Investment Rating - The report rates the pharmaceutical industry as "Overweight" indicating a positive outlook for the sector compared to the overall market performance [4][3]. Core Insights - The pharmaceutical sector saw a weekly increase of 1.3%, outperforming the Shanghai Composite Index which rose by 0.8% [5][4]. - The overall valuation of the pharmaceutical sector is at 27.7 times PE (2025E), ranking 6th among 31 primary industries [7][12]. - Key events include the official launch of Hong Kong IPO by Heng Rui Pharmaceutical, aiming to issue approximately 225 million H shares with a maximum fundraising of 13.08 billion HKD [13][4]. - A collaboration between Jianyou and Shuangcheng for the injection of paclitaxel (albumin-bound) received FDA approval, highlighting significant market opportunities [14][4]. Market Performance - The pharmaceutical bio index ranked 11th among 31 primary sub-industries, with various sub-sectors showing mixed performance: raw materials (+3.8%), chemical preparations (+1.0%), and traditional Chinese medicine (+1.7%) [4][5]. - The report notes that the pharmaceutical sector's performance is driven by innovations and regulatory approvals, which are crucial for future growth [4][14]. Key Company Developments - Heng Rui Pharmaceutical's IPO is set to take place from May 15 to May 20, with the final price expected to be determined by May 22 [13][4]. - The collaboration between Jianyou and Shuangcheng is expected to generate significant revenue through profit-sharing agreements following FDA approval [14][4]. Valuation Metrics - The report provides a detailed valuation table for key companies in the pharmaceutical sector, indicating projected EPS and PE ratios for 2025 to 2027 [17][4].

证券代码：002693 证券简称：*ST双成 公告编号：2025-035 海南双成药业股份有限公司 关于注射用紫杉醇（白蛋白结合型）ANDA 获得美国 FDA 上市许可的公告 ③ 胰腺癌，紫杉醇与吉西他滨联合用于胰腺转移性腺癌的一线治疗。 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚 假记载、误导性陈述或重大遗漏。 风险提示： 药品国际市场的销售会因为海外法规政策和市场环境的变化、汇率波动等因 素而受到影响。敬请广大投资者谨慎投资，注意防范投资风险。 海南双成药业股份有限公司（以下简称"公司"）于近日收到美国食品和药 品监督管理局（以下简称"FDA"）的通知，公司向美国 FDA 提交的注射用紫杉 醇（白蛋白结合型）简略新药申请（以下简称"ANDA"）已获得美国 FDA 的上市 许可批准。美国 FDA 对公司递交的注射用紫杉醇（白蛋白结合型）ANDA 申报资 料进行了全面技术审评，认定公司的产品与原研药品生物等效和疗效等效 （bioequivalent and therapeutically equivalent）。现将相关信息公告如下： 一、药品基本情况 1、药物名称：注射用紫杉醇（白蛋白 ...

Group 1 - The ST sector showed strong performance in the morning, with several stocks experiencing significant gains [1] - Notable stocks that reached the daily limit include *ST Shuangcheng, *ST Zhengping, *ST Wanfang, *ST Yatai, *ST Jianyi, *ST Bosen, and *ST Shengxun, among nearly 20 stocks [1]

Group 1: Company Performance and Strategies - The company plans to increase R&D investment to enhance product market share and revenue [1][3][6] - Expansion of entrusted business to improve revenue generation capabilities [1][3][6] - Optimization of operational processes to reduce operating costs and enhance profitability [1][3][6] - Streamlining organizational structure to improve operational efficiency and control labor costs [1][3][6] - Expansion of export activities to create new profit growth points [1][3][6] Group 2: Risk Management and Future Plans - The company is actively taking measures to mitigate delisting risks, including adapting to new healthcare policies and participating in procurement [6][9] - Focus on maintaining existing customer orders in the peptide business while expanding customer channels [7][9] - Commitment to advancing the approval of products under review and engaging in international business development activities [7][9] - Emphasis on cost control measures to enhance efficiency and reduce waste [7][9] Group 3: Acquisition and Restructuring - The company currently has no acquisition plans, and all relevant information will be disclosed through designated media [2][4][8] - Suggestions from investors regarding restructuring and acquisitions have been acknowledged, but no concrete plans are in place [2][3][4][8]

截至5月13日收盘，阿尔茨海默概念上涨1.74%，位居概念板块涨幅第5，板块内，24股上涨，华大基 因、迪安诊断、美年健康等涨幅居前，分别上涨14.55%、8.27%、6.72%。跌幅居前的有*ST双成、金凯 生科、联影医疗等，分别下跌4.96%、1.15%、0.80%。 今日涨跌幅居前的概念板块 | 代码 | 简称 | 今日涨跌幅 | 今日换手率 | 主力资金流量（万 | 主力资金净流入比率 | | --- | --- | --- | --- | --- | --- | | | | （%） | （%） | 元） | （%） | | 300676 | 华大基 因 | 14.55 | 5.13 | 12606.52 | 10.91 | | 000766 | 通化金 马 | 4.09 | 4.77 | 7912.36 | 9.04 | | 600789 | 鲁抗医 药 | 2.26 | 11.15 | 6213.39 | 5.96 | | 688068 | 热景生 物 | 2.40 | 3.98 | 3651.30 | 9.40 | | 002044 | 美年健 康 | 6.72 | 5.71 | 3326.88 ...

Core Viewpoint - The company has received marketing authorization for injectable bivalirudin from the Therapeutic Goods Administration (TGA) of Australia, indicating its capability to sell the product in Australia, which is expected to positively impact the company's overseas market expansion and performance [1][2]. Group 1: Product Information - Product Name: Injectable Bivalirudin [1] - Dosage Form: Injection [1] - Specification: 250mg [1] - Indication: Used as an anticoagulant for patients with high-risk acute coronary syndrome (ACS) undergoing early invasive treatment and those receiving percutaneous coronary intervention (PCI) [1]. Group 2: Regulatory Approvals and Milestones - In January 2019, the company received a drug registration certificate from the National Medical Products Administration (NMPA) for injectable bivalirudin [2]. - In May 2019, the company obtained a GMP certificate from the Hainan Provincial Drug Administration for the active pharmaceutical ingredient [2]. - In June 2019, the company successfully challenged the patent of the original holder of injectable bivalirudin [2]. - In October 2019, the ANDA for injectable bivalirudin received final approval from the FDA, leading to its market launch in the U.S. in 2020 [2]. - In December 2022, injectable bivalirudin passed the consistency evaluation for generic drug quality and efficacy by the NMPA [2]. - In February 2024, the product received registration approval from the Saudi Food and Drug Authority (SFDA) [2]. Group 3: Company Strategy and Product Portfolio - The company has extensive experience in the research, registration, production, and marketing of chemically synthesized peptide drugs, having developed multiple products including injectable thymosin alpha-1 and various other therapeutic drugs [3]. - The internationalization strategy aims to obtain drug approvals and market sales in developed countries such as the U.S. and EU to increase revenue and profit [3].

Group 1: New Stock Offerings - ST Xinchao (600777) has a tender offer period from April 23, 2025, to May 22, 2025[1] - Puli Tui (300630) has 7 trading days remaining until the last trading day[1] - ST Zhongcheng (300208) reported severe abnormal fluctuations[1] Group 2: Trading Alerts - Jintai (300225) and other stocks are under observation for trading alerts due to abnormal fluctuations[1] - ST Yida (600608) and ST Huke (600608) are also flagged for trading alerts[1] - Multiple stocks including ST Shengda (002259) and ST Yushun (002289) are under scrutiny for trading activities[1] Group 3: Recent Announcements - Guofang Group (601086) and other companies have made recent announcements regarding their stock activities[1] - A total of 7 trading days remain for several stocks approaching their last trading day[1] - Various companies including ST Huada (603580) and ST Aiai (603580) have made recent disclosures[1]

Group 1: Development Direction and Progress - The company focuses on high-end complex formulations, particularly in markets with large scale, high technical difficulty, and few competitors, to establish a unique competitive advantage [2][3] - Currently, the company has three peptide injection products (including APIs) approved for market in the U.S., with four more under FDA review [2] - The company aims to accelerate the registration process in Europe and expand into other global markets, leveraging approvals obtained in the U.S. [2] Group 2: Internationalization Efforts - The company has consistently pursued an internationalization strategy, successfully passing GMP inspections from the U.S. FDA, EU EMA, Philippines FDA, and Saudi Arabia SFDA [3] - Products such as thymosin alpha-1 and other injections have received FDA approval and have been exported to the U.S. [3] - The company plans to continue submitting DMF and ANDA applications in the U.S. and EU to further its internationalization efforts [3] Group 3: Raw Material Development - The company's thymosin alpha-1 has passed technical review by the Italian Medicines Agency (AIFA), and its somatostatin API has obtained a CEP certificate [3] - Other raw material businesses are being developed as a key focus for future growth [3] Group 4: Quality Management and CMO Cooperation - The subsidiary Ningbo Shuangcheng has passed the U.S. FDA CGMP inspection, ensuring compliance with quality management standards [3] - The company is actively pursuing CMO collaborations, particularly with major clients, while ensuring the production of its proprietary products [3]

Group 1 - The company will participate in the "2024 Annual Performance Briefing and Investor Reception Day" on May 13, 2025, to enhance communication with investors regarding its annual report and other key topics [1] - The company has received marketing authorization from the Therapeutic Goods Administration (TGA) in Australia for its injectable drug Bivalirudin, which is indicated as an anticoagulant for high-risk acute coronary syndrome patients [3][4] - The injectable Bivalirudin has previously received approvals from various regulatory bodies, including the FDA in the United States and the Saudi Arabian SFDA [5] Group 2 - The company's stock has experienced abnormal trading fluctuations, with a cumulative price deviation exceeding 12% over two consecutive trading days [9] - The company has confirmed that there are no undisclosed significant matters that could affect its stock price, and it has conducted a thorough review of its recent trading activity [10][11] - The company has been placed under a delisting risk warning due to negative financial results, with the lowest of its audited profit total, net profit, and net profit after non-recurring gains and losses being negative, and revenue below 300 million [12]

Group 1 - Ningde Times announced a share buyback plan with a total fund of 40 billion to 80 billion yuan, having repurchased 6.641 million shares, accounting for 0.1508% of the total share capital, with a total expenditure of 1.551 billion yuan [1] - Guoxin Technology successfully tested its quantum-resistant password chip AHC001, which is based on a domestic 28nm process and features low power consumption and high security, aimed at high-security applications [2] - Jingcheng Co. plans to introduce investors through a capital increase and share expansion for its subsidiary Tianhai Hydrogen Energy, with details yet to be determined [3] Group 2 - Weir Shares' shareholder plans to exchange up to 10 million shares for an open-ended index fund, representing 0.82% of the total share capital, aimed at optimizing asset allocation [4] - Zhejiang University Network New committed 33 million yuan to invest in a venture capital fund focusing on artificial intelligence and robotics, with a total target size of 100 million yuan [5] - Huayi Group intends to acquire 60% of San Aifu for 4.091 billion yuan to expand its business in fluorine fine chemicals, with funding sourced from its own or self-raised funds [6] Group 3 - Huina Technology's controlling shareholder is planning a change of control, leading to a temporary suspension of stock trading [7] - Tongyu Heavy Industry's actual controller will change from Zhuhai State-owned Assets Supervision and Administration Commission to Shandong State-owned Assets, following a share transfer agreement [8] - Kangxi Communication terminated its major asset restructuring plan and shifted to a strategic investment plan to acquire 35% of Shenzhen Chip Zhongxin Technology [9] Group 4 - Huafeng Measurement Control's shareholder plans to transfer 2.9% of its shares due to funding needs, with the transfer price set at a minimum of 70% of the average trading price over the previous 20 trading days [10] - Xiangyuan Cultural Tourism reported a 50.47% year-on-year increase in revenue during the May Day holiday [13] - Sairisi's April new energy vehicle sales increased by 12.99% year-on-year [13]