2023 年半年度定期现场检查报告 | 保荐机构名称：安信证券股份有限公司 被保荐公司简称：海特生物 | | | | | --- | --- | --- | --- | | 保荐代表人姓名：孙素淑 联系电话：021-55518389 | | | | | 保荐代表人姓名：燕云 联系电话：021-35082978 | | | | | 现场检查人员姓名：孙素淑、卢增桐 | | | | | □下半年 现场检查对应期间：√上半年 | | | | | 现场检查时间：2023 年 月 日-2023 年 月 日 7 19 7 19 | | | | | 一、现场检查事项 | | | 现场检查意见 | | （一）公司治理 | 不 适 | 是 | 否 | | | 用 | | | | 现场检查手段： | | | | | 1、查看公司的公开信息披露文件； 2、查阅公司三会文件，包括会议通知、议案、会议记录、决议等； | | | | | 3、查看公司主要经营、管理场所 | | | | | 1.公司章程和公司治理制度是否完备、合规 | | √ | | | 2.公司章程和三会规则是否得到有效执行 | | √ | | | 3.三会会议记录是否 ...

武汉海特生物制药股份有限公司（以下简称"公司"）于近日取得湖北省药 品监督管理局换发的《药品生产许可证》，同意《药品生产许可证》的变更申请。 变更后新增了生产范围，其他内容不变。变更后的《药品生产许可证》具体内容 如下： 一、 《药品生产许可证》基本情况 证券代码：300683 证券简称：海特生物 公告编号：2023-056 武汉海特生物制药股份有限公司 关于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。 许可证编号：鄂 20200224 企业名称：武汉海特生物制药股份有限公司 注册地址：武汉经济技术开发区海特科技园 社会信用代码：91420100724667038L 法定代表人：陈亚 企业负责人：陈亚 质量负责人：赵满岐 分类码：AshBhCh 生产地址和生产范围： 1.湖北省武汉经济技术开发区海特科技园：治疗用生物制品（注射用抗乙型 肝炎转移因子，注射用鼠神经生长因子，注射用重组变构人肿瘤坏死因子相关凋 亡诱导配体）、冻干粉针剂、散剂、小容量注射剂、片剂、颗粒剂、硬胶囊剂、 口服混悬剂。*** 2.受托方：湖北四环制药有限公司 ...

Financial Performance - The company's operating revenue for the first half of 2023 was ¥286,449,829.65, a decrease of 26.03% compared to ¥387,232,225.48 in the same period last year[23]. - The net profit attributable to shareholders was -¥11,127,732.26, representing a decline of 158.96% from a profit of ¥18,872,041.54 in the previous year[23]. - The net cash flow from operating activities was -¥31,156,096.22, a decrease of 9.44% compared to -¥28,468,023.50 in the same period last year[23]. - The total assets at the end of the reporting period were ¥2,939,886,036.37, an increase of 8.63% from ¥2,706,360,990.39 at the end of the previous year[23]. - The company's weighted average return on equity was -0.48%, down from 0.80% in the previous year, indicating a significant decline in profitability[23]. - The company's revenue for the reporting period was ¥286,449,829.65, a decrease of 26.03% compared to ¥387,232,225.48 in the previous year[82]. - The company's R&D investment decreased by 14.08% to ¥51,981,891.33 from ¥60,503,393.53 year-on-year[82]. - The company's sales expenses increased by 14.04% to ¥67,526,165.36 from ¥59,212,692.61 year-on-year[82]. Market and Industry Outlook - The global biopharmaceutical market is projected to grow from $338.4 billion in 2021 to $814.8 billion by 2030, with a compound annual growth rate (CAGR) of approximately 10.3%[34]. - The Chinese biopharmaceutical market is expected to expand from ¥410 billion in 2021 to ¥1,199.1 billion by 2030, with a CAGR of about 12.7%[35]. - The global CRO market size increased from $49 billion in 2017 to $71 billion in 2021, with a CAGR of 9.7%, and is expected to reach $118.5 billion by 2026, growing at a CAGR of 10.8% from 2021 to 2026[39]. - The Chinese CRO market size grew from RMB 29 billion in 2017 to RMB 63.9 billion in 2021, achieving a CAGR of 21.8%, and is projected to reach RMB 187.8 billion by 2026, with a CAGR of 24.1% from 2021 to 2026[40]. Research and Development - The company has a focus on developing new drugs, particularly in the oncology sector, with ongoing research and development efforts[3]. - The company is involved in contract research and manufacturing organizations (CRO and CDMO) to enhance its drug development capabilities[15]. - The company has established over 10 advanced formulation and raw material development platforms, capable of supporting more than 200 projects simultaneously[41]. - The company has developed capabilities for over 30 dosage forms, including platforms for oral sustained release and innovative drug research[50]. - The company is focusing on optimizing talent structure, building R&D platforms, and broadening R&D fields to strengthen its independent R&D system[70]. - The company is developing multiple small molecule chemical generic drugs and active pharmaceutical ingredients, with progress reported as smooth[70]. - The company has established an independent technology center with a strong R&D team specializing in biotechnology, pharmaceutical engineering, and drug formulation, enhancing its new product development capabilities[56]. Compliance and Risk Management - The company faces various risks including industry policy risks, new drug registration and market risks, and management risks due to scale expansion[3]. - The company has a commitment to maintaining compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) standards[15]. - The company emphasizes strict management of raised funds to mitigate risks associated with increased fixed and intangible assets, which could adversely affect operating performance if expected returns are not achieved[123]. - The company is committed to adjusting its operational strategies in response to changes in national pharmaceutical regulations to enhance its market competitiveness[116]. Environmental Management - The company has a wastewater treatment capacity of 500 tons per day, utilizing an "anaerobic + SBR + flotation + disinfection" process, ensuring all wastewater meets discharge standards[138]. - The company has implemented a comprehensive pollution control strategy, including regular monitoring and maintenance of environmental facilities[138]. - The company invested approximately 1.787 million yuan in environmental governance and protection during the reporting period[140]. - The company has established an emergency response plan for environmental incidents, which has been filed with the environmental protection department[140]. Corporate Governance and Shareholder Information - The company has established a comprehensive corporate governance structure in compliance with relevant laws and regulations[142]. - The company has set up a workers' representative assembly and a trade union to protect employees' rights[144]. - The company reported a total of 9,639 shareholders at the end of the reporting period[183]. - The largest shareholder, Wuhan Sanjiangyuan Investment Development Co., Ltd., holds 30.56% of the shares, totaling 40,000,000 shares[184]. - The company is committed to maintaining transparency with its investors regarding shareholding changes and corporate strategies[183]. Subsidiaries and Acquisitions - The company acquired 100% equity of Hankan Pharmaceutical, enhancing its R&D capabilities and reducing reliance on single products[106]. - The company has established a new subsidiary, Tianjin Hankan Innovation Pharmaceutical Research Co., Ltd., which is included in the consolidated financial statements[115]. - The company’s subsidiary, Xiamen Weijia, specializes in the industrialization of antiviral drugs and is a supplier of APIs and intermediates for antiviral medications[48]. Financial Transactions and Fund Management - The company has established a dedicated bank account for the management of raised funds, with the accounting department maintaining detailed records of fund usage and project investments[100]. - The company has no overdue or unrecoverable amounts in its entrusted financial management, indicating strong financial health[108]. - The company has provided loans totaling 9,750 million yuan to Beijing Shadong Biotechnology Co., Ltd. at an interest rate of 3.65% for new drug R&D projects[110].

证券代码：300683 证券简称：海特生物 公告编号：2023-047 武汉海特生物制药股份有限公司 2023年第一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。 特别提示： 1、本次股东大会召开期间没有增加、否决或变更议案情况发生； 2、本次股东大会没有涉及变更前次股东大会决议； 3、本次股东大会采取现场投票和网络投票相结合的方式召开。 一、会议召开和出席情况 （四）会议召开方式：本次大会采取现场投票和网络投票相结合的方式。 （五）会议主持人：公司董事长陈亚先生。 （六）会议召开的合法、合规性：本次股东大会的召开符合有关法律、行政 法规、部门规章、规范性文件和《公司章程》等相关规定。 （七）会议出席情况 1、股东出席的总体情况 （一）会议召开时间 （1）现场会议召开时间：2023 年 8 月 22 日（星期二）14:30。 （2）网络投票时间：2023 年 8 月 22 日。 其中：通过深圳证券交易所交易系统进行网络投票的具体时间为：2023 年 8 月 22 日的交易时间，即 9:15-9:25，9:30-11:30 和 13:00 ...

北京中伦（武汉）律师事务所 关于武汉海特生物制药股份有限公司 2023 年第一次临时股东大会的 法律意见书 二〇二三年八月 北京 • 上海 • 深圳 • 广州 • 武汉 • 成都 • 重庆 • 青岛 • 杭州 • 南京 • 海口 • 东京 • 香港 • 伦敦 • 纽约 • 洛杉矶 • 旧金山 • 阿拉木图 Beijing • Shanghai • Shenzhen • Guangzhou • Wuhan • Chengdu • Chongqing • Qingdao • Hangzhou • Nanjing • Haikou • Tokyo • Hong Kong • London • New York • Los Angeles • San Francisco • Almaty 武汉市江汉区建设大道 568 号新世界国贸大厦 I 座 50 层 邮政编码：430022 50/F, New World International Trade Tower, 568 Jianshe Road, Jianghan District, Wuhan 430022, P.R.China 电话/Tel：(8627) 8555 ...

安信证券股份有限公司 关于武汉海特生物制药股份有限公司 以简易程序向特定对象发行股票限售股份上市流通的核查意见 安信证券股份有限公司（以下简称"安信证券"、"保荐机构"）作为武汉海 特生物制药股份有限公司（以下简称"海特生物"、"公司"、"上市公司"、"发行 人"）以简易程序向特定对象发行股票的保荐机构，根据《证券发行上市保荐业 务管理办法》《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》《深圳证券交易所创业板股票上市规则（2023 年修订）》等法律法 规和规范性文件规定，对海特生物以简易程序向特定对象发行股票限售股份持有 人持有的限售股份将上市流通情况进行了认真、审慎的核查，相关核查情况及核 查意见如下： 一、 本次上市流通的限售股类型 公司于 2023 年 1 月 20 日收到中国证券监督管理委员会（以下简称"中国证 监会"）出具的关于同意武汉海特生物制药股份有限公司向特定对象发行股票注 册的批复》（证监许可[2023]14 号），同意公司向特定对象发行 A 股股票的注册 申请。 公司向 8 名特定对象发行人民币普通股（A 股）8,790,226 股，并已于 2023 年 2 ...

证券代码：300683 证券简称：海特生物 公告编号：2023-046 武汉海特生物制药股份有限公司 关于以简易程序向特定对象发行股票解除限售上市流通的提示性公告 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。 特别提示： 1. 本次解除限售的股份为公司以简易程序向特定对象发行的股份，本次解 除限售股份数量为 8,790,226 股，占总股本的 6.7155%。 2. 本次解除限售后可实际上市流通数量为 8,790,226 股，占总股本的 6.7155%。上市流通日为 2023 年 8 月 15 日。 3. 本次申请解除股份限售的股东 8 名，涉及的证券账户 47 个。 一、本次解除限售股份发行情况和公司股本变动情况 二、本次解除限售的股东承诺履行情况 1、本次解除限售的股东有：诺德基金管理有限公司、财通基金管理有限公 司、沈祥龙、UBS AG、深圳市前海久银投资基金管理有限公司-久银定增 10 号 私募证券投资基金、国都创业投资有限责任公司-国都犇富 5 号定增私募投资基 金、张建飞、上海铂绅投资中心（有限合伙）-铂绅二十九号证券投资私募基金。 上述股东在公 ...

证券代码： 300683 证券简称：海特生物 武汉海特生物制药股份有限公司投资者关系活动记录表 编号：2023-002 | 投资者 | □特定对象调研 分析师会议 | | --- | --- | | 关系活 动类别 | □媒体采访 业绩说明会 | | | □新闻发布会 □路演活动 | | | □现场参观 | | | 其他 投资者网上集体接待日活动  | | 参与单 位名称 | 通过全景网"投资者关系互动平台"（https://ir.p5w.net ）参与 2023 | | 及人员 | 年湖北辖区上市公司投资者网上集体接待日活动的投资者。 | | 姓名 | | | 时间 | 2023 年 5 月 25 日（星期四）14：30-16：35 | | 地点 | 全景网"投资者关系互动平台"（https://ir.p5w.net） | | 上市公 | | | 司接待 | 副总经理兼董事会秘书陈煌先生、财务总监夏汉珍女士 | | 人员姓 | | | 名 | | 2023 年 5 月 25 日下午 14：30-16：35，公司以网络在线交流方式参 加湖北证监局、湖北省上市公司协会、深圳市全景网络有限公司联合 举办的" ...

证券代码：300683 证券简称：海特生物 公告编号：2023-034 武汉海特生物制药股份有限公司 关于参加2023年湖北辖区上市公司投资者 网上集体接待日活动的公告 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。 重要内容提示： 1、召开时间：2023年5月25日（星期四）14:30-16:35 2、召开方式：网络在线交流方式 一、活动安排 为进一步加强武汉海特生物制药股份有限公司（以下简称"公司"）与投资 者互动交流，便于广大投资者更深入全面地了解公司情况，公司决定于2023年5 月25日14:30-16:35以网络在线交流方式参加湖北证监局、湖北省上市公司协会、 深圳市全景网络有限公司联合举办的"2023年湖北辖区上市公司投资者网上集体 接待日活动"。公司将积极参与活动，并围绕2022年度业绩、公司治理、经营状 况、可持续发展情况等投资者所关心的问题，通过互动平台与投资者进行沟通交 流。 二、活动的时间、方式 活动时间：2023 年 5 月 25 日（星期四）14：30-16：35 活动方式：网络远程形式，通过"全景路演"网站（http://rs.p5 ...

Financial Performance - The company's revenue for Q1 2023 was ¥138,635,351.99, a decrease of 16.59% compared to ¥166,204,766.30 in the same period last year[5] - The net profit attributable to shareholders was a loss of ¥1,472,018.93, representing a decline of 119.14% from a profit of ¥7,690,523.54 in the previous year[5] - Total operating revenue for Q1 2023 was ¥138,635,351.99, a decrease of 16.66% from ¥166,204,766.30 in the previous period[20] - Net profit for Q1 2023 was a loss of ¥1,715,296.26, compared to a profit of ¥10,090,383.29 in the same period last year[21] - The total comprehensive income for Q1 2023 was -1,715,296.26 CNY, down from 10,090,383.29 CNY in Q1 2022[22] - The basic and diluted earnings per share for Q1 2023 were both -0.02 CNY, compared to 0.06 CNY in the previous year[22] Cash Flow - The net cash flow from operating activities improved by 50.46%, amounting to -¥20,025,031.14 compared to -¥40,422,326.86 in the same period last year[5] - Cash inflows from operating activities totaled 159,114,665.15 CNY, a decrease from 167,526,359.10 CNY in the prior year[24] - The net cash flow from operating activities was -20,025,031.14 CNY, improving from -40,422,326.86 CNY in Q1 2022[24] - Cash inflows from investment activities were 282,677,828.84 CNY, compared to 115,509,501.15 CNY in the same period last year[24] - The net cash flow from investment activities was -349,381,558.66 CNY, worsening from -50,032,485.34 CNY in Q1 2022[24] - The net cash flow from financing activities was 286,697,791.17 CNY, compared to -3,650,000.00 CNY in the previous year[24] - The ending cash and cash equivalents balance was 665,809,620.43 CNY, up from 88,220,234.04 CNY in Q1 2022[25] - The company’s cash and cash equivalents decreased by 82,668,239.85 CNY during the quarter, an improvement from a decrease of 94,104,812.20 CNY in the same period last year[25] Assets and Liabilities - Total assets increased by 11.10% to ¥3,006,675,601.06 from ¥2,706,360,990.39 at the end of the previous year[5] - Total liabilities rose to ¥384,626,658.33 from ¥371,203,811.43, an increase of 3.43%[18] - The company's inventory increased to ¥144,527,340.20 from ¥120,180,940.03, a rise of 20.19%[18] - The company's total equity increased to ¥2,622,048,942.73 from ¥2,335,157,178.96, an increase of 12.34%[18] - The company's equity attributable to shareholders rose by 12.43% to ¥2,597,506,071.64 from ¥2,310,371,030.54 at the end of the previous year[5] Shareholder Information - The total number of common shareholders at the end of the reporting period is 10,107[12] - The largest shareholder, Wuhan Sanjiangyuan Investment Development Co., Ltd., holds 30.56% of shares, totaling 40,000,000 shares[12] - Chen Ya, an overseas individual shareholder, holds 8.44% of shares, totaling 11,050,000 shares, with 8,600,000 shares under lock-up[12] - The total number of restricted shares at the beginning of the period was 9,547,250, with 225,000 shares released and 8,790,226 shares added, resulting in a total of 18,112,476 restricted shares at the end of the period[14] - The company has a significant number of shareholders involved in financing and securities trading, with Jiang Shufen holding a total of 973,200 shares[12] - The company has a total of 1,489,868 shares under lock-up for Shen Xianglong, which will be released on August 15, 2023[14] - The total number of shares held by the top ten unrestricted shareholders is 40,000,000 shares[12] - The company has a diverse shareholder base, including both domestic and foreign investors[12] - The report indicates a focus on long-term strategies with locked shares for key executives and major shareholders[14] Investment and R&D - The company reported a significant increase of 250.07% in trading financial assets, reaching ¥504,255,857.15 due to increased investment in financial products[9] - Research and development expenses increased by 50.27% to ¥1,513,568.31, indicating a focus on innovation[9] - Research and development expenses for Q1 2023 were ¥24,195,180.16, down from ¥29,760,335.70, a decrease of 18.67%[21] - The company has plans for market expansion and product development, as indicated by the involvement of various investment funds[14] Operating Costs - Total operating costs for Q1 2023 were ¥154,418,438.44, down from ¥161,615,613.80, reflecting a reduction of 4.83%[21]