biotech-B and Weilizhibo-B, highlight the market's preference for companies with innovative therapies and strong clinical trial results [6].

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry [1] Core Insights - The upcoming World Conference on Lung Cancer (WCLC) is expected to showcase significant advancements in innovative drugs, generating new business development expectations [1] - The A-share pharmaceutical index has increased by 3% this week and 25% year-to-date, outperforming the CSI 300 by 0.7% and 18.2% respectively [4][9] - The report highlights the strong performance of the pharmaceutical sector, particularly in innovative drugs, research services, and CXO [10][11] Industry Trends - The WCLC will take place from September 6 to September 9, 2025, in Barcelona, featuring over 1,500 presentations, with a significant number from Chinese researchers [17][18] - Chinese innovation is prominently represented, with over 400 submissions, indicating a shift towards the commercialization of innovative drugs [18][19] Stock Performance - Notable stock performances include a 69% increase for Sainuo Medical and a 94% increase for Paig Biological in the H-share market [4][9] - The report provides a detailed overview of stock performance, highlighting both top gainers and losers in the pharmaceutical sector [9][13] Recommendations - The report suggests a focus on specific sub-sectors, ranking them as follows: innovative drugs > research services > CXO > traditional Chinese medicine > medical devices > pharmacies [10] - Specific stock recommendations include companies like Bory Pharmaceutical, Singlera Genomics, and Innovent Biologics based on various therapeutic angles [11][12]

Investment Rating - The report maintains an "Accumulate" rating for the pharmaceutical and biotechnology industry [6] Core Views - The report emphasizes that the second wave of innovation in pharmaceuticals is just beginning, with a focus on disruptive technologies and a potential bull market driven by innovative drugs [2][12][13] - The PD-1 Plus pipeline is highlighted as a significant trend, with various companies actively developing dual-target and triple-target drugs [17][21] Summary by Sections Recent Performance - The pharmaceutical index increased by 3.08% during the week of August 11-15, underperforming the ChiNext index but outperforming the CSI 300 index [11] - The market showed strong momentum, particularly in innovative drugs, with significant movements in both large-cap and small-cap stocks [12] Future Outlook - The report suggests a continued optimistic view on innovative drugs, with a focus on overseas major drugs and small-cap technology revolutions as key investment themes [13] - Specific strategies include balancing investments in new technologies like brain-computer interfaces and AI in medicine while continuing to explore innovative drugs [13] Investment Strategy - The report outlines a detailed investment strategy focusing on innovative drugs, including major overseas players and small-cap technology companies [14] - Key companies mentioned include: - Overseas Major Drugs: Innovent Biologics, 3SBio, and others [14] - Small-Cap Technology Revolution: Junshi Biosciences, Zai Lab, and others [14] - New Technologies: Companies involved in brain-computer interfaces and AI in healthcare [16] PD-1 Plus Pipeline - The PD-1/VEGF dual antibodies are identified as critical in the current research landscape, with several companies like CanSino Biologics and 3SBio making significant advancements [17][18] - The report highlights the competitive landscape and the potential for new therapies to emerge from ongoing clinical trials [19][20] Market Trends - The report notes that the innovation drug index has outperformed the pharmaceutical index and the CSI 300 index since the beginning of 2025, indicating a strong market trend towards innovative pharmaceuticals [47][48]

Investment Rating - The industry investment rating is "Positive" (maintained) [1] Core Insights - The report highlights the transformation of China's medical insurance system from a "single basic coverage" model to a "basic insurance + commercial insurance supplementary" dual-track system, marked by the introduction of the commercial insurance innovative drug directory [5][13] - The commercial insurance innovative drug directory primarily focuses on high-value innovative drugs in oncology, immunology, and rare diseases, providing a new pathway for these drugs to gain market access [6][20] - The report indicates that the inclusion of innovative drugs in both the basic and commercial insurance directories is expected to lead to rapid revenue growth for related companies, benefiting patients and driving growth for innovative pharmaceutical firms [6][29] Summary by Sections Section 1: National Drug Review and Commercial Insurance Directory - The announcement of the national drug review results and the debut of the commercial insurance innovative drug directory occurred on August 12, 2025, indicating a significant policy shift [5][13] - The commercial insurance directory includes 121 drugs, focusing on those with high clinical value and significant patient benefits, particularly in oncology and rare diseases [20][27] - The report emphasizes that the commercial insurance directory allows for a more flexible pricing mechanism, which does not count towards hospital drug expenditure ratios, thus facilitating the market entry of high-value innovative drugs [28][24] Section 2: Market Performance and Trends - In August 2025, the pharmaceutical and biotechnology sector saw a 3.08% increase, outperforming the CSI 300 index by 0.7 percentage points [2][10] - The medical research outsourcing sector experienced the highest growth, while the offline pharmacy sector faced declines [10][12] - The report notes that the inclusion of over 20 traditional Chinese medicines in the 2025 basic medical insurance directory, primarily unique products, reflects a growing recognition of traditional medicine [6][29] Section 3: Recommended Stocks and Beneficiaries - Recommended stocks in the pharmaceutical and biotechnology sector include companies such as Heng Rui Medicine, East China Medicine, and Innovent Biologics, among others [7] - The report also highlights potential beneficiaries in the CXO sector, including WuXi AppTec and Tigermed, as well as companies in the medical device and service sectors [7][29]

Investment Rating - The report maintains a "Recommended" investment rating for the pharmaceutical industry [1] Core Views - The global GLP-1 market is expanding steadily, presenting strategic opportunities for Chinese companies [3] - Chinese pharmaceutical companies are increasingly recognized in global innovative drug transactions, contributing nearly 50% of total transaction value and over 30% of transaction volume [2] - The CXO industry is expected to gradually recover, with a notable increase in orders anticipated in Q3 [7] - The 2025 medical insurance negotiation and commercial insurance innovative drug directory work has commenced, with a focus on orphan drugs and breakthrough treatment varieties [8] Summary by Sections 1. Pharmaceutical Market Tracking - The pharmaceutical industry outperformed the CSI 300 index by 0.7% in the past week, with a weekly increase of 3.08% [22] - Over the past month, the pharmaceutical industry index increased by 11.07%, surpassing the CSI 300 index by 6.51% [25] 2. Pharmaceutical Sector Trends and Valuation - The current PE (TTM) for the pharmaceutical industry index is 39.94, above the 5-year historical average of 31.83 [44] 3. Recent Research Achievements - The report highlights various research achievements, including the deepening understanding of the GLP-1 drug market and its implications for innovative drug development [46] 4. Recent Industry Policies and News - The National Medical Insurance Administration has initiated the preliminary review of the 2025 medical insurance drug directory, with 121 drug names passing the initial review [8][49] - Significant clinical trial approvals and new drug applications have been reported, indicating active development in the pharmaceutical sector [49][50] 5. Stock Recommendations - The report recommends stocks in the weight loss field, CAR-T technology, and CXO companies, highlighting specific companies such as Zhongsheng Pharmaceutical and Anke Biotechnology [9]