证券代码：002693 证券简称：*ST双成 公告编号：2025-038 海南双成药业股份有限公司 股票交易异常波动及风险提示性公告 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。 重要风险提示： 证券代码：002693）股票交易价格于 2025 年 5 月 20 日、2025 年 5 月 21 日及 2025 年 5 月 22 日连续三个交易日收盘价格涨幅偏离值累计超过 12%。根据深圳证券 交易所的有关规定，属于股票交易异常波动的情况。 二、公司关注并核实相关情况 针对公司股票异常波动，公司对有关事项进行了核查，并问询了公司控股股 东及实际控制人，有关情况说明如下： 1、前期披露的信息不存在需要更正、补充之处。 2、公司未发现近期公共传媒报道可能或已对公司股票交易价格产生较大影 响的未公开重大信息。 1、公司于 2025 年 4 月 29 日披露了《关于公司股票被实施退市风险警示暨 停牌的公告》（公告编号：2025-028），因公司 2024 年度经审计的利润总额、净 利润、扣除非经常性损益后的净利润三者孰低者为负值，且扣除后的营业收入低 于 3 亿元，公 ...

证券代码：002693 证券简称：*ST双成 公告编号：2025-037 海南双成药业股份有限公司 股票交易异常波动及风险提示性公告 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。 重要风险提示： 1、公司于 2025 年 4 月 29 日披露了《关于公司股票被实施退市风险警示暨 停牌的公告》（公告编号：2025-028），因公司 2024 年度经审计的利润总额、净 利润、扣除非经常性损益后的净利润三者孰低者为负值，且扣除后的营业收入低 于 3 亿元，公司股票交易被深圳证券交易所实施退市风险警示。敬请广大投资者 注意投资风险。 2、股票异常波动风险 公司分别于 2025 年 4 月 15 日、2025 年 4 月 17 日、2025 年 4 月 23 日、2025 年 5 月 7 日披露《股票交易异常波动及风险提示性公告》（公告编号：2025-015、 2025-016、2025-018、2025-034）。公司股票收盘价格涨跌幅偏离值累计达到深 圳证券交易所的有关规定属于股票交易异常波动情况。近期，公司股票交易价格 发生较大波动，敬请广大投资者注意二级市场交 ...

证券代码：002693 证券简称：*ST双成 公告编号：2025-036 关于依替巴肽注射液获得澳大利亚药物管理局（TGA） 上市许可的公告 海南双成药业股份有限公司 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）签发的依替巴肽注射液的上市许可，现将相关情况公告如下： 特此公告！ 海南双成药业股份有限公司董事会 4、获批适应症：适用于接受非紧急经皮冠状动脉介入治疗并进行冠状动脉 内支架植入的患者；适用于治疗不稳定性心绞痛或非 Q 波型心肌梗死患者。 二、药品相关的其他情况 依替巴肽注射液原研药商品名为 Integrilin®，厂家为 Schering Corp，于 1998 年 5 月 18 日获美国 FDA 的上市批准；目前已在全球广泛销售。 公司产品依替巴肽注射液小规格（20mg/10mL）和大规格（75mg/100mL)分别 通过美国 FDA 上市许可批准。详见 2021 年 9 月 10 日披露的《关于依替巴肽注射 液 ANDA 获得美国 FDA 上市许可的公告》（ ...

Core Viewpoint - The company *ST Shuangcheng (002693)* has received marketing approval for Eptifibatide injection from the Australian Therapeutic Goods Administration, which is expected to enhance its overseas market expansion and improve performance [1] Group 1: Product Approval - Eptifibatide injection is indicated for patients undergoing non-emergency percutaneous coronary intervention and coronary artery stenting, as well as for treating unstable angina or non-Q-wave myocardial infarction [1] - The product has already received marketing approval from the US FDA and is widely sold globally [1] Group 2: Market Impact - The approval in Australia will assist the company in expanding its overseas market presence [1] - The company cautions that export sales of the drug may be influenced by market demand, policy environment, exchange rates, and market competition, indicating potential uncertainties [1]

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: 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]

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: 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]