Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-A2009, an antibody-drug conjugate targeting HER3 [1] Group 1 - SHR-A2009 specifically binds to HER3 on the surface of tumor cells, leading to internalization and transport to lysosomes, where it releases free toxins to kill tumor cells [1]

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-137 江苏恒瑞医药股份有限公司 关于回购公司 A 股股份的进展公告 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。 重要内容提示： | 回购方案首次披露日 | 2025/8/21 | | | | | | | --- | --- | --- | --- | --- | --- | --- | | 回购方案实施期限 | 2025 年 8 月 20 8 | 日~2026 | 年 | 月 | 19 | 日 | | 预计回购金额 | 100,000万元~200,000万元 | | | | | | | 回购用途 | □减少注册资本 √用于员工持股计划或股权激励 □用于转换公司可转债 | | | | | | | | □为维护公司价值及股东权益 | | | | | | | 累计已回购股数 | 0万股 | | | | | | | 累计已回购股数占总股本比例 | 0% | | | | | | | 累计已回购金额 | 0万元 | | | | | | | 实际回购价格区间 | /元 ...

证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-135 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。 二、药物的其他情况 注射用 SHR-A2009 是一款以 HER3 为靶点的抗体药物偶联物，可特异性结合 肿瘤细胞表面上的 HER3，进而被内吞至细胞内并转运至溶酶体中，水解释放游 离毒素，杀伤肿瘤细胞。全球尚未有同类药物获批上市。截至目前，注射用 SHR-A2009 相关项目累计研发投入约 19,774 万元。 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"）子公司苏州盛迪亚 生物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 发关于注射用 SHR-A2009 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 药物名称：注射用 SHR-A2009 剂 型：注射剂 申请事项：临床试验 受 理 号：CXSL2500476 审批结论：根据《中华人民共和国药品管理法 ...

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 HRS-7172 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： 证券代码：600276 证券简称：恒瑞医药 公告编号：临 2025-136 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 一、药物的基本情况 药物名称：HRS-7172 片 特此公告。 江苏恒瑞医药股份有限公司董事会 二、药物的其他情况 HRS-7172 片是公司自主研发的新型抗肿瘤小分子抑制剂。经查询，目前国 内外尚无同类药物获批上市。截至目前，HRS-7172 片相关项目累计研发投入约 2,841 万元。 三、风险提示 根据我国药品注册相关的法律法规要求，药物在获得药物临床试验批准通知 书后，尚需开展临床试验并经国家药监局审评、审批通过后方可生产上市。药品 从研制、临床试验报批到投产的周期长、环节多，药品研发及至上市容易受到一 些不确定性因素的影响， ...

Core Viewpoint - Heng Rui Medicine has received approval from the National Medical Products Administration for clinical trials of HRS-7172 tablets, a new type of anti-tumor small molecule inhibitor, with no similar drugs approved for market domestically or internationally [1] Group 1 - The company has developed HRS-7172 tablets, which are a novel anti-tumor small molecule inhibitor [1] - The approval for HRS-7172 marks a significant milestone as there are currently no similar drugs available in the market [1] Group 2 - The company's subsidiary, Suzhou Shengdiya Biopharmaceutical, has also received approval for clinical trials of SHR-A2009 injection, an antibody-drug conjugate targeting HER3 [1] - SHR-A2009 specifically binds to HER3 on the surface of tumor cells, leading to internalization and release of cytotoxic agents within the cells [1] - There are no similar drugs approved globally for SHR-A2009, indicating a unique position in the market [1]

Group 1 - The overall trend of main funds showed a net outflow of 571.43 billion yuan on September 1, with a net ratio of -2.08%, indicating cautious operations by main funds [4] - Large orders experienced significant outflows, with super large orders net outflowing 244.45 billion yuan and large orders net outflowing 326.98 billion yuan [4] - In contrast, medium and small orders showed positive inflows, with medium orders net inflowing 33.89 billion yuan and small orders net inflowing 537.54 billion yuan, suggesting optimism among retail investors [4] Group 2 - Main funds primarily flowed into the medical sector, with significant inflows in medical services (15.29 billion yuan), biological products (11.80 billion yuan), and chemical pharmaceuticals (11.27 billion yuan) [5] - Notable stocks in the medical services sector included WuXi AppTec, while Changchun High & New and Heng Rui Medicine led inflows in their respective categories [5] - The technology sector, particularly software development and semiconductors, attracted small order inflows, with software development seeing 44.35 billion yuan and semiconductors 37.19 billion yuan [5] Group 3 - In August, main funds experienced a net outflow of 8020.33 billion yuan, a significant increase from July's outflow of 6721.3 billion yuan, indicating a more cautious stance [9] - Small order funds continued to show strong inflows, with a net inflow of 8212.6 billion yuan in August, maintaining a trend of consistent inflows since April [9] - The market is characterized by retail investors entering as institutions stabilize their positions, leading to increased volatility but overall healthy market conditions [9]

Group 1 - The core point of the article is that Heng Rui Pharmaceutical (600276.SH) has not yet started its share repurchase program as of August 31, 2025 [1] - As of the date of the announcement, there is no discrepancy between the implementation status of the repurchase and the repurchase plan [1]

Investment Rating - The investment rating for the biotechnology industry is "Positive" (maintained) [1] Core Insights - The small molecule GLP-1RA market is expected to provide new incremental space for weight loss and diabetes management, with significant interest from multinational corporations (MNCs) accelerating their involvement in this sector [7][25] - The leading product in the small molecule GLP-1RA space is Orforglipron from Eli Lilly, which has completed multiple global Phase III clinical trials and is positioned to submit a New Drug Application (NDA) in the second half of 2025 [25][26] - Domestic companies are making substantial progress in the small molecule GLP-1RA pipeline, with several candidates entering late-stage clinical trials, indicating strong potential for commercialization and international expansion [19][25] Summary by Sections 1. Development Prospects of Small Molecule GLP-1RA - Oral GLP-1 drugs offer advantages such as ease of use and high patient compliance, with over 75% of initial treatment patients preferring daily oral therapy [14] - The small molecule GLP-1RA market is characterized by low costs and flexibility in usage scenarios, with significant recent business development (BD) transactions [14][23] 2. MNCs Accelerating Small Molecule GLP-1RA Pipeline - Eli Lilly's Orforglipron is the fastest progressing small molecule GLP-1RA product globally, with three Phase III trials achieving primary endpoints [25][27] - Other major pharmaceutical companies like AstraZeneca and Roche are also advancing their small molecule GLP-1RA pipelines, with several candidates in Phase II trials [29][30] 3. Pharmacokinetic Characteristics Impacting Efficacy - Pharmacokinetic features are crucial for the efficacy of small molecule GLP-1RA, with companies exploring new formulations to enhance solubility and absorption [6][19] 4. Investment Recommendations - The report recommends several companies as potential beneficiaries in the small molecule GLP-1RA space, including Innovent Biologics, East China Pharmaceutical, and others, highlighting their strong clinical development and commercialization potential [7][19]

Core Viewpoint - The innovative drug sector has led the market this year, with the Hang Seng Innovative Drug ETF (159316) rising over 86% since April 9 [1][4]. Fund Inflows - In the last 60 days, the Hang Seng Innovative Drug ETF (159316) has seen a net inflow of 1.547 billion yuan, bringing its latest scale to 1.968 billion yuan [3]. Breakthroughs - The strong performance of the innovative drug sector is attributed to a series of favorable developments, particularly in international markets. A significant boost occurred on September 1 when Hengrui Medicine announced conditional approval from the National Medical Products Administration for its self-developed innovative drug, SHR2554, for treating relapsed or refractory peripheral T-cell lymphoma [4][5]. - SHR2554 represents a major breakthrough as China's first self-developed EZH2 inhibitor, indicating a shift from "Me-too" drugs to genuine innovation, showcasing China's capability to compete in global markets [5][6]. Incremental Growth - From January to July this year, Chinese innovative drug companies licensed out nearly 80 billion yuan, a year-on-year increase of over 160%. Several companies have announced large licensing agreements, indicating a growing trend in international collaborations [7][9]. - The innovative drug industry in China is characterized by increasing foundational innovation capabilities, expanding market size, and improving international market share. The number of self-developed innovative drugs surpassed that of the U.S. in 2020, with 592 drugs in development by 2021, accounting for 22% of the global total [9][11]. Qualitative Changes - The Hang Seng Innovative Drug Index has rebounded significantly after a steep decline, with a 73% drop from its peak in June 2021 to July 2024, followed by a doubling in value over the past year [13][14]. - Several companies have reported profitability for the first time, with notable net profits from companies like BeiGene and Innovent Biologics, indicating a shift towards sustainable revenue sources [15][16]. - The innovative drug sector is transitioning from a phase of heavy R&D investment to one of realizing results, supported by valuation recovery, earnings growth, accelerated international expansion, and favorable policies [18]. Conclusion - The innovative drug sector is expected to continue benefiting from multiple catalysts, including upcoming international conferences and potential interest rate cuts, which could enhance global liquidity and favorably impact the sector [18].

Market Performance - The Hang Seng Index closed at 25,617, up 2.15% for the day and up 27.70% year-to-date [1] - The Hang Seng Tech Index rose 2.20% to 5,798, with a year-to-date increase of 29.79% [1] - The Shanghai Composite Index increased by 0.46% to 3,875, with a year-to-date rise of 15.63% [1] Currency and Commodity Overview - The Renminbi Index stood at 96.570, showing a 0.90% increase over the last month but a 3.33% decline over six months [2] - Brent crude oil price was $68.170 per barrel, down 0.86% over the last month and down 2.68% over six months [2] - Gold prices increased by 3.26% over the last month, reaching $3,473.27 per ounce, and rose 20.07% over six months [2] Company News - Alibaba's stock surged by 18.50% to HKD 137.10 after several major banks raised their target prices following the company's earnings report [5][21] - The pharmaceutical sector saw significant gains, with CSPC Pharmaceutical rising 9.14% and WuXi Biologics increasing by 8.37% [5][21] - Hengrui Medicine's HRS9531 injection received acceptance for market approval from the National Medical Products Administration, targeting long-term weight management for adults with obesity-related conditions [12] Economic Indicators - China's August Manufacturing PMI rose to 50.5, surpassing market expectations of 49.5, indicating a recovery in manufacturing activity driven by increased new orders [13][14] - Hong Kong's retail sales value for July increased by 1.8% year-on-year, falling short of the expected 2.5% growth [10][11] IPO and Market Trends - Recent IPOs have shown strong performance, with Jiaxin International Resources listing at a price of HKD 33.82, reflecting a first-day gain of 177.84% [28] - The upcoming IPO of Daxing Technology is set for September 9, 2025, with a proposed offer price of HKD 49.5 [28] Sector Performance - The biotechnology sector led gains with a 3.58% increase, while the automotive sector saw a decline of 2.00% [24] - The pharmaceutical sector also performed well, contributing to the overall positive market sentiment [24]