的公告 证券代码：002693 证券简称：双成药业 公告编号：2024-028 海南双成药业股份有限公司 关于醋酸奥曲肽注射液 ANDA 获得美国 FDA 上市许可 2024 年 2 月，公司产品醋酸奥曲肽注射液获得中国国家药品监督管理局批 准签发的《药品注册证书》，该产品获批视同其通过一致性评价。具体内容详见 2024 年 3 月 4 日巨潮资讯网公告，公告编号：2024-008。 三、对公司的影响 公司醋酸奥曲肽注射液 ANDA 通过美国 FDA 上市许可批准，标志着公司生产 的醋酸奥曲肽注射液在安全性和有效性上达到了原研水平，将进一步推进公司国 际化布局的进程，提升公司产品的国际影响力，对公司未来经营业绩具有积极的 影响，也为公司后续药品研发与国际化上市申请工作积累了非常宝贵的经验。 四、风险提示 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 提交的醋酸奥曲肽 注射液简化新药申请（以下简称"ANDA"）已获得美国 FDA 的 ...

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 "2023 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 2023 年 5 月 14 日 14:00-17:00，平台登陆地址为：http://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 2023 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。 证券代码：002693 证券简称：双成药业 公告编号：2024-027 海南双成药业股份有限公司 关于参加"2023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。 海南双成药业股份有限公司董事会 2024 年 4 ...

Financial Performance - The company's operating revenue for 2023 was approximately ¥235.93 million, a decrease of 14.13% compared to ¥274.75 million in 2022[23]. - The net profit attributable to shareholders for 2023 was a loss of approximately ¥50.74 million, representing a decline of 663.02% from a profit of ¥9.01 million in 2022[23]. - The net cash flow from operating activities decreased by 53.84% to approximately ¥11.64 million in 2023, down from ¥25.22 million in 2022[23]. - The total assets at the end of 2023 were approximately ¥803.25 million, a decrease of 11.83% from ¥911.02 million at the end of 2022[23]. - The net assets attributable to shareholders decreased by 8.19% to approximately ¥471.49 million at the end of 2023, down from ¥513.55 million at the end of 2022[23]. - The basic earnings per share for 2023 was -¥0.12, a decline of 700.00% compared to ¥0.02 in 2022[23]. - The weighted average return on net assets was -10.24% in 2023, a decrease of 12.04% from 1.80% in 2022[23]. - The company reported a net profit excluding non-recurring gains and losses of approximately -¥24.14 million, an improvement of 34.55% from -¥36.88 million in 2022[23]. Revenue and Sales Trends - In the first quarter, the company's operating revenue was ¥81,485,154.92, while in the third quarter, it dropped to ¥43,235,465.80, indicating a significant decline[28]. - The net profit attributable to shareholders was negative in the third and fourth quarters, with losses of ¥10,410,823.84 and ¥49,121,010.96 respectively[28]. - The total non-recurring losses for 2023 amounted to ¥26,601,267.28, a significant decrease from the previous year's non-recurring gains of ¥45,893,461.68[29]. - The peptide product line generated CNY 113.16 million in revenue, a decrease of 4.02% year-on-year[57]. - The company reported a gross margin of 70.34% for peptide products, an increase of 8.36% compared to the previous year[59]. Research and Development - The company is recognized as a national high-tech enterprise, focusing on the research and development of peptide drugs, with multiple products approved and sold in developed countries[38]. - The company has established a comprehensive technical system for the synthesis, purification, analysis, and quality assurance of chemical synthetic peptide drugs[39]. - The company has developed multiple chemical synthetic peptide drugs and 20 other therapeutic drugs, with key products including Thymosin Alpha 1 and Somatostatin injection[44]. - The company is actively involved in the development of new products and technologies, particularly in the field of peptide drugs, which positions it well for future market expansion[39]. - Research and development expenses amounted to CNY 34.11 million, representing 14.46% of operating revenue[51]. - R&D investment amounted to ¥34,110,034.71 in 2023, down 8.35% from ¥37,216,294.81 in 2022, while the proportion of R&D investment to operating revenue rose to 14.46% from 13.55%[70]. Regulatory Compliance and Quality Control - The company has successfully passed GMP inspections from the FDA, EU, Philippines, and Saudi Arabia, indicating compliance with international standards[38]. - The company emphasizes strict quality control in drug production to mitigate risks related to drug safety and compliance with regulations[104]. - The company has established a comprehensive pollution management system to comply with environmental regulations and reduce risks associated with waste emissions[104]. - The company has conducted a soil pollution risk assessment and submitted the report to the local environmental authority in November 2023[174]. - The company has successfully renewed its pollutant discharge permit, valid from February 24, 2023, to February 23, 2028[173]. Market and Competitive Landscape - The pharmaceutical manufacturing industry in China saw a revenue decline of 3.7% in 2023, with total profits down by 15.1% compared to the previous year[32]. - The domestic peptide drug market is experiencing annual sales growth, with increasing recognition of chemical synthetic peptide drugs due to their safety and efficacy[92]. - The company aims to enhance its internationalization strategy by synchronously applying for domestic and international approvals for new products, leveraging its GMP-certified facilities[96]. - The company is focusing on developing new technologies and processes to reduce production costs and environmental impact[98]. - The company is committed to increasing R&D investment, particularly in peptide drug development, to maintain competitiveness and meet international standards[96]. Risk Management - The company faces various risks including policy changes, price fluctuations of raw materials, and potential impacts from public health events[4]. - Financial risks are being managed through enhanced internal controls and strategies to mitigate foreign exchange risks associated with increasing export activities[106]. - The company is prepared to adapt its operations in response to potential impacts from public health events on the macro economy and supply chain[106]. Corporate Governance - The company held a total of 4 shareholder meetings during the reporting period, all convened by the board of directors, ensuring compliance with legal and regulatory requirements[111]. - The board of directors consists of 6 members, including 2 independent directors, and held 9 meetings during the reporting period[112]. - The company has established a performance evaluation system for directors and senior management, promoting transparency and accountability in its operations[114]. - The company has implemented an internal audit system with 2 auditors to oversee financial statements and internal controls[115]. - The company operates independently from its controlling shareholders in terms of business, personnel, assets, institutions, and finance, ensuring complete operational autonomy[116]. Employee and Management Structure - The total number of employees at the end of the reporting period is 474, with 375 from the parent company and 99 from major subsidiaries[148]. - The professional composition includes 194 production personnel, 25 sales personnel, 165 technical personnel, 11 financial personnel, 65 administrative personnel, and 14 material personnel[148]. - The company has a total of 15 current senior management members, with varying remuneration levels[138]. - The company has appointed several new deputy general managers, including Yao Zhong, Wang Shiyin, Ai Yixiang, Li Haiyan, Wang Rui, and Li Yuan, all effective from January 9, 2023[122]. Environmental Responsibility - Environmental protection investments totaled approximately CNY 3.27 million, with upgrades to wastewater treatment facilities to enhance pollutant management[53]. - The company has not faced any administrative penalties related to environmental issues during the reporting period[180]. - The company is committed to fulfilling its social responsibility while pursuing its own development[181]. Shareholder Commitments - The company plans to implement a cash dividend policy, prioritizing cash dividends and aiming for a minimum of 30% of the average distributable profit over the past three years for cash distributions from 2024 to 2026[189]. - The company guarantees that it and its related parties will not engage in related transactions with Shuangcheng Pharmaceutical unless unavoidable, adhering to legal and regulatory requirements[185]. - The commitments made by the company and its related parties are intended to protect the legitimate rights of other shareholders of Shuangcheng Pharmaceutical[185].

Financial Performance - The company's operating revenue for Q1 2024 was ¥42,761,740.63, a decrease of 47.52% compared to the same period last year[3]. - The net profit attributable to shareholders was a loss of ¥8,742,676.77, representing a decline of 294.04% year-on-year[3]. - The net cash flow from operating activities was a negative ¥23,640,127.59, which is an 18.91% increase in cash outflow compared to the previous year[3]. - The basic earnings per share were -¥0.0211, down 291.82% from the same period last year[3]. - The company's net loss for Q1 2024 was not explicitly stated, but retained earnings decreased to CNY -355,701,958.88 from CNY -346,959,282.11[23]. - The operating profit for Q1 2024 was -14,178,627.36 CNY, down from 120,989.11 CNY in Q1 2023[26]. - The company reported a total comprehensive income of -14,193,507.24 CNY for Q1 2024, compared to 104,982.11 CNY in the same period last year[26]. - The basic and diluted earnings per share for Q1 2024 were both -0.0211 CNY, compared to 0.0110 CNY in Q1 2023[26]. Assets and Liabilities - The total assets at the end of the reporting period were ¥798,456,832.58, a decrease of 0.60% from the end of the previous year[3]. - Non-current assets totaled CNY 667,355,536.99, slightly down from CNY 668,012,248.28, a decrease of 0.1%[22]. - Total liabilities increased to CNY 294,772,489.85 from CNY 285,602,524.16, marking a rise of 3.9%[23]. Cash Flow and Investments - The company's cash and cash equivalents increased by 1731.23% year-on-year, primarily due to changes in operating, investing, and financing activities[10]. - Total cash and cash equivalents at the end of Q1 2024 amounted to 17,684,279.51 CNY, an increase from 5,920,315.43 CNY at the end of Q1 2023[29]. - Cash inflow from investment activities was 46,581,555.73 CNY, down from 150,408,649.83 CNY in the previous year[28]. - Cash inflow from financing activities was 25,931,612.24 CNY, significantly higher than 4,392,700.00 CNY in Q1 2023[28]. Sales and Expenses - Sales revenue from goods and services decreased by 41.88% year-on-year, attributed to a decline in drug sales and prices[9]. - The company reported a significant reduction in sales expenses, which fell to CNY 14,600,389.33 from CNY 37,202,576.52, a decrease of 60.7%[24]. - The company achieved a 483.08% increase in cash received from borrowings compared to the previous year, due to new bank loans[10]. - Research and development expenses increased to CNY 3,041,458.97 from CNY 2,589,268.35, representing an increase of 17.4%[24]. Shareholder Information - The total number of common shareholders at the end of the reporting period is 39,723[12]. - Hainan Shuangcheng Investment Co., Ltd. holds 32.75% of shares, totaling 136,516,546 shares, with 32,000,000 shares pledged[12]. - HSP Investment Holdings Limited holds 15.50% of shares, totaling 64,599,379 shares, with 16,210,000 shares pledged[12]. - The company completed the second exercise period of its stock option plan, increasing total share capital from 414,737,000 shares to 416,789,750 shares[15]. Regulatory Approvals and Product Development - The company has received drug registration approvals for several products, including Thymosin Injection in Pakistan and Acetate Liraglutide Injection in China[17][19]. - The company’s subsidiary, Ningbo Shuangcheng, passed the FDA CGMP pre-approval inspection[17]. - The company’s product, Pregabalin Capsules, received drug registration approval from the National Medical Products Administration[19]. Stock Options and Incentives - The company plans to implement a stock option and restricted stock incentive plan, with 205,275 stock options and 210,000 restricted stocks being exercised or released[15][17]. - The company has 75 individuals eligible for stock options in the current exercise period, with the exercise period running from May 8, 2023, to May 3, 2024[15]. - The company’s stock option plan has seen some options canceled due to performance targets not being met, totaling 205,275 options[16].

证券代码：002693 证券简称：双成药业 公告编号：2024-026 海南双成药业股份有限公司 关于举办2023年度网上业绩说明会的公告 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。 海南双成药业股份有限公司（以下简称"公司"）于 2024 年 4 月 30 日在巨 潮资讯网上披露了《2023 年年度报告》及《2023 年年度报告摘要》。为便于广 大投资者更加全面深入地了解公司经营业绩、发展战略等情况，公司定于 2024 年 05 月 13 日（星期一）15:00-17:00 在"价值在线"（www.ir-online.cn）举 办海南双成药业股份有限公司 2023 年度网上业绩说明会，与投资者进行沟通和 交流，广泛听取投资者的意见和建议。 投资者可于 2024 年 05 月 13 日（星期一）15:00-17:00 通过以下方式参与 本次业绩说明会： ① 登录深圳证券交易所"互动易"平台（http://irm.cninfo.com.cn）， 进入"云访谈"栏目参与互动交流； ② 通过网址 https://eseb.cn/1dkgR6BJc5O 或使用微信 ...

证券代码：002693 证券简称：双成药业 公告编号：2024-013 海南双成药业股份有限公司 关于公司通过美国 FDA 现场检查的公告 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 2024 年 1 月 18 日至 2024 年 1 月 26 日接受了美国食品药品监督管理局（以下简称"FDA"）的 CGMP（现行 药品生产质量管理规范）现场检查，检查范围为冻干粉针剂三车间、注射液一车 间大容量生产线、原料药二车间。 公司于近日收到 FDA 的通知，按照美国 21CFR 法规，FDA 确认该检查已结束， 并提供本次现场检查报告(EIR)。该通知和检查报告已明确公司通过了此次美国 FDA CGMP 检查，公司的质量管理体系符合美国 FDA CGMP 的要求。 美国 CGMP 是国际医药行业公认的最高标准的药品质量管理规范和生产质量 管理体系。公司及控股子公司近年来已多次顺利通过美国 FDA CGMP 现场检查， 证明公司的质量体系稳定可靠。良好的质量体系是公司长期坚持国际化战略的结 果，为公司的产品质量和国际市 ...

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"）于近日收到国家药品监督 管理局批准签发的"注射用硼替佐米"《药品注册证书》，证书编号为 2024S00518。 现将相关信息公告如下： 一、药品基本情况 1、药品名称：注射用硼替佐米（英文名/拉丁名：Bortezomib for Injection） 2、主要成分：硼替佐米 3、剂型：注射剂 4、申请事项：药品注册(境内生产) 5、规格：3.5mg 6、注册分类：化学药品 4 类 7、药品注册标准编号：YBH04462024 8、药品有效期：24 个月 9、包装规格：1 瓶/盒；10 瓶/盒 10、处方药/非处方药：处方药 11、上市许可持有人：海南双成药业股份有限公司 12 上市许可持有人地址：海口市秀英区兴国路 16 号 13、生产企业：宁波双成药业有限公司 14、生产地址：浙江省宁波市杭州湾新区滨海四路 866 号 15、药品批准文号：国药准字 H20243439 16、药品批准文号有效期：至 2029 年 04 月 06 日 17、审批结论：根据《中华人民共和国 ...

证券代码：002693 证券简称：双成药业 公告编号：2024-011 普瑞巴林是神经递质γ-氨基丁酸（GABA）的一种类似物，为加巴喷丁的 后续产品。目前，普瑞巴林胶囊已被美国食品和药品监督管理局（FDA）批准用 于与糖尿病周围神经病变（DPN）有关的神经性疼痛、带状疱疹后神经痛（PHN）、 部分发作性癫痫 1 个月及以上患者的辅助治疗、肌纤维痛和与脊髓损伤相关的神 经性疼痛；普瑞巴林胶囊已被国家药品监督管理局批准用于带状疱疹后神经痛和 纤维肌痛。 普瑞巴林胶囊被纳入国家医保（2023 年版）乙类药品目录，并被列入基药 目录（2018 版）。 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"）控股子公司宁波双成药业 有限公司（以下简称"宁波双成"）于近日收到国家药品监督管理局批准签发的 普瑞巴林胶囊（规格：75mg、300mg）《药品注册证书》，证书编号：2024S00391、 2024S00392。现将相关信息公告如下： 一、药品基本情况 1、药品名称：普瑞巴林胶囊（英文名/拉丁名：Pregabalin Capsu ...

证券代码：002693 证券简称：双成药业 公告编号：2024-010 海南双成药业股份有限公司 关于注射用比伐芦定获得沙特阿拉伯SFDA注册批件的公告 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"）于近日收到沙特阿拉伯食 品药品监督管理局（以下简称"SFDA"）核准签发的注射用比伐芦定注册批件， 证书编号为 0000023814。现将相关信息公告如下： 一、药品基本情况 1、产品商品名：注射用比伐芦定 二、药品相关的其他情况 比伐芦定是一种作用可逆的特异性凝血酶抑制剂。注射用比伐芦定的适应症 是作为抗凝剂用于成人经皮冠状动脉腔内成形术（PTCA）和经皮冠状动脉介入治 疗（PCI），以及用于 PCI 中有由肝素引起血小板减少（HIT）或有由肝素引起血 小板减少和血栓综合症（HITTS）风险的病人。 2019 年 1 月，公司获得国家药品监督管理局批准签发的注射用比伐芦定《药 品注册批件》；2019 年 5 月，公司收到海南省药品监督管理局颁发的《药品 GMP 证书》,原料药比伐芦定获得 GMP 认证；2019 年 ...

证券代码：002693 证券简称：双成药业 公告编号：2024-009 海南双成药业股份有限公司 关于控股子公司药品生产许可证变更的公告 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"）的控股子公司宁波双 成药业有限公司（以下简称"宁波双成"）于近日取得浙江省药品监督管理 局换发的《药品生产许可证》。本次变更主要涉及受托公司的生产品种 SC－ C134 受托生产有效期延长至 2027 年 11 月 13 日。现将有关情况公告如下： 企业名称：宁波双成药业有限公司 社会信用代码：91330201309097023A 注册地址：浙江省宁波杭州湾新区滨海四路 866 号 法定代表人：WANG YINGPU 企业负责人：姚忠 质量负责人：张文超 有效期至：2027 年 11 月 13 日 许可证编号：浙 20180007 分类码：AhCh 生产地址和生产范围：浙江省宁波市杭州湾新区滨海四路 866 号；冻干 粉针剂（抗肿瘤药）、片剂、胶囊剂、*** 本次宁波双成《药品生产许可证》变更主要系受托生产公司的药品有效 期延长，不会 ...