证券代码：300199 证券简称：翰宇药业 公告编号：2023-070 深圳翰宇药业股份有限公司 第五届监事会第十三次会议决议公告 本公司及监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。 一、监事会会议召开情况 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 8 月 1 日以电子邮件并电话通知方式向公司全体监事发出了召开第五届监事会第十三次 会议通知。 本次会议于 2023 年 8 月 11 日下午 16:30 在公司龙华总部 2006 董事会会议室以 现场方式召开。会议应到监事 3 名，实到监事 3 名。本次会议由监事会主席李庆洋 先生主持，部分高级管理人员列席了本次会议。 本次会议的召集、召开符合《中华人民共和国公司法》和《公司章程》的有关 规定，会议决议合法、有效。 1 证券发行注册管理办法》（以下简称《注册管理办法》）《<上市公司证券发行注册 管理办法>第九条、第十条、第十一条、第十三条、第四十条、第五十七条、第六十 条有关规定的适用意见——证券期货法律适用意见第18号》（以下简称《证券期货 法律适用意见第18号》）《上市规则》《深 ...

深圳翰宇药业股份有限公司 章程 二〇二三年八月 目 录 第四章 股东和股东大会 第五章 董事会 第六章 总裁及其他高级管理人员 第七章 监事会 第八章 财务会计制度、利润分配和审计 第九章 通知与公告 第十章 合并、分立、增资、减资、解散和清算 第一章 总则 第二章 经营宗旨和范围 第三章 股份 第十二章 附则 第一节 财务会计制度 第二节 内部审计 第三节 会计师事务所的聘任 第一节 通知 第二节 公告 第一节 合并、分立、增资和减资 第二节 解散和清算 第十一章 修改章程 第一章 总则 第一条 为维护深圳翰宇药业股份有限公司（以下简称"公司"）股东和债权人 的合法权益，规范公司的组织和行为，根据《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》）和其他有关规定，制订本 章程。 第二条 公司系依照《公司法》和其他有关规定成立的股份有限公司（以下简 称"公司"）。 经深圳市科技工贸和信息化委员会 2009 年 10 月 26 日下发之"深科工贸信资字 [2009]0437 号"《关于深圳市翰宇药业有限公司变更为股份有限公司的批复》批准， 公司由深圳市翰宇药业有限公司 ...

证券代码：300199 证券简称：翰宇药业 公告编号：2023-079 深圳翰宇药业股份有限公司 关于召开2023年第二次临时股东大会的通知 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8月11日召 开第五届董事会第十八次会议，审议通过了《关于提请召开2023年第二次临时股东 大会的议案》，现就2023年第二次临时股东大会相关事项通知如下： 一、会议基本情况 1、股东大会届次：2023年第二次临时股东大会 2、会议召集人：公司董事会 3、公司第五届董事会第十八次会议同意召开本次股东大会，本次会议召开符合 有关法律、行政法规、规范性文件和《公司章程》的规定。 4、会议召开方式：本次会议采取现场投票和网络投票相结合的方式。公司将通 过深圳证券交易所交易系统和互联网投票系统（http://wltp.cninfo.com.cn）向全体股 东提供网络形式的投票平台，公司股东可以在网络投票时间内通过上述系统行使表 决权。 5、会议召开时间： （1）现场会议召开时间：2023年8月30日（周三）下午15 ...

证券代码：300199 证券简称：翰宇药业 公告编号：2023-073 深圳翰宇药业股份有限公司 深圳翰宇药业股份有限公司董事会 关于公司向银行申请授信额度的公告 2023 年 8 月 15 日 以上向银行申请综合授信额度事项授权公司董事长就相关授信文件签字或盖章、 授权经营层根据资金需求情况在前述授信额度内使用。 特此公告！ 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"）于 2023 年 8 月 11 日召开了第五届董事会第十八次会议审议通过了《关于公司向银行申请授信额 度的议案》。同意公司向浙商银行股份有限公司深圳分行申请总额度不超过 2 亿元 人民币的综合授信，授信期限不超过 1 年。借款抵押物为公司部分机器设备、全资 子公司甘肃成纪生物药业有限公司名下 4 套房产物业、不少于 1.5 亿元应收账款质 押担保及实际控制人提供连带责任保证担保。 上述授信额度最终以银行实际审批的结果为准，具体使用额度将在银行批准的 额度范围内视公司运营资金的实际需求来确定。 ...

鉴于公司最近五个会计年度（2018-2022 年）不存在通过配股、增发、可转换 公司债券等方式募集资金的情况，公司前次募集资金到账时间距今已超过五个会计 年度。因此公司本次向特定对象发行股票无需编制前次募集资金使用情况报告，亦 无需聘请会计师事务所出具前次募集资金使用情况鉴证报告。 特此公告！ 深圳翰宇药业股份有限公司董事会 证券代码：300199 证券简称：翰宇药业 公告编号：2023-077 深圳翰宇药业股份有限公司 关于无需编制前次募集资金使用情况报告的公告 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。 根据《监管规则适用指引——发行类第 7 号》有关规定："前次募集资金使用 情况报告对前次募集资金到账时间距今未满五个会计年度的历次募集资金实际使用 情况进行说明，一般以年度末作为报告出具基准日，如截止最近一期末募集资金使 用发生实质性变化，发行人也可提供截止最近一期末经鉴证的前募报告。" 2023 年 8 月 15 日 ...

Group 1: R&D Investment and Strategy - The company has adopted a hybrid strategy of generic and innovative drugs, with R&D expenses accounting for 22.53% of revenue in 2022 [1] - The company emphasizes innovation in R&D, focusing on peptide drug development, with a rich product pipeline targeting diabetes, obesity, infections, osteoporosis, and rare diseases [1] Group 2: Raw Material Business Progress - The company has over 20 years of experience in peptide raw material synthesis, establishing a strong technical barrier and high customer loyalty [2] - The raw material business has seen a compound annual growth rate (CAGR) of 48.27% over the past three years, with overseas revenue growing by 68.86% in 2022 compared to 2021 [2] - The company has secured 16 US DMFs, 5 EU DMFs, and 5 EU CEPs, facilitating international business expansion [2] Group 3: Health Industry and Product Development - The company is exploring applications of peptides in health-related scenarios such as obesity, insomnia, and high uric acid levels [2] - The HY3000 project, aimed at developing a broad-spectrum nasal spray for COVID-19, is currently in Phase IIb clinical trials [2][3] - The company is also advancing other products, including nebulizers and nasal sprays, which are in the listing application stage [3] Group 4: Financing and Expansion Plans - The company has approved a simplified procedure for issuing shares and non-public bonds to raise funds primarily for core business projects and working capital [3] - Part of the raised funds may be allocated for expanding the raw material production capacity due to rapid growth in this sector [3]

证券代码：300199 证券简称：翰宇药业 深圳翰宇药业股份有限公司 投资者关系活动记录表 编号：2023 - 002 | | ☐特定对象调研 ☐分析师会议 | | --- | --- | | | ☐媒体采访 业绩说明会 | | 投资者关系活动类别 | ☐新闻发布会 ☐路演活动 | | | ☐现场参观 | | | ☐其他（请文字说明其他活动内容） | | 形式 | ☐电话会议 ☐现场 网上 | | 参与单位名称及人员姓名 | 通过价值在线（www.ir-online.cn）参与公司 2022 年度暨 2023 年 | | | 第一季度网上业绩说明会的投资者 | | 时间 | 2023 年 05 月 10 日 15:00-17:00 | | | 女士 | | | 董事长 曾少贵先生 董事、执行总裁 PINXIANG YU | | | 董事、副总裁 唐洋明先生 | | 上市公司接待人员姓名 | 董事、副总裁兼董事会秘书 杨笛女士 | | | 独立董事 李瑶女士 | | | 副总裁 曾兆辉先生 | | | 副总裁 张敏女士 | | | 副总裁兼财务总监 涂鸿鸿先生。 提问环节 | | | （1）公司2022年实 ...

Financial Performance - The company's operating revenue for Q1 2023 was ¥176,222,802.86, an increase of 5.39% compared to ¥167,212,356.18 in the same period last year[12]. - Net profit attributable to shareholders was ¥18,605,574.69, a significant turnaround from a loss of ¥57,654,813.97 in Q1 2022, representing a 132.27% increase[12]. - Total operating revenue for Q1 2023 was CNY 176,222,802.86, an increase from CNY 167,212,356.18 in Q1 2022, representing a growth of approximately 6.02%[36]. - Total comprehensive income amounted to 17,034,797.38, a significant decrease from -58,783,748.60 in the previous period[50]. - Basic and diluted earnings per share were both 0.02, compared to -0.06 in the prior period[50]. - Total profit amounted to 16,922,305.70, a recovery from a total loss of 58,298,888.42 in the previous year, showcasing a strong financial rebound[58]. Cash Flow - The net cash flow from operating activities was -¥37,499,158.99, a decline of 281.02% compared to a positive cash flow of ¥20,715,953.56 in the previous year[12]. - Cash inflows from operating activities totaled 196,699,999.31, slightly down from 200,624,150.18 in the previous period[51]. - Cash inflows from financing activities totaled 50,770,057.91, compared to 23,073,485.61 in the previous period[53]. - Net cash flow from financing activities was 2,107,882.75, a recovery from -19,092,072.43 in the prior period[53]. - The ending cash and cash equivalents balance was 75,620,737.93, down from 108,536,391.98 in the previous period[53]. Assets and Liabilities - Total assets at the end of Q1 2023 were ¥3,581,678,275.24, a slight decrease of 0.82% from ¥3,611,233,247.62 at the end of 2022[12]. - The company's total liabilities increased by 37.64% for current non-current liabilities due within one year, rising to ¥631,767,405.56 from ¥458,991,408.69[15]. - Non-current liabilities totaled 973,331,387.59 RMB, a decrease from 1,166,334,845.97 RMB[48]. - Total liabilities amounted to 2,255,517,801.30 RMB, compared to 2,314,291,599.94 RMB previously[48]. - The company's total equity attributable to shareholders was 1,300,195,773.92 RMB, an increase from 1,270,636,709.44 RMB[48]. Research and Development - Research and development expenses increased by 104.10% to ¥44,393,211.43, up from ¥21,750,925.60 in Q1 2022, primarily due to increased clinical trial costs[17]. - The company is focusing on expanding its market presence and developing new products, although specific details were not disclosed in the report[34]. - Future outlook includes continued investment in research and development to enhance product offerings and market competitiveness[34]. - Research and development expenses increased to 44,393,211.43, up from 21,750,925.60, reflecting the company's commitment to innovation and new product development[58]. Shareholder Information - Total number of common shareholders at the end of the reporting period was 62,213[42]. - The largest shareholder, Zeng Shaogui, holds 15.18% of shares, totaling 134,106,167 shares[42]. - The company completed the cancellation of 33,685,704 shares, reducing the total share capital from 916,927,040 shares to 883,241,336 shares[30]. Other Financial Metrics - The fair value change income from trading financial assets was ¥27,781,417.40, a significant recovery from a loss of -¥73,474,633.62 in the same quarter last year, marking a 137.81% improvement[17]. - The company reported a decrease in credit impairment losses to -1,766,646.00, compared to an increase of 3,035,076.61 in the prior period, indicating improved asset quality[58]. - The company experienced a significant increase in other income, which rose to 19,243,596.09 from 5,800,804.37, contributing positively to overall profitability[58]. - Financial expenses rose to 28,792,735.05, compared to 21,251,449.59, primarily driven by interest expenses of 27,907,368.98, which increased from 20,880,968.42[58].

Product Development and Pipeline - The company has developed a total of 24 peptide drugs, with 9 new drug certificates and 26 clinical approvals, establishing a strong product pipeline in key therapeutic areas such as reproductive health, digestive hemostasis, metabolism, and anti-infection [4]. - The company has a robust pipeline with short-term plans for liraglutide injection and teriparatide injection, and mid-term plans for semaglutide and abaparetide, indicating a strategic focus on high-impact products [16]. - The company is actively expanding its product portfolio with new product approvals and ongoing clinical trials, positioning itself for future growth [40]. - The company has received marketing approval for multiple products, including HY3001 peptide vaccine and various injection solutions, enhancing its core competitiveness [40]. - The company has received approval for the Vildagliptin tablets as a Class 4 chemical drug in January 2023, which is considered equivalent to passing the consistency evaluation [82]. - The company has developed a new nasal spray drug for COVID-19, in collaboration with the Institute of Microbiology, Chinese Academy of Sciences [117]. - The company is also working on a new antigen detection kit for COVID-19 in partnership with Shenzhen National Infectious Disease Clinical Medical Research Center [117]. - The company has received approvals for several diabetes-related products, including the Sitagliptin Metformin tablets and Vildagliptin tablets [198]. Market Position and Sales Performance - The company has achieved a leading position in the domestic market for peptide drugs, with significant market shares for products like injection terlipressin and somatostatin [4]. - The company’s domestic sales accounted for approximately ¥625.06 million, a decrease of 9.28% compared to the previous year [26]. - The sales volume of the company's formulations decreased by 5.33% year-on-year, totaling approximately ¥575.26 million [25]. - The company reported a significant increase in contract liabilities, which rose by 0.56% to 1.74% of total liabilities [61]. - The company reported a net profit attributable to shareholders of -¥370,550,318.41 for 2022, representing a significant decline of 1,302.78% from a profit of ¥30,807,791.13 in 2021 [125]. - The company has a market share of approximately 75% for its injection of terlipressin in the domestic market [140]. Research and Development - In 2022, the company passed consistency evaluations for 12 generic products, including 7 peptide injections and 5 small molecule solid preparations, demonstrating its focus on peptide research and development [4]. - The research and development expenses increased by 50.15% to approximately ¥158.68 million, primarily due to increased clinical trial costs and outsourced development fees [39]. - The company has filed several patents, including methods for peptide desalting and synthesis of desmopressin, indicating ongoing innovation efforts [21]. - The company’s R&D center has been recognized as a provincial and national engineering technology research center, emphasizing its commitment to innovation in peptide drugs [182]. - The company has established joint research centers with leading institutions to enhance its R&D capabilities in peptide drugs and synthetic biology [81]. - The company is focusing on the development of high-end generics and innovative drugs, with significant investments planned for new product development [172]. Financial Performance - The company's pharmaceutical manufacturing revenue for 2022 was approximately ¥704.32 million, a decrease of 4.30% compared to 2021 [25]. - The company reported a gross margin of 77.34% for its pharmaceutical manufacturing segment, an increase of 5.29% year-on-year [25]. - Cash flow from operating activities decreased by 89.92% to ¥15,807,431.54 compared to the previous year [64]. - The total assets at the end of 2022 were ¥3,611,233,247.62, a decrease of 7.56% from ¥3,906,390,317.84 at the end of 2021 [125]. - The company reported a basic earnings per share of -¥0.42 for 2022, a decline of 1,500.00% compared to ¥0.03 in 2021 [125]. - The company reported a net profit of 300 million RMB for 2022, with a net profit margin of 25% [113]. Regulatory Compliance and Quality Assurance - The company received EU CEP certification for octreotide raw materials and FDA approval for acetic acid ganirelix raw materials in November 2022, indicating successful international registration efforts [10]. - The company emphasizes its commitment to quality management, having achieved certifications from multiple international standards including FDA and EU GMP, ensuring high-quality production processes [160]. - The company has successfully passed multiple audits and inspections from domestic and international regulatory bodies, reinforcing its reputation for quality assurance [161]. - The company is committed to maintaining compliance with medical device regulations, ensuring all products are registered and valid for clinical use [56]. Strategic Partnerships and Collaborations - The company has established strategic partnerships with several authoritative research institutions, enhancing its research capabilities and resource integration [16]. - The company has established a strong management advantage through collaboration with renowned experts and institutions [81]. - The company is exploring potential mergers and acquisitions to accelerate growth and enhance its competitive position in the pharmaceutical industry [113]. Challenges and Future Outlook - The company has faced significant risks and challenges, which are detailed in the management discussion and analysis section of the report [95]. - The company emphasizes that forward-looking statements regarding development strategies and future plans do not constitute substantive commitments to investors [95]. - The company plans to continue optimizing and upgrading its product structure to maintain its competitive position in the peptide drug sector [136]. - The company aims to enhance its product pipeline with the approval of new products and consistent evaluation of existing drugs [139]. - The company is actively pursuing new product development and market expansion strategies to enhance its competitive position [56].

证券代码：300199 证券简称：翰宇药业 公告编号：2023-045 深圳翰宇药业股份有限公司 关于举行2022年度暨2023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"）《2022年年度报告 全文》《2022年年度报告摘要》及《2023年第一季度报告》于2023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2023年5月10日（周三）下午 15:00-17:00举行2022年度网上业绩说明会。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：2023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2023年5月10日15:00-17:00通过网 ...