深圳翰宇药业股份有限公司 关于诉讼进展的公告 证券代码：300199 证券简称：翰宇药业 公告编号：2023-085 本公司及董事会全体成员保证信息披露的内容真实、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： 鉴于袁建成涉嫌职务犯罪一案已发回重审，公司将根据本案进展情况，及时履行 信息披露义务。敬请投资者注意投资风险。 2022 年 1 月 25 日，深圳翰宇药业股份有限公司（以下简称"翰宇药业"或"公 司"）发布《关于公司原董事、高级管理人员被采取刑事强制措施的公告》（公告编 号：2022-016），公司原董事、高级管理人员袁建成、朱文丰因涉嫌职务犯罪被公安 机关采取刑事强制措施的情况。 2023 年 1 月 18 日，公司发布《关于收到原董事、高级管理人员涉及刑事犯罪的 一审刑事判决书的公告》（公告编号：2023-007），公司原董事、高级管理人员袁建 成、朱文丰因涉嫌职务犯罪被广东省深圳市南山区人民法院一审判决。 近日，公司收到公司原董事、高级管理人员袁建成、朱文丰犯挪用资金罪的二审 刑事裁定书，相关信息如下： 一、案件基本情况 1、袁建成挪用资金案 2022 年 2 月 15 日 ...

药品名称：司美格鲁肽注射液 证券代码：300199 证券简称：翰宇药业 公告编号：2023-084 深圳翰宇药业股份有限公司 关于司美格鲁肽注射液临床试验注册申请获得受理的公告 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。 深圳翰宇药业股份有限公司（以下简称"公司"或"翰宇药业"）司美格鲁肽注 射液于2023年9月11日收到国家药品监督管理局签发的《受理通知书》（受理号： CXHL2300983、CXHL2300984）。现将有关具体情况公告如下： 一、药物基本情况 申请事项：境内生产药品注册临床试验 目前，全球司美格鲁肽尚无仿制药获批上市，仅诺和诺德公司一家在售。根据 诺和诺德公司2022年年度报告可知，司美格鲁肽注射液（Ozempic，降糖适应症）、 司美格鲁肽口服制剂（Rybelsus，降糖适应症）和司美格鲁肽注射液（Wegovy，减肥 适应症）2022年全球销售额分别约为593.32、112.2、61.45亿元人民币。根据PDB数 据库显示，2021年4月29日获批以来，我国司美格鲁肽的样本医院销售规模呈现快速 上升态势，2022年中国样本医院销售额 ...

深圳翰宇药业股份有限公司（以下简称"公司"或"翰宇药业"）控股股东、实际 控制人曾少贵先生累计质押公司股份数量为 127,290,000 股，占其所持公司股份数量 比例超过 80%。控股股东、实际控制人之一致行动人曾少强先生累计质押公司股份 数量为 79,500,000 股，占其所持公司股份数量比例超过 80%。控股股东、实际控制 人之一致行动人曾少彬先生累计质押公司股份数量为 21,500,000 股，占其所持公司 股份数量比例超过 80%。敬请投资者注意投资风险。 近日，翰宇药业接到控股股东、实际控制人曾少贵先生的通知，曾少贵先生办 理股票质押业务。现将有关情况公告如下： | 股东 | 是否为控 股股东或 | 质押股数 | 是否 | 质押开始日 | 质押解除 | | 占公司 | 本次质 押占其 | 用 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 名称 | 第一大股 | （股） | 为限 | 期 | 日期 | 质权人 | 总股本 | 所持股 | 途 | | | 东及其一 | | 售股 | | | | 比例 | 份比例 | ...

深圳翰宇药业股份有限公司 证券代码：300199 证券简称：翰宇药业 公告编号：2023-082 注册人：深圳翰宇医疗技术有限公司。 二、 产品的其他情况 关于全资子公司体外诊断试剂 获得医疗器械注册证的公告 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。 2023年9月5日，深圳翰宇药业股份有限公司(以下简称"公司"或"翰宇药业") 全 资子公司深圳翰宇医疗技术有限公司收到国家药品监督管理局颁发的《中华人民共 和国医疗器械注册证（体外诊断试剂）》（注册证编号：国械注准20233401282）， 现将具体内容公告如下： 一、批件基本信息 产品名称：新型冠状病毒(2019-nCoV) 抗原检测试剂盒（乳胶法）； 包装规格：1人份/盒、2人份/盒、5人份/盒、10人份/盒、20人份/盒、25人份/盒、 50人份/盒、75人份/盒、100人份/盒、200人份/盒； 注册证编号：国械注准20233401282； 有效期：5年（至2028年9月4日）； 本产品用于体外定性检测具有新型冠状病毒感染相关症状人群、其他需要进行 新型冠状病毒感染诊断人群鼻拭子样本中新型冠状病毒 ...

国浩律师（深圳）事务所 关于 深圳翰宇药业股份有限公司 二〇二三年第二次临时股东大会 的 北京·上海·深圳·杭州·广州·昆明·天津·成都·宁波·福州·西安·南京·南宁·济南·重庆 Beijing·Shanghai·Shenzhen·Hangzhou·Guangzhou·Kunming·Tianjin·Chengdu ·Ningbo ·Fuzhou·Xi`an·Nanjing·Nanning·Jinan·Chongqing 苏州·长沙·太原·武汉·贵阳·乌鲁木齐·郑州·石家庄·合肥·海南·青岛·南昌·大连·银川·拉孜 Suzhou·Changsha·Taiyuan·Wuhan ·Guiyang·Wulumuqi·Zhengzhou·Shijiazhuang·Hefei·Hainan·Qingdao·Nanchang·Dalian·Yinchuan·Lhatse 香港·巴黎·马德里·硅谷·斯德哥尔摩 Hongkong·Paris·Madrid·Silicon Valley·Stockholm 深圳市深南大道 6008 号特区报业大厦 24、31、41、42 层 邮编：518034 24、31、41、42F, Sp ...

证券代码：300199 证券简称：翰宇药业 公告编号：2023-081 深圳翰宇药业股份有限公司 2023年第二次临时股东大会决议公告 本公司及董事会全体成员保证信息披露内容的真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 2、本次股东大会不涉及变更前次股东大会决议。 一、会议召开和出席情况 1、2023年8月11日，深圳翰宇药业股份有限公司（以下简称"公司"或"翰宇 药业"）第五届董事会第十八次会议审议通过《关于提请召开2023年第二次临时 股 东 大 会 的 议 案 》 ， 详 见 公 司 在 中 国 证 监 会 指 定 信 息 披 露 网 站 （http://www.cninfo.com.cn）披露的相关公告。 2023年第二次临时股东大会召开的基本情况如下： 会议召集人：公司董事会 会议方式：本次会议采取现场投票和网络投票相结合的方式 会议召开时间：2023年8月30日（周三）下午15:30 会议地点：深圳市龙华区观澜高新园区观盛四路7号翰宇创新产业大楼会议 室 特别提示： 1、本次股东大会没有否决或变更议案的情况发生。 其中：通过现场投票的股东6人，代表股份235,991,981股，占上市 ...

证券代码：300199 证券简称：翰宇药业 公告编号：2023-080 深圳翰宇药业股份有限公司 关于控股股东、实际控制人及其一致行动人股份 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。 深圳翰宇药业股份有限公司（以下简称"公司"或"翰宇药业"）于 2023 年 2 月 14 日披露了《关于控股股东、实际控制人及其一致行动人股份减持计划预披露公告》， 控股股东、实际控制人曾少贵先生及其一致行动人曾少强先生、曾少彬先生合计持有本 公司股份 289,610,031 股（占本公司总股本比例 32.79%）计划自本公告披露之日起十五 个交易日后的六个月内采用集中竞价交易方式减持公司股份总量不超过 17,664,800 股 （占本公司总股本比例 2%）。 2023 年 8 月 29 日，公司收到曾少贵先生、曾少强先生及曾少彬先生出具的《关于 提前终止股份减持计划的告知函》，曾少贵先生、曾少强先生及曾少彬先生基于二级市 场形势及对公司未来的发展和价值判断，决定提前终止减持计划，未减持部分不再减持。 特此公告。 深圳翰宇药业股份有限公司董事会 2023年8月30日 1 减 ...

Environmental Compliance - The company reported a total discharge of 60.902 tons of hazardous waste in 2022, complying with national hazardous waste regulations[14]. - The company achieved a COD discharge of 0.57914 tons, meeting the standard of 300 mg/L[14]. - The company has a valid pollution discharge permit until April 25, 2027, following the renewal completed in March 2022[12]. - The company’s wastewater treatment processes consistently meet the discharge standards for various pollutants, including BOD at 4 mg/L and total nitrogen at 15 mg/L[14]. - The company’s wastewater discharge includes parameters such as pH between 6-9 and total phosphorus at 0.2 mg/L, all within regulatory limits[14]. - Shenzhen Hanyu Pharmaceutical Co., Ltd. achieved wastewater treatment compliance with BOD at 6.8 mg/L, below the limit of 150 mg/L, resulting in a total discharge of 0.00012 tons[15]. - The company reported a total phosphorus level of 0.33667 mg/L in treated wastewater, significantly below the 7 mg/L limit, with a total discharge of 1.13166 tons[15]. - The company processed 128.912 tons of hazardous waste in the Nanshan branch, adhering to national hazardous waste regulations[16]. - The company maintained compliance with wastewater discharge standards, with COD levels at 7.55716 mg/L, well below the 345 mg/L limit, resulting in a discharge of 0.03396 tons[16]. - The company’s noise levels were recorded at 58.4/48.4 mg/Nm3, compliant with the daytime and nighttime limits of 65/55 mg/Nm3[16]. - The company’s wastewater treatment facility is equipped with online monitoring for key indicators including COD, ammonia nitrogen, total nitrogen, total phosphorus, pH, and flow[18]. - The company’s wastewater treatment results consistently met standards, as confirmed by self-monitoring protocols[21]. - The company updated its emergency response plan for environmental incidents in August 2021, ensuring preparedness for potential environmental events[22]. - The company’s wastewater treatment process achieved compliance with ammonia nitrogen levels at 4.16371 mg/L, below the 35 mg/L limit, with a total discharge of 0.01871 tons[16]. - In the first half of 2023, the company invested over 3.43 million RMB in environmental protection expenses, including 1,567 RMB in environmental protection tax[35]. - The company invested 480,000 RMB in environmental protection measures and paid 2,139.76 RMB in environmental protection tax in the first half of 2023[23]. Corporate Governance and Financial Reporting - The half-year financial report has not been audited, indicating that the figures may be subject to change upon final review[47]. - The financial report emphasizes the commitment to accurate and complete financial disclosures, as stated by the company's management[115]. - The company continues to comply with regulatory requirements for financial reporting and disclosures[115]. - The report includes a comprehensive overview of the company's governance and social responsibility initiatives[117]. - The report is available for review at the company's securities management department[120]. - All directors attended the board meeting to review the semi-annual report[138]. Financial Performance - The company's operating revenue for the reporting period was ¥325,278,801.43, a decrease of 8.77% compared to the same period last year[137]. - The net profit attributable to shareholders was -¥34,133,703.88, an improvement of 65.25% from -¥98,223,075.25 in the previous year[137]. - The net profit attributable to shareholders after deducting non-recurring gains and losses was -¥106,372,963.05, a decline of 257.26% compared to -¥29,774,600.47 last year[137]. - The net cash flow from operating activities was -¥37,660,161.00, a significant decrease of 220.82% from ¥31,170,243.64 in the previous year[137]. - The total assets at the end of the reporting period were ¥3,495,397,141.24, down 3.21% from ¥3,611,233,247.62 at the end of the previous year[137]. - The net assets attributable to shareholders at the end of the reporting period were ¥1,261,019,876.94, a decrease of 0.76% from ¥1,270,636,709.44 at the end of the previous year[137]. - The basic and diluted earnings per share were both -¥0.04, an improvement of 63.64% from -¥0.11 in the same period last year[137]. - The weighted average return on equity was -2.70%, an improvement of 3.59% from -6.29% in the previous year[137]. - The company plans not to distribute cash dividends or issue bonus shares[139]. Market Position and Product Development - The company operates in the pharmaceutical manufacturing industry, which is characterized by weak cyclicality and is expected to see continued growth due to increasing healthcare demand driven by factors such as aging population and rising disposable income[37]. - The company specializes in peptide drug research, production, and sales, leveraging advanced automated peptide synthesis and purification systems to maintain a competitive edge in both domestic and international markets[38]. - The main products include peptide raw materials and formulations, with a strategic focus on four therapeutic areas: reproductive health, digestive bleeding, weight loss, and infection control[39]. - The company holds a 76.78% market share in the domestic market for its injection of terlipressin, which is recommended as a first-line treatment for complications related to liver cirrhosis[44]. - The company has developed a comprehensive range of injectable products, including somatostatin and terlipressin, which are recognized in various clinical guidelines for their effectiveness in treating specific medical conditions[43][44]. - The company aims to optimize its product structure and enhance strategic resilience to maintain its leading position in the peptide drug industry[38]. - The company has 26 peptide drugs, 9 new drug certificates, and 24 clinical approvals, indicating a strong product pipeline[178]. - The company achieved a significant market share in domestic peptide drugs, particularly in products like Liraglutide and Semaglutide, which are recognized internationally for their high technical difficulty[179]. - The company has passed or deemed to have passed consistency evaluations for 15 generic drugs, including 10 peptide injections and 5 small molecule solid preparations, leading the industry in evaluation numbers[179]. - The company continues to advance its product registration in both domestic and international markets, with the approval of Acetate Octreotide Injection in January 2023[182]. - The company is actively pursuing strategic partnerships to enhance its international market presence and product offerings[176]. - The company has established a comprehensive R&D platform, collaborating with various research institutions to support its innovative drug development[177]. - The company is focused on expanding its market strategy by leveraging its product quality and technological advantages[176]. - The company aims to maintain a competitive edge through continuous product development and strategic partnerships[195]. Shareholder and Capital Management - The company approved the cancellation of 33,685,704 repurchased shares, reducing total share capital from 916,927,040 shares to 883,241,336 shares[88]. - The company completed the business registration change and obtained a new business license on April 17, 2023, following the share cancellation[98]. - The total amount of external guarantees approved during the reporting period is 0, while the actual amount of guarantees provided is 12,500,000 yuan, with a total guarantee balance of 42,700,000 yuan at the end of the reporting period[78]. - The actual total amount of guarantees provided accounts for 95.24% of the company's net assets[80]. - The company has not reported any non-compliance issues regarding external guarantees during the reporting period[46]. - There are no significant related party transactions or major contracts during the reporting period[81]. - The company has not engaged in any asset or equity acquisitions or sales during the reporting period[68]. - The company has no significant litigation cases that meet the materiality standards during the reporting period[65]. - The company has not conducted any joint external investments during the reporting period[69]. - The company has no significant leasing situations during the reporting period[75]. - The company has no significant related party debts or financial transactions with related financial companies[70]. - The company has no other major related transactions during the reporting period[73]. - The company has not issued new shares or conducted stock splits during this reporting period[107]. Product Quality and Certifications - The company has achieved multiple certifications, including FDA and EU GMP, ensuring high-quality management standards[195]. - The company has obtained the EU GMP certification for its injection production line, which allows its products to continue entering the EU market, positively impacting future operating performance[83]. - The production model is based on "sales-driven production + minimal stock," ensuring timely delivery and quality control through various GMP certifications[189]. - The marketing structure has been optimized to enhance efficiency and coverage in various regional markets[195]. - The company emphasizes a comprehensive quality management system, ensuring 100% compliance with production standards and training[195]. - The company launched upgraded peptide skincare products under the brand "Boshuyan" and successfully marketed antibacterial agents "Hanqu" and "Hanf" through various online platforms[106]. - The company is focusing on expanding its product offerings based on market needs, leveraging its technological advantages in the peptide industry[106].

采取监管措施或处罚及整改情况的公告 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。 深圳翰宇药业股份有限公司（以下简称"公司"或"翰宇药业"）第五届董事 会第十八次会议、第五届监事会第十三次会议审议通过了关于公司2023年度向特定 对象发行A股股票的相关议案。公司对近五年是否被证券监管部门和证券交易所采 取监管措施或处罚的情况进行了自查，自查结果如下： 一、最近五年被证券监管部门和交易所采取处罚的情况 （一）公司最近五年不存在被证券监管部门和交易所处罚的情况。 证券代码：300199 证券简称：翰宇药业 公告编号：2023-075 深圳翰宇药业股份有限公司 关于最近五年被证券监管部门和证券交易所 （二）公司最近五年被证券交易所纪律处分的情况如下： 1、2019年9月18日深圳证券交易所出具的《关于对深圳翰宇药业股份有限公司 及相关当事人给予通报批评处分的决定》 公司于2019年9月18日收到深圳证券交易所出具的《关于对深圳翰宇药业股份有 限公司及相关当事人给予通报批评处分的决定》，公司因2018年度业绩预告披露的 预计净利润与2018年年度报告经审计的净利润存 ...

深圳翰宇药业股份有限公司 关于 2023 年度以简易程序向特定对象发行股票预案 披露的提示性公告 证券代码：300199 证券简称：翰宇药业 公告编号：2023-074 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。 深圳翰宇药业股份有限公司董事会 2023 年 8 月 15 日 深圳翰宇药业股份有限公司于 2023 年 8 月 11 日召开了第五届董事会第十八次 会议和第五届监事会第十三次会议，会议审议通过了关于 2023 年度以简易程序向特 定对象发行股票的相关议案。《深圳翰宇药业股份有限公司 2023 年度以简易程序向 特定对象发行股票预案》（以下简称"预案"）及相关公告已于同日在中国证监会 指定的创业板信息披露网站巨潮资讯网（http://www.cninfo.com.cn）上披露，敬请广 大投资者注意查阅。 该预案披露事项不代表审核机关对于本次以简易程序向特定对象发行股票相关 事项的实质性判断、确认或批准，预案所述本次发行股票相关事项的生效和完成尚 需获得深圳证券交易所审核通过和中国证券监督管理委员会的同意注册，敬请广大 投资者注意投资风险。 特此公 ...