一、 关于公司《2023 年半年度募集资金存放与实际使用情况的专项报告》 的独立意见 经审议，全体独立董事认为：公司 2023 年半年度募集资金的存放与实际使 用情况符合《上市公司监管指引第 2 号——上市公司募集资金管理和使用的监管 要求（2022 年修订）》《上海证券交易所科创板上市公司自律监管指引第 1 号— —规范运作》等法律法规、规范性文件的相关规定，对募集资金进行了专户存储 和专项使用，履行了必要的审议程序和相关信息披露义务，募集资金实际使用情 况与公司已披露情况一致，不存在违规使用募集资金的情况，亦不存在变相改变 募集资金用途和损害股东利益尤其是中小股东利益的情形。我们一致同意公司 《2023 年半年度募集资金存放与实际使用情况的专项报告》。 苏州泽璟生物制药股份有限公司 第二届董事会第九次会议文件 苏州泽璟生物制药股份有限公司独立董事 关于公司第二届董事会第九次会议相关事项的独立意见 根据《上市公司独立董事规则》《上海证券交易所科创板股票上市规则》《苏 州泽璟生物制药股份有限公司章程》《苏州泽璟生物制药股份有限公司独立董事 工作制度》等相关规定，我们作为苏州泽璟生物制药股份有限公司（以下简称" ...

（一）审议通过《关于公司<2023 年半年度报告>及摘要的议案》 经审议，监事会认为：公司《2023 年半年度报告》的编制和审议程序符合相 关法律法规及《公司章程》等内部规章制度的规定；公司《2023 年半年度报告》 的内容与格式符合相关规定，公允地反映了公司 2023 年半年度的财务状况和经 营成果等事项；半年度报告编制过程中，未发现公司参与半年度报告编制和审议 的人员有违反保密规定的行为；监事会全体成员保证公司《2023 年半年度报告》 披露的信息真实、准确、完整，不存在任何虚假记载、误导性陈述或重大遗漏， 并对其内容的真实性、准确性和完整性依法承担法律责任。 证券代码：688266 证券简称：泽璟制药 公告编号：2023-040 苏州泽璟生物制药股份有限公司 第二届监事会第九次会议决议公告 本公司监事会及全体监事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 一、监事会会议召开情况 苏州泽璟生物制药股份有限公司（以下简称"公司"）第二届监事会第九次 会议于 2023 年 8 月 25 日以现场表决方式在公司会议室召开。本次会议的通知于 2 ...

苏州泽璟生物制药股份有限公司 章 程 二〇二三年八月 | 第一章 | 总则 - | 1 - | | --- | --- | --- | | 第二章 | 经营宗旨和范围 - | 2 - | | 第三章 | 股份 - | 2 - | | 第一节 | 股份发行 - | 2 - | | 第二节 | 股份增减和回购 - | 4 - | | 第三节 | 股份转让 - | 6 - | | 第四章 | 股东和股东大会 - | 6 - | | 第一节 | 股东 - | 7 - | | 第二节 | 股东大会的一般规定 - | 9 - | | 第三节 | 股东大会的召集 - | 11 - | | 第四节 | 股东大会的提案与通知 - | 13 - | | 第五节 | 股东大会的召开 - | 14 - | | 第六节 | 股东大会的表决和决议 - | 17 - | | 第五章 | 董事会 - | 20 - | | 第一节 | 董事 - | 20 - | | 第二节 | 独立董事 - | 23 - | | 第三节 | 董事会 - | 26 - | | 第四节 | 董事会秘书 - | 30 - | | 第六章 | 总经理及其他高级管理人 ...

证券代码：688266 证券简称：泽璟制药 公告编号：2023-042 苏州泽璟生物制药股份有限公司 关于变更公司注册资本、修订《公司章程》 并办理工商变更登记的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 苏州泽璟生物制药股份有限公司（以下简称"公司"）于 2023 年 8 月 25 日召 开第二届董事会第九次会议，审议通过了《关于变更公司注册资本、修订<公司 章程>并办理工商变更登记的议案》。鉴于公司已完成向特定对象发行股票和 2021 年限制性股票激励计划首次授予部分第一个归属期的股份归属工作，公司 股份总数发生变更，需变更注册资本并对《公司章程》中的相应内容进行修订， 具体情况如下： 一、变更公司注册资本的相关情况 根据中国证券监督管理委员会《关于同意苏州泽璟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[2022]2649 号），公司向特定对象发 行股票新增股份2,448.9795万股，已于2023年4月21日在中国证券登记结算有限责 任公司上海分公司办理完毕股份登记手续。本次发行完成后， ...

证券代码：688266 证券简称：泽璟制药 公告编号：2023-041 苏州泽璟生物制药股份有限公司 2023 年半年度募集资金存放与实际使用情况 的专项报告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 一、募集资金基本情况 （一）2020 年首次公开发行 A 股股票募集资金 根据中国证券监督管理委员会 2019 年 12 月 31 日作出的《关于同意苏州泽 璟生物制药股份有限公司首次公开发行股票注册的批复》（证监许可[2019]2998 号），苏州泽璟生物制药股份有限公司（以下简称"公司"）获准向社会公开发行 人民币普通股 60,000,000 股，每股发行价格为 33.76 元（人民币，下同），募集 资金总额为人民币 2,025,600,000.00 元，扣除承销及保荐费用、发行登记费以及 累计发生的其他相关发行费用（共计人民币 117,379,245.32 元，不含税）后，募 集资金净额为人民币 1,908,220,754.68 元（以下简称"首发募集资金"），上述资金 已全部到位。信永中和会计师事务所（特殊普通 ...

本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示： ● 投资者可于 2023 年 5 月 16 日（星期二）至 5 月 22 日（星期一）16:00 前登录上证路演中心网站首页点击 "提问预征集"栏目或通过公司邮箱 zelgen01@zelgen.com 进行提问。公司将在说明会上对投资者普遍关注的问题进 行回答。 证券代码：688266 证券简称：泽璟制药 公告编号：2023-026 苏州泽璟生物制药股份有限公司 关于召开 2022 年度业绩说明会的公告 独立董事：张炳辉先生 （如有特殊情况，参会人员可能进行调整）。 苏州泽璟生物制药股份有限公司（以下简称"公司"）已于 2023 年 4 月 22 日 发布公司《2022 年年度报告》，为便于广大投资者更全面深入地了解公司 2022 年度经营成果、财务状况，公司计划于 2023 年 5 月 23 日下午 15:00-16:30 举行 2022 年度业绩说明会，就投资者关心的问题进行交流。 一、说明会类型 本次投资者说明会以视频录播结合网络文字互动形式召开，公司 ...

Financial Performance - The company's total revenue for Q4 2022 was 104,412,185.12 RMB, showing a significant increase compared to previous quarters[5]. - The net profit attributable to shareholders for Q4 2022 was -94,026,734.43 RMB, indicating continued losses but an improvement from earlier quarters[5]. - The operating cash flow for Q4 2022 was -89,435,019.31 RMB, reflecting ongoing cash outflows from operations[5]. - The company reported a total revenue of approximately ¥37,037,741.07, with a significant increase compared to ¥35,445,451.30 from the previous period, reflecting a growth of about 4.49%[118]. - The company reported a significant increase in revenue, reaching 1.2 billion yuan, representing a 25% year-over-year growth[136]. - The company reported a total revenue of 1.2 billion, representing a year-over-year growth of 15%[151]. - The company provided guidance for the next quarter, expecting revenue to be between 1.3 billion and 1.5 billion yuan, which translates to a growth rate of 8% to 25%[136]. - New product launches are anticipated to contribute an additional 200 million yuan in revenue over the next fiscal year[136]. Research and Development - The company has ongoing research projects, including the development of new drugs, which are crucial for future growth[19]. - The company’s R&D investment for the reporting period was 49,772.59 million RMB, remaining stable compared to the previous year, with a workforce of 324 R&D personnel, an increase of 4.18%[34]. - The company’s R&D investment amounted to 86,058.91 million RMB, representing 38.32% of its operating revenue[39]. - The R&D investment for the project "Donafenib for multiple indications" was 2,420.25 million RMB, showing a significant increase of 942.90% compared to the previous year[41]. - The company is focused on developing innovative drugs for oncology, bleeding, and immune-inflammatory diseases, aiming to improve the quality of life for patients in China[87]. - The company is committed to ongoing research and development of new products and technologies to enhance its market position[180]. - The company has established a robust R&D platform for complex recombinant proteins and antibody drugs, supporting its innovative drug development efforts[112]. Product Development and Pipeline - The company has established two core technology platforms for new drug development, focusing on small molecule drugs and complex recombinant protein biologics[34]. - As of December 31, 2022, the company has 17 major drugs in development, with 41 key projects, including 9 indications in new drug application or Phase III clinical trials[34]. - The company has developed multiple innovative drugs, including Donafenib tablets, which received NMPA approval for treating advanced hepatocellular carcinoma in June 2021 and for radioactive iodine-refractory differentiated thyroid cancer in August 2022[110]. - The company is actively expanding its pipeline with several drugs in different clinical trial phases, including treatments for severe alopecia and moderate-to-severe atopic dermatitis[111]. - The company aims to develop innovative drugs with independent intellectual property rights to meet the significant domestic and international pharmaceutical market demand[100]. Market and Sales Strategy - The company aims to establish partnerships with domestic and international pharmaceutical companies to expand its collaboration network[72]. - The company plans to accelerate the clinical development of its product pipeline, targeting unmet clinical needs in oncology and blood diseases, with a focus on Best-in-Class and First-in-Class drugs[87]. - The company is expanding its market presence in Southeast Asia, targeting a 15% market share by the end of 2024[136]. - The company is focused on maintaining independence and operational capability, ensuring no conflicts with controlling shareholders[109]. - The company has implemented a new digital marketing strategy aimed at increasing user engagement by 40%[136]. Financial Health and Governance - The overall financial health of the company remains strong, with a focus on sustainable growth and shareholder value enhancement[120]. - The company has implemented effective internal controls to ensure orderly business development during the reporting period[77]. - The company emphasizes the importance of cash flow in determining profit distribution, ensuring sustainable development[175]. - The company has a structured decision-making process for profit distribution, requiring approval from the board and shareholders[194]. - The company has established several specialized committees, including the audit committee and the strategic committee, to enhance governance[168]. Employee and Management - The company’s workforce increased by 22.53% year-on-year to 843 employees, including 324 in R&D and 303 in the commercial team, enhancing operational capabilities[103]. - The total remuneration for all directors, supervisors, and senior management personnel at the end of the reporting period amounted to CNY 13.7251 million[163]. - The company emphasizes employee training and development, focusing on enhancing skills and management capabilities[190]. - The company has implemented a stock incentive plan with 2,400,000 restricted stocks allocated to 272 individuals, representing 1% of the total stock[199]. Strategic Planning and Future Outlook - The company plans to continue investing in new product development and technology to maintain competitive advantage in the market[120]. - The management team expressed confidence in achieving a gross margin of 40% for the upcoming year, up from 35%[151]. - The company is considering strategic acquisitions to enhance its product portfolio, with a budget of 100 million allocated for potential deals[151]. - The company plans to implement a differentiated cash dividend policy based on its development stage and significant capital expenditure arrangements[177].

单位：元 币种：人民币 证券代码：688266 证券简称：泽璟制药 2023 年第一季度报告 重要内容提示 公司负责人、主管会计工作负责人及会计机构负责人（会计主管人员）保证季度报告中财务信息 的真实、准确、完整。 □是 √否 (一)主要会计数据和财务指标 | --- | --- | --- | |-----------------------------------------------|----------------|-----------------------| | 项目 | 本报告期 | 同期增减变动幅 度 (%) | | 营业收入 | 108,110,475.27 | 147.25 | | 归属于上市公司股东的净利润 | -57,227,635.33 | 不适用 | | 归属于上市公司股东的扣除非 经常性损益的净利润 | -63,921,861.10 | 不适用 | | 经营活动产生的现金流量净额 | -30,605,429.71 | 不适用 | | 基本每股收益（元/股） | -0.24 | 不适用 | 2023 年第一季度报告 | --- | --- | --- | --- | --- | ...

Financial Performance - The company's revenue for Q3 2022 was ¥92,492,835.06, representing a year-over-year increase of 64.67%[8] - The cumulative revenue for the year-to-date was ¥197,892,872.37, reflecting a 100.75% increase compared to the same period last year[8] - Total operating revenue for the first three quarters of 2022 reached ¥197,892,872.37, a significant increase from ¥98,578,591.59 in the same period of 2021, representing a growth of approximately 100.5%[35] - The company's operating revenue for the first three quarters of 2022 reached ¥236,412,440.22, a significant increase of 100.4% compared to ¥117,787,134.67 in the same period of 2021[59] - The net loss for the third quarter of 2022 was ¥387,326,926.68, compared to a net loss of ¥308,171,381.97 in the same quarter of 2021, showing an increase in losses of about 25.7%[38] - The net loss for the first three quarters of 2022 was ¥336,243,751.03, compared to a net loss of ¥274,524,146.75 in the same period of 2021, representing a decline of 22.4%[59] - The total comprehensive loss for the third quarter of 2022 was ¥381,175,502.95, compared to a loss of ¥309,139,327.19 in the previous year, indicating an increase of approximately 23.3%[40] Expenses and Costs - Research and development expenses totaled ¥137,107,979.55 in Q3 2022, accounting for 148.24% of revenue, a decrease of 100.24 percentage points compared to the same period last year[12] - Total operating costs for the first three quarters of 2022 were ¥617,167,804.62, up from ¥448,640,606.12 in 2021, indicating an increase of about 37.6%[35] - Research and development expenses amounted to ¥392,485,200.59 in the first three quarters of 2022, compared to ¥337,082,287.48 in 2021, reflecting a rise of approximately 16.4%[35] - The total operating costs for the first three quarters of 2022 were ¥48,844,500.60, up from ¥19,767,507.54 in the previous year, reflecting a growth of 146.5%[59] Assets and Liabilities - Total assets at the end of the reporting period were ¥1,632,982,796.46, down 6.47% from the previous year[12] - As of September 30, 2022, the company's total assets amounted to approximately ¥1.63 billion, a decrease from ¥1.75 billion at the end of 2021, reflecting a decline of about 6.5%[27] - The company's current assets totaled approximately ¥1.26 billion, down from ¥1.41 billion, indicating a decrease of around 10.2%[29] - The total liabilities of the company reached approximately ¥756.77 million, up from ¥492.88 million, indicating an increase of around 53.5%[33] - The total liabilities of the company as of the reporting date were ¥666,171,618.99, up from ¥434,421,857.67 in the previous year, reflecting a growth of 53.2%[54] Cash Flow - The company’s cash flow from operating activities was -¥280,907,547.95 year-to-date[12] - Operating cash inflow for the first three quarters of 2022 was CNY 316,518,316.19, a significant increase from CNY 119,775,624.60 in the same period of 2021, representing a growth of approximately 164.5%[46] - The net cash outflow from operating activities was CNY -280,907,547.95, an improvement compared to CNY -328,639,988.58 in the previous year[46] - Cash inflows from operating activities totaled ¥298,445,033.10 in the first three quarters of 2022, compared to ¥119,616,215.39 in the same period of 2021, marking an increase of 149.9%[62] Equity and Shareholder Information - The net profit attributable to shareholders was -¥116,736,319.76 for the quarter, with a cumulative net profit of -¥363,745,077.96 year-to-date[8] - The company's total equity attributable to shareholders of the parent company decreased to ¥843,297,105.59 from ¥1,196,323,124.03 year-over-year, a decline of about 29.5%[35] - The total equity decreased to ¥901,657,213.27 from ¥1,210,671,197.63 year-over-year, a decline of 25.5%[54] Product Development and Market Position - The company has only one product on the market, which is still in the early commercialization stage, necessitating continued investment in marketing and academic promotion[18] - The company has not reported any significant new product developments or market expansions during the reporting period[25] - The company’s R&D investment remains high as multiple innovative drugs are in critical trial phases[18]

Financial Performance - The company has not yet achieved profitability and has accumulated losses due to high R&D expenditures and ongoing market expansion efforts for its approved product, Donafenib tablets[5]. - As of June 30, 2022, the company raised a net amount of RMB 1,908.22 million during its IPO in January 2020, but still relies heavily on external financing for its working capital[6]. - The company is currently in the product development stage, with significant R&D costs impacting its financial performance and potential for future profitability[5]. - The company has no plans for profit distribution or capital reserve conversion during this reporting period[8]. - The company has not declared any cash dividends in the short term, which may negatively impact shareholder returns[5]. - The net profit attributable to shareholders was a loss of CNY 247.01 million, compared to a loss of CNY 176.97 million in the previous year, indicating an increase in losses by CNY 70.04 million[32]. - The company achieved operating revenue of CNY 105.40 million in the first half of 2022, a 148.53% increase compared to CNY 42.41 million in the same period last year[30]. - The company reported a basic earnings per share of -CNY 1.03, compared to -CNY 0.74 in the same period last year[31]. - The proportion of R&D investment to operating revenue was 242.29%, a decrease of 223.43 percentage points compared to the previous year[31]. - The company is facing potential cash flow pressures if operational expenses exceed available external financing, which may hinder its R&D and commercialization efforts[6]. Research and Development - The company emphasizes the importance of successful clinical trials and regulatory approvals for its pipeline products to achieve future profitability[5]. - The company has a focus on innovative drug development, particularly in the oncology sector, with ongoing research into targeted therapies[5]. - Research and development expenses for the first half of 2022 amounted to CNY 255.38 million, an increase of 29.30% year-on-year, reflecting the ongoing investment in multiple innovative drug candidates[32]. - The company has several innovative drugs in key trial stages, contributing to the increased R&D expenditures[32]. - The company is developing several new drugs targeting various conditions, including severe alopecia areata and moderate to severe atopic dermatitis, with ongoing clinical trials in China and the US[52][54]. - The company is focusing on expanding its product pipeline with innovative therapies for hematological malignancies and solid tumors, including drugs targeting JAK1/2/3 and KRAS G12C mutations[54][60]. - The company is actively pursuing market expansion strategies in both domestic and international markets, particularly in the US and China[52][54]. - The company is committed to advancing its research and development efforts to bring new therapies to market, addressing unmet medical needs in oncology[60]. - The company is leveraging its proprietary technology and partnerships to enhance its drug development capabilities and accelerate the clinical trial process[61]. - The company has established a robust platform for small molecule drug development and complex recombinant protein drugs, filling gaps in the domestic market[70]. Market and Competitive Landscape - The company is subject to intense competition in the pharmaceutical market, particularly for its approved drug Donafenib, which faces competition from both original and generic drugs[131]. - The company is in the early stages of market expansion and requires substantial investment in market development and academic promotion[146]. - The company faces risks related to pricing and market access, including potential delays in entering national medical insurance reimbursement lists, which could impact sales[123]. - Regulatory pressures may require the company to lower retail prices or limit reimbursement rates, affecting profitability[125]. - The company is exposed to risks related to international market operations, including potential adverse changes in legal policies and trade relations[138]. Clinical Trials and Approvals - The company has received clinical trial approvals for multiple drug candidates, including ZG19018 and ZG005, indicating ongoing development efforts[30]. - The company received approval for a new indication of Donafenib tablets for the treatment of progressive, locally advanced, or metastatic radioactive iodine-refractory differentiated thyroid cancer on August 10, 2022[60]. - The new indication approval was based on a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial, showing significant risk reduction in disease progression and improved progression-free survival compared to placebo[60]. - The clinical trial for JAK1, JAK2, JAK3, and TYK2 inhibitor, Jackatinib, achieved its primary endpoint in the Phase III trial for high-risk myelofibrosis, with a 43.2% SVR35 at 24 weeks[62]. - The company plans to submit new drug applications for Jackatinib for both high-risk myelofibrosis and for patients intolerant to ruxolitinib, accelerating the drug's market entry[62]. - The company is conducting Phase III clinical trials for recombinant human TSH for differentiated thyroid cancer, with no similar products currently available in the Chinese market[66]. - The company has received a total of 19 clinical trial notifications and drug approvals during the reporting period[74]. Financial Risks and Funding - The company relies heavily on external financing for operational funding, which poses a risk if cash flow from operations cannot be maintained[120]. - The company has faced significant cash flow deficits, with net cash flows from operating activities of -180.43 million, -343.86 million, -454.62 million, and -158.95 million for the years 2019, 2020, 2021, and the first half of 2022 respectively[134]. - The company’s drug, Donafenib, has been approved for commercialization but is still in the early stages, indicating that current product sales are insufficient to meet operational funding needs[134]. - The company’s future funding needs will depend on various factors, including the progress and costs of clinical trials and the outcomes of regulatory approvals[134]. - The company’s reliance on external funding sources is critical, as insufficient operational funds could lead to delays or cancellations of research and development projects[135]. Environmental Compliance - The company has implemented various pollution prevention facilities to ensure compliance with emission standards, including wastewater treatment facilities with a capacity of 48t/d and 20t/d[173]. - The company achieved compliance in the discharge of major pollutants, with COD levels at 17 mg/L against a limit of 430 mg/L[169]. - The company has established an emergency response plan for environmental incidents, filed with the Kunshan Environmental Protection Bureau[177]. - The company has not experienced any environmental pollution incidents or received administrative penalties during the reporting period[169]. - The company’s wastewater discharge is monitored online to ensure compliance with quality standards[175]. Shareholder Regulations - The company has committed to not transferring or managing shares held prior to the IPO for 36 months, with a maximum annual reduction of 2% of total shares after achieving profitability[181]. - The actual controller and key personnel have agreed to comply with shareholding and transfer regulations, ensuring transparency and timely reporting of share changes[184]. - The company has established a lock-up period of 6 months post-IPO, during which share transfers are restricted if the stock price falls below the issue price for 20 consecutive trading days[184]. - The company will comply with all relevant laws and regulations regarding shareholder holdings and share changes, ensuring integrity in fulfilling shareholder obligations[192].