证券代码：300199 证券简称：翰宇药业 公告编号：2024-031 深圳翰宇药业股份有限公司 2023年年度股东大会决议公告 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。 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。 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、2024年4月25日，深圳翰宇药业股份有限公司（以下简称"公司"或"翰 宇药业"）第五届董事会第二十四次会议审议通过《关于提请召开2023年年度股 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年年度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 会议主持人：董事长曾少贵先生 本次会议的召集、召开符合《公司法》《上市公司股东大会规则》以及《公 司章程》《股东大会议事规则》等的有关规定，合法有 ...

法律意见书 国浩律师（深圳）事务所 关于 深圳翰宇药业股份有限公司 二〇二三年度股东大会 的 法律意见书 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、4 ...

Financial Performance - Net profit attributable to shareholders decreased by 38.68% year-on-year in 2023, primarily due to significant price reductions of key products entering centralized procurement and delayed international business contracts contributing minimally to 2023 profits[7] - Quarterly revenue declined from 176,222,802.86 in Q1 to 29,828,864.39 in Q4, with net profit turning from 18,605,574.69 in Q1 to -333,326,785.70 in Q4[13] - Revenue in 2023 decreased by 38.75% to 431,384,112.87 yuan compared to 704,321,731.88 yuan in 2022[65] - Net profit attributable to shareholders in 2023 was -513,876,149.69 yuan, a decrease of 38.68% from -370,550,318.41 yuan in 2022[65] - Operating cash flow in 2023 was -3,536,573.51 yuan, a decrease of 122.37% from 15,807,431.54 yuan in 2022[66] - Total assets at the end of 2023 decreased by 9.25% to 3,277,193,711.56 yuan from 3,611,233,247.62 yuan at the end of 2022[66] - Net assets attributable to shareholders at the end of 2023 decreased by 40.28% to 758,803,660.30 yuan from 1,270,636,709.44 yuan at the end of 2022[66] - The company's net profit attributable to shareholders for the year was -354,843,109.53 RMB, with a significant loss in the fourth quarter[59] - The company's recent three fiscal years have shown negative net profits after deducting non-recurring gains and losses, raising concerns about its ongoing operational capabilities[57] - The company's non-current asset disposal losses in 2023 amounted to -2,322,023.63 thousand yuan, compared to a gain of 2,913,871.36 thousand yuan in 2022 and 34,994,359.55 thousand yuan in 2021[90] - The company reported a net profit attributable to the parent company of -51,387.61 thousand yuan in 2023, accounting for 40.44% of the net assets at the end of the previous year[107] Product Development and R&D - The company is collaborating with the Chinese Academy of Sciences to develop a COVID-19 peptide nasal spray drug (HY3000)[31] - A partnership with the Chinese CDC aims to develop a peptide vaccine (HY3001) based on two patented technologies[31] - The company is working with Shenzhen Third People's Hospital to develop a COVID-19 antigen detection kit (HY3002)[31] - The company is involved in the development of new drugs, including Cabergoline and Atosiban, which are in various stages of clinical trials[49] - The company received approval for clinical trials of Semaglutide Injection from the National Medical Products Administration on December 4, 2023[69] - The company's Semaglutide Injection received clinical approval for diabetes treatment in December 2023[169] - The company's Vildagliptin Tablets, Octreotide Acetate Injection, and Terlipressin Injection were approved for market release in January 2023, with Terlipressin Injection indicated for esophageal variceal bleeding[161][162][163] - The company's injection of Cetrorelix Acetate was approved and passed consistency evaluation in July 2023[167] - Linaclotide capsule received clinical approval in May 2023[190] - Carbetocin injection was approved for new vaginal secretion indication in July 2023[192] - HY3000 nasal spray received clinical approval for treating mild to moderate COVID-19 in September 2023[193] - COVID-19 antigen test kit (latex method) was approved in September 2023[194] - Desmopressin acetate injection passed consistency evaluation in October 2023[195] - The company's HY3000 nasal spray, a novel peptide fusion inhibitor, demonstrated significant anti-COVID-19 effects in preclinical studies, showing strong inhibitory activity against multiple variants including Delta, Omicron BA.1, BA.2, and BA.4[167] - The company's R&D innovation focuses on weight loss, diabetes, and women's reproductive health products, as well as API export business[138] - The company's future development plans, product advantages, and R&D strengths were discussed with 25 investors[141] - The company's R&D investment, API business progress, and innovation drug development were discussed with institutional investors[141] - The company's international strategy and "weight loss drug" product layout were discussed with over 90 institutional investors[141] - The company's overseas business layout, current development status, and future plans were discussed with over 100 offline and 170,000 online investors[141] International Business and Strategy - International business contracts, mainly scheduled for 2024, contributed minimally to 2023 profits[7] - The company's overseas sales continued to grow in 2023, with the successful export of Liraglutide preparations and GLP-1 APIs, marking the initial success of its "Global Vision, Local Roots" international strategy[158] - The company's international strategy and "weight loss drug" product layout were discussed with over 90 institutional investors[141] - The company's overseas business layout, current development status, and future plans were discussed with over 100 offline and 170,000 online investors[141] Corporate Structure and Operations - The company's subsidiaries include Hong Kong HanYu, Wuhan HanYu, and Chengji Pharmaceutical, among others[27] - The company's operations span multiple locations, including Longhua headquarters, Pingshan branch, and Nanshan branch[27] - The company's stock code is 300199, and it is listed on the Shenzhen Stock Exchange[52] - The company's registered and office address is located in the Longhua District, Shenzhen, China[52] - The company's annual report is disclosed on major financial media platforms such as the Securities Times and the China Securities Journal[54] - The company's website is http://www.hybio.com.cn, and its email is hy@hybio.com.cn[52] - The company's legal representative is Zeng Shaogui[52] - The company's controlling shareholder and actual controller did not change during the reporting period[79][81] - The company's production model is based on "sales-driven production + small inventory" to ensure timely delivery[150] - The company's sales model includes direct sales and intermediary trade for APIs, and distribution and licensing for formulations[151] - The company has a leading position in peptide drug production and development, with a complete and efficient industrialization system[154] - The company has advanced R&D facilities, including over 300 specialized equipment from the US, Germany, and Switzerland[155] - The company has established a comprehensive quality management system, achieving 100% training qualification for employees and 100% compliance with registered process requirements[157] - The company has passed multiple certifications including China GMP, US FDA, Brazil, and EU certifications, and has undergone numerous audits and inspections by domestic and international regulatory bodies[157] - The company was listed among the top 500 manufacturing enterprises in Guangdong in 2023 and recognized as a "Specialized and Sophisticated" enterprise in Shenzhen[157] - The company's Wuhan subsidiary was awarded the title of "Outstanding Advanced Manufacturing Enterprise" in Huangpi District[157] Shareholder and Stock Information - The company canceled 33,685,704 shares in 2023, reducing the total number of shares from 699,719,517 to 666,033,813[72] - The proportion of restricted shares increased from 23.69% to 24.59% in 2023[71] - The top three shareholders, Zeng Shaogui, Zeng Shaoqiang, and Zeng Shaobin, held a total of 217,207,523 restricted shares at the end of 2023[74] - The company plans not to distribute cash dividends, issue bonus shares, or convert capital reserve into share capital[40] Government Subsidies and Non-Recurring Items - Government subsidies recognized in 2023 were 49,872,754.40 thousand yuan, a significant increase from 25,754,136.38 thousand yuan in 2022 and 46,683,413.96 thousand yuan in 2021[90] - The company's total non-recurring gains and losses in 2023 were 77,037,520.69 thousand yuan, compared to -56,025,540.62 thousand yuan in 2022 and 430,777,698.31 thousand yuan in 2021[91] - The company's financial assets and liabilities generated a fair value change and disposal gain of 31,511,232.36 thousand yuan in 2023, compared to losses of -82,559,111.99 thousand yuan in 2022 and -19,006,481.51 thousand yuan in 2021[91] - The company's other non-operating income and expenses in 2023 were -1,788,927.17 thousand yuan, compared to -1,517,471.56 thousand yuan in 2022 and -5,220,011.58 thousand yuan in 2021[91] - The company's long-term equity investment conversion to financial instruments generated an investment income of 376,846,594.64 thousand yuan in 2021[91] - The company's income tax impact in 2022 was 589,461.21 thousand yuan, compared to 3,252,501.84 thousand yuan in 2021[91] - The minority shareholders' equity impact in 2022 was 27,503.60 thousand yuan, compared to 267,674.91 thousand yuan in 2021[91] Intellectual Property and Patents - The company has nearly 400 domestic patents and dozens of international patents, and was recognized as an intellectual property advantage enterprise in 2022[133] - The company obtained 20 domestic patents in 2023, including patents for GLP-1 analog salt conversion and purification methods, as well as a solid-phase synthesis method for disulfide-bonded peptide drugs[170][172][173] - The parent company holds 277 domestic patents, including 271 invention patents, as of December 31, 2023[196] - A fully automatic injection pen was patented by Gansu Chengji Bio-Pharmaceutical Co., Ltd. in December 2016[200] Product Portfolio and Market Position - The company has 28 peptide drugs, 9 new drug certificates, and 31 clinical approvals, with a leading domestic market share for products like Terlipressin for Injection and Somatostatin for Injection[135] - The company's peptide API business is expected to grow steadily as global API market recovers and peptide drug patents expire, with 16 US DMFs, 5 EU DMFs, 5 EU CEPs, and 14 China DMFs[127] - Hanbei® Atosiban Acetate Injection received EU market approval in 2020 and passed the generic drug consistency evaluation in 2022[126] - The company has 16 products that have passed the generic drug consistency evaluation, including 11 peptide injections and 5 small molecule solid preparations[135] - The company's Desmopressin Acetate Injection is listed in the essential drug catalog and has advantages in market promotion[122] - The company's Carbetocin Injection has higher bioavailability and longer-lasting effects compared to traditional oxytocin, reducing the need for additional therapeutic uterotonics[124] - The company's Oxytocin Injection is a fourth-generation product with higher purity and fewer adverse reactions, meeting the 2015 Pharmacopoeia standards[123] - The company has established a high technical barrier in peptide API synthesis with over 20 years of experience, and strong customer loyalty, especially for products like Liraglutide[127] - The company implements strict quality control measures and risk management systems to ensure product quality and safety, including regular internal inspections and risk assessments[137] - Vildagliptin tablets are approved for monotherapy when diet and exercise fail to control blood sugar, and for combination therapy with metformin, insulin, or sulfonylureas when these treatments alone are insufficient[188] - Octreotide acetate injection is approved for controlling symptoms in acromegaly patients and treating bleeding from esophageal varices in cirrhosis patients[188] - Oxytocin injection passed consistency evaluation in March 2023[189]

根据《中华人民共和国公司法》、《中华人民共和国证券法》、《深圳证券交易所 创业板股票上市规则》、《深圳证券交易所上市公司自律监管指引第 2 号——创业板 上市公司规范运作》、《公司章程》以及《独立董事制度》等相关法律法规、规章制 度的有关规定，我们作为公司的独立董事，基于独立判断的立场，本着实事求是的 原则，召开了第五届董事会第二次独立董事专门会议，对下列事项进行了认真核查 和了解，并对公司相关事项发表了如下审核意见： 一、关于公司《2023年度利润分配预案》的审核意见 经审核，公司《2023 年度利润分配预案》符合《公司法》、《关于进一步落实 上市公司现金分红有关事项的通知》、《上市公司监管指引第 3 号——上市公司现 金分红》及《公司章程》等相关规定，有利于公司的持续稳定健康发展，不存在损 害股东尤其是中小股东利益的情况。我们同意本次董事会提出的关于公司《2022 年 度利润分配预案》，并同意将该议案提交股东大会审议。 深圳翰宇药业股份有限公司 第五届董事会第二次独立董事专门会议审核意见 三、关于作废2022年限制性股票激励计划部分已授予但尚未归属的限制性股票 的审核意见 经审核，公司本次作废部分已授予但 ...

深圳翰宇药业股份有限公司 内部控制自我评价报告 深圳翰宇药业股份有限公司全体股东： 根据《企业内部控制基本规范》及其配套指引的规定和其他内部控制监管要求（以下简称企 业内部控制规范体系），结合本公司（以下简称公司）内部控制制度和评价办法，在内部控制日常 监督和专项监督的基础上，我们对公司 2023 年 12 月 31 日的内部控制有效性进行了评价。 一、重要声明 按照企业内部控制规范体系的规定，建立健全和有效实施内部控制，评价其有效性，并如实 披露内部控制评价报告是公司董事会的责任。监事会对董事会建立和实施内部控制进行监督。经 理层负责组织领导企业内部控制的日常运行。公司董事会、监事会及董事、监事、高级管理人员 保证本报告内容不存在任何虚假记载、误导性陈述或重大遗漏，并对报告内容的真实性、准确性 和完整性承担个别及连带法律责任。 公司内部控制的目标是合理保证经营管理合法合规、资产安全、财务报告及相关信息真实完 整，提高经营效率和效果，促进实现发展战略。由于内部控制存在的固有局限性，故仅能为实现 上述目标提供合理保证。此外，由于情况的变化可能导致内部控制变得不恰当，或对控制政策和 程序遵循的程度降低，根据内部控 ...

深圳翰宇药业股份有限公司 经核查独立董事钟廉、胡文言、康志红的任职经历以及签署的相关自查文件， 2023年度上述人员未在公司担任除独立董事以外的任何职务，也未在公司主要股东 担任任何职务，与公司以及主要股东之间不存在利害关系或其他可能妨碍其进行独 立客观判断的关系，不存在其他影响独立董事独立性的情况。公司董事会认为公司 独立董事符合《上市公司独立董事管理办法》《深圳证券交易所上市公司自律监管 指引第2号——创业板上市公司规范运作》中关于独立董事的任职资格及独立性的要 求。 深圳翰宇药业股份有限公司董事会 2024年4月27日 董事会关于独立董事独立性情况的专项意见 根据《上市公司独立董事管理办法》《深圳证券交易所上市公司自律监管指引 第2号——创业板上市公司规范运作》等要求，深圳翰宇药业股份有限公司（以下简 称"公司"或"翰宇药业"）董事会就公司在任独立董事钟廉、胡文言、康志红的 独立性情况进行评估并出具如下专项意见： ...

证券代码：300199 证券简称：翰宇药业 公告编号：2024-030 深圳翰宇药业股份有限公司 关于举行2023年度暨2024年第一季度 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。 深圳翰宇药业股份有限公司（以下简称"公司"或"翰宇药业"）《2023年年 度报告全文》《2023年年度报告摘要》及《2024年第一季度报告》于2024年4月27日 在中国证监会指定创业板信息披露网站巨潮资讯网（http://www.cninfo.com.cn）披 露。为便于广大投资者更深入全面的了解公司情况，公司定于2024年5月10日（周 五）下午15:00-17:00举行2023年度暨2024年第一季度网上业绩说明会。本次说明会 将采用网络互动方式召开，投资者可登陆"价值在线"（www.ir-online.cn）参与本 次说明会。 一、召开时间、地点、方式 会议召开时间：2024年5月10日 15:00-17:00 会议地点：价值在线（www.ir-online.cn） 会议方式：网络互动方式 二、投资者参与方式 投资者可于2024年5月10日15: ...

深圳翰宇药业股份有限公司 2023 年度董事会工作报告 2023 年度，公司董事会按照《中华人民共和国公司法》（以下简称"《公司法》"）、 《中华人民共和国证券法》（以下简称"《证券法》"）、《深圳证券交易所创业板 股票上市规则》、《深圳证券交易所上市公司自律监管指引第 2 号——创业板上市 公司规范运作》、《公司章程》及《公司董事会议事规则》等法律、法规的要求， 本着对公司全体股东负责的原则，认真履行有关法律、法规赋予的职权，积极有效 地开展工作。现将董事会 2023 年主要工作情况报告如下： 一、报告期公司经营情况 2023 年对全球医药产业来说，是充满了机遇和挑战的一年，随着人们对健康和 生活质量的关注度不断提高，医药成为一个快速发展的产业。医药工业整体正朝着 高质量发展、研发创新、国际化、高端制造等方向迈进。回顾过去一年，翰宇药业 国际业务同比增长 41.58%，报告期内，公司完成坪山分公司、翰宇武汉、龙华总部 三地 FDA 现场检查工作，为未来产品投入市场打下夯实基础；从 2023 年第三季度 开始公司陆续签署了多个多肽制剂和原料药出口商业批订单，并已顺利进入履约发 货期。2023 年，国内重点多肽 ...

国浩律师（深圳）事务所 关于 深圳翰宇药业股份有限公司 二〇二二年限制性股票激励计划 作废部分限制性股票相关事项 的 法律意见书 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：518 ...

深圳翰宇药业股份有限公司 关联交易管理制度 第一章 总则 第一条 为规范深圳翰宇药业股份有限公司（以下简称"公司"或"本公司"）关联交易的决 策管理和信息披露等事项，确保公司的关联交易行为不损害公司和全体股东特别是无关联 关系股东的利益，根据《中华人民共和国公司法》《中华人民共和国证券法》《企业会计 准则》《深圳证券交易所创业板股票上市规则》及其他有关法律法规、规范性文件和《公 司章程》的规定，结合公司实际情况，特制定本制度。 第二条 公司关联交易的决策管理、信息披露等事项，应当遵守本制度。 第三条 公司处理关联交易事项，应当遵循下列原则： （一）诚实信用的原则； （二）公开、公平、公正的原则； （三）依据客观标准判断的原则； （四）实质重于形式的原则。 第二章 关联人和关联关系 第四条 公司关联人包括关联法人和关联自然人。 第五条 具有下列情形之一的法人或其他组织，为本公司的关联法人： （一）直接或间接地控制公司的法人或其他组织； （二）由前项所述法人直接或间接控制的除本公司及其控股子公司以外的法人或其他 组织； （三）由第六条所列本公司的关联自然人直接或间接控制的，或担任董事（独立董事 除外）、高级管理人 ...