Core Viewpoint - Heng Rui Medicine has received acceptance for its drug application for Haiqubopai Ethanolamine Tablets from the National Medical Products Administration, aimed at treating chemotherapy-induced thrombocytopenia in adult patients [1][2] Group 1: Drug Approval and Clinical Trials - The National Medical Products Administration has issued an acceptance notice for the drug application of Haiqubopai Ethanolamine Tablets, which is indicated for adult patients with chemotherapy-induced thrombocytopenia [1] - The Phase III clinical trial (SHR8735-301) for Haiqubopai Ethanolamine Tablets achieved its primary endpoint in May 2025, demonstrating significant efficacy compared to the control group with good safety and tolerability [1] Group 2: Existing Approvals and Market Context - Haiqubopai Ethanolamine Tablets have previously been approved for two indications: chronic primary immune thrombocytopenia in adults with poor response to corticosteroids and immunoglobulins, and severe aplastic anemia in adults with poor response to immunosuppressive therapy [2] - The drug is an oral non-peptide thrombopoietin receptor (TPO-R) agonist that promotes platelet production through the activation of TPO-R mediated STAT and MAPK signaling pathways [2] - Similar products available in the international market include Eltrombopag, Avatrombopag, and Lusutrombopag, with a combined global sales forecast of approximately $2.59 billion for 2024 [2] - The cumulative R&D investment for Haiqubopai Ethanolamine Tablets has reached approximately 445.87 million yuan [2]

Group 1 - Company and its subsidiaries received approval from the National Medical Products Administration for clinical trials of HRS-4508 tablets, SHR-A1811 injection, Adebali monoclonal antibody injection, and Bevacizumab injection [1] - HRS-4508 is a novel, efficient, selective tyrosine kinase inhibitor that inhibits tumor cell proliferation [1] - The total R&D investment for HRS-4508 project is approximately 36.42 million yuan [1] Group 2 - SHR-A1811 injection binds to HER2-expressing tumor cells and induces apoptosis through a unique mechanism [2] - SHR-A1811 was approved for use in treating adults with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 mutations [2] - The total R&D investment for SHR-A1811 project is approximately 1.26 billion yuan [2] Group 3 - Bevacizumab is a humanized anti-VEGF monoclonal antibody that has been approved in multiple countries since 2004 [3] - The global sales of Bevacizumab are projected to be approximately 5.655 billion USD in 2024 [3] - The total R&D investment for Bevacizumab injection project is approximately 3.45 million yuan [3]

恒瑞医药（600276）(600276.SH)公告，公司及子公司苏州盛迪亚生物医药有限公司、上海盛迪医药有 限公司收到国家药品监督管理局核准签发关于HRS-4508片、注射用SHR-A1811、阿得贝利单抗注射 液、贝伐珠单抗注射液的《药物临床试验批准通知书》，将于近期开展临床试验，具体为：HRS-4508 联合其他抗肿瘤治疗HER2通路异常的实体瘤的开放、多中心的ⅠB/Ⅱ期临床研究。 ...

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-117 阿得贝利单抗注射液是公司自主研发的人源化抗 PD-L1 单克隆抗体，能通过 特异性结合 PD-L1 分子从而阻断导致肿瘤免疫耐受的 PD-1/PD-L1 通路，重新激 活免疫系统的抗肿瘤活性，从而达到治疗肿瘤的目的。公司阿得贝利单抗注射液 （商品名：艾瑞利）已于 2023 年 3 月获批上市，获批的适应症为与卡铂和依托 泊 苷 联 合 用 于 广 泛 期 小 细 胞 肺 癌 患 者 的 一 线 治 疗 。 国 外 有 同 类 产 品 Atezolizumab （ 商 品 名 ： Tecentriq ） 、 Avelumab( 商 品 名 ： Bavencio) 和 Durvalumab(商品名：Imfinzi)于美国获批上市销售，其中 Atezolizumab 和 Durvalumab 已在中国获批上市。国内有康宁杰瑞/思路迪药业的恩沃利单抗、基 石药业的舒格利单抗和正大天晴药业的贝莫苏拜单抗等同类产品获批上市。经查 询，2024 年 Atezolizumab、Avelumab 和 Durvalumab 全球销售额合计约为 96.48 ...

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]

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]