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]

证券代码：002693 证券简称：*ST双成 公告编号：2025-032 海南双成药业股份有限公司 关于参加"2024 年度海南辖区上市公司业绩说明会暨投资 者集体接待日"的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚 假记载、误导性陈述或重大遗漏。 为推动辖区上市公司进一步建立董事会与投资者的良好沟通机制，让投资者 更准确地读懂年度报告、更全面地了解上市公司，切实提高上市公司透明度和治 理水平，海南证监局将与深圳市全景网络有限公司、海南上市公司协会联合举办 "2024 年度海南辖区上市公司业绩说明会暨投资者集体接待日"活动，活动时 间为 2025 年 5 月 13 日 14:00-17:00，平台登陆地址为：https://rs.p5w.net。 届时，海南双成药业股份有限公司主要高管人员将参加本次活动，通过网络 在线交流形式，就公司 2024 年年报披露、财务数据、公司治理、内部控制、发 展战略、经营状况、现金分红、重大事项、可持续发展等投资者所关心的问题， 与投资者进行"一对多"形式的沟通与交流。欢迎广大投资者踊跃参与。 特此公告。 海南双成药业股份有限公司董事会 2025 年 ...

上市许可的公告 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。 海南双成药业股份有限公司（以下简称"公司"） 于近日收到澳大利亚药 物管理局（TGA）签发的注射用比伐芦定的上市许可，现将相关情况公告如下： 一、药品基本情况 1、药品商品名：注射用比伐芦定 2、剂型：注射剂 证券代码：002693 证券简称：*ST双成 公告编号：2025-033 海南双成药业股份有限公司 关于注射用比伐芦定获得澳大利亚药物管理局（TGA） 3、规格：250mg 三、对公司的影响及风险提示 本次注射用比伐芦定获得澳大利亚药物管理局签发的上市许可，表明公司注 射用比伐芦定具备了在澳大利亚进行销售的资质。对公司拓展海外市场、提升公 司业绩带来积极的影响。由于药品出口业务容易受到市场需求变化、政策环境变 化、汇率波动、市场竞争等因素的影响，上述产品在澳大利亚市场销售的时间、 市场规模、后续拓展进度具有不确定性。敬请广大投资者理性投资，注意防范投 资风险。 特此公告！ 海南双成药业股份有限公司董事会 2025 年 5 月 7 日 4、适应症：注射用比伐芦定用作抗凝剂。治疗中高风险急性冠状 ...

Core Viewpoint - The company *ST Shuangcheng (002693.SZ)* has received marketing approval from the Australian Therapeutic Goods Administration for its injectable drug, Bivalirudin, which is used to treat patients with moderate to high-risk acute coronary syndrome (ACS) [1] Group 1: Regulatory Approvals - The drug has previously received a drug registration certificate from the National Medical Products Administration (NMPA) in China [1] - The company has also passed the consistency evaluation of quality and efficacy for injectable generic drugs by the NMPA [1] Group 2: Market Impact - The approval in Australia is expected to positively impact the company's efforts to expand into overseas markets and enhance its performance [1] - However, the drug export business is subject to various factors, leading to uncertainties regarding sales timelines, market size, and future expansion progress [1]

Summary of Key Points Core Viewpoints - The report highlights the ongoing trend of stock suspensions due to delisting risk warnings across multiple companies, indicating a potential downturn in market confidence and stability [2][3][4]. Company Listings - Several companies are scheduled for initial public offerings (IPOs) on April 29, 2025, including Tai Li Technology (301595) and Ze Run New Energy (301636), which may attract investor interest [1]. - The report notes the specific dates for various IPO-related activities, such as inquiry periods and fund unfreezing dates, which are crucial for market participants [1]. Stock Suspension Announcements - Numerous companies, including Guohua Network Security (000004) and Nanhua Biology (000504), have announced stock suspensions due to delisting risk warnings, reflecting a significant concern regarding their financial health [2][3]. - The report lists a total of 30 companies facing stock suspensions on April 29, 2025, due to various risk warnings, which may impact investor sentiment and trading volumes [2][3][4]. Special Suspensions - Companies like *ST Xu Lan (000040) and *ST Gong Zhi (000584) are highlighted for potential termination of listings, indicating severe financial distress and regulatory scrutiny [4][5]. - The report emphasizes the importance of monitoring these companies as their situations evolve, which could present both risks and opportunities for investors [4][5].