中国国际金融股份有限公司 关于苏州泽璟生物制药股份有限公司 2023 年度持续督导工作现场检查报告 上海证券交易所： 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"泽璟制药"、"公司"）获准向社会公开发行人民币 普通股（A股）60,000,000股，每股面值人民币1元，发行价格为每股人民币33.76元，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。2020年1月23日，公司在上海证券交易所科创板挂牌上市。 根据中国证券监督管理委员会2022年11月3日作出的《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），公司于2023 年4月向特定对象发行人民币普通股（A股）24,489,795股，每股面值人民币1元，发行 价格为每 ...

[Table_Page] 年报点评|化学制药 | --- | --- | |----------------------------|------------| | | | | [ 公司评级 Table_Invest] | 买入 | | 当前价格 | 50.90 元 | | 合理价值 | 60.84 元 | | 前次评级 | 买入 | | 报告日期 | 2024-04-24 | -40% -30% -20% -10% 0% 10% 04/23 06/23 08/23 10/23 12/23 02/24 04/24 泽璟制药-U 沪深300 SAC 执证号：S0260520100005 lianfei@gf.com.cn 021-38003671 2024-02-25 [联系人： Table_Contacts]袁泉 021-38003838 ⚫ 聚焦肿瘤、出血、免疫等领域，创新步入收获期。根据 2023 年年报， 公司搭建了具备差异化竞争优势的在研管线：(1)多纳非尼和重组人凝 血酶已获批上市；(2)杰克替尼处于上市申请阶段，重组人促甲状腺激 素的 III 期临床已达到主要终点；(3)盐酸杰克替尼乳膏用于白癜风 ...

商业化稳步推进，期待杰克替尼上市 积极推进杰克替尼片新药上市审评，提前布局商业化工作。杰克替尼的中、高 危骨髓纤维化 NDA 申请已于 2022年 10月 16号获得受理，Ⅲ期试验显示杰克 替尼治疗中、高危骨髓纤维化 24周时脾脏体积较基线缩小≥35%的受试者比例 （SVR35）达 72.3%，与对照组羟基脲（17.4%）相比有效性和安全性优势明 显。针对杰克替尼片获批后的商业化工作，公司提前积极布局，在现有商业化 团队核心骨干架构的基础上，新增招聘擅长血液病领域的市场、医学和销售推 广的优秀人才。 | --- | --- | --- | --- | --- | |----------------------------|---------|---------|-------------------------------|-------------| | 指标 / 年度 | 2023A | 2024E | 2025E | 2026E | | 营业收入（百万元） | | | 386.44 859.98 1199.93 1869.85 | | | 增长率 | 27.83% | 122.54% | 39.53% ...

多个创新药逐渐进入商业化兑现阶段 后续产品管线潜力较高 多个创新药逐渐进入商业化兑现阶段。目前公司已有多纳非尼、 重组人凝血酶获批上市，在研产品中 JAK 抑制剂杰克替尼有望于 2024 年获批上市，重组人促甲状腺激已在 Pre-BLA 阶段，上述创 新药逐渐进入商业化兑现阶段。多纳非尼方面，其于 2023 年实现 3.84 亿元的销售额，同比增长 27.14%；重组人凝血酶方面，公司 已授权远大辽宁作为重组人凝血酶在大中华区的独家市场推广服 务商，考虑到远大辽宁在止血、麻醉镇痛及创面管理等领域的领 先地位，2024 年重组人凝血酶在国内的放量值得期待；杰克替尼 方面，骨髓纤维化适应症于 2022 年递交 NDA 申请有望于 2024 年 获批上市，重症斑秃 3 期已完成入组，中重度特应性皮炎和强直 性脊柱炎 3 期临床正在顺利推进中；重组人促甲状腺激素方面， 公司已向 CDE 递交 Pre-BLA 沟通交流申请。 | --- | --- | |------------|-------| | | | | | | | | | | 资料来源： | | | 升幅 % | | | 相对收益 | | | 绝对收益 | ...

泽璟制药（ [Table_StockNameRptType] 688266.SH） 公司研究/公司点评 | --- | --- | --- | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------ ...

科创板 688266.SH 2023年度社会责任报告 1 关于本报告 本报告是苏州泽璟生物制药股份有限公司（688266.SH，以下简称"泽璟制药"、"公司"或"我 们"）发布的2023年度社会责任报告。 编写依据 本报告参照上海证券交易所《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 相关法律法规及规范性文件的要求，结合公司所属行业特点以及报告期内公司履行社会责任的实际 情况进行编写。 报告范围 除非特别说明，本报告披露范围为泽璟制药及纳入合并财务报表的子公司。 时间范围 本报告的时间范围是2023年1月1日至2023年12月31日，为增强报告可比性及前瞻性，部分内容往 前后年度适度延伸。 数据说明 报告使用数据来源包括公司实际运行的原始数据、政府部门公开数据、年度财务数据、内部相关统 计报告等。本报告的财务数据以人民币为单位，若与财务报告不一致之处，以财务报告为准。 确认及批准 本报告于2024年4月19日获董事会通过。 2023年度社会责任报告 2 董事长致辞 尊敬的读者： 感谢您关注泽璟制药《2023年度社会责任报告》，我们将在报告中向您展示公司2023年度在履 行社会责任方面所做的 ...

证券代码：688266 证券简称：泽璟制药 公告编号：2024-016 苏州泽璟生物制药股份有限公司 2023 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）实际募集资金金额和资金到位时间 1、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（A 股）60,000,000 股，每股面值人民币 1 元，发行价格为每股人 民币 33.76 元，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"）， ...

根据《中华人民共和国公司法》《中华人民共和国证券法》《上市公司独立董 事管理办法》及《苏州泽璟生物制药股份有限公司章程》（以下简称"《公司章程》"） 《独立董事工作制度》的相关规定，本人张炳辉作为苏州泽璟生物制药股份有限 公司（以下简称"公司"）的独立董事，在 2023 年度的工作中，勤勉、尽责地履 行独董职责，主动了解公司生产经营情况，积极推动公司健康发展，切实维护了 公司和各位股东尤其是中小股东的利益。现将 2023 年度履职情况汇报如下： 苏州泽璟生物制药股份有限公司 2023 年度独立董事述职报告 一、独立董事的基本情况 张炳辉，本科学历，高级会计师。多年从事会计课教学、注册会计师和企业 财务工作。曾任职于山东省济宁市财政学校、山东省财政厅会计师事务所、国富 浩华会计师事务所、北京水木源华电器股份有限公司、北京东方惠尔图像技术有 限公司、北京中科科仪股份有限公司、北京深远瑞智投资管理有限责任公司，曾 担任杭州泰格医药科技股份有限公司独立董事、中交通力建设股份有限公司独立 董事、中电科安科技股份有限公司董事、北京尚睿通教育科技股份有限公司独立 董事、吉艾科技集团股份公司独立董事；现任成都康华生物制品股份 ...

Drug Development and Pipeline - The company has 14 major drugs in the pipeline, with multiple first-class new drugs (ZG0895, ZG2001, ZGGS15, and ZG006) approved for clinical trials in 2023[1] - The company has made significant progress in clinical trials for combination therapies involving Donafenib, including treatments for advanced solid tumors and various cancers[4] - The company has received multiple clinical approvals for combination therapies, enhancing its competitive edge in the oncology drug development field[3] - The company aims to leverage its dual advantages of small molecule targeted drugs and next-generation antibody products to maintain a leading position in the oncology market[4] - The company is actively advancing clinical trials for ZG005, a recombinant humanized anti-PD-1/TIGIT bispecific antibody, for various solid tumors[26] - The company is exploring clinical indications for ZG2001 tablets, which selectively inhibit SOS1 to treat various KRAS mutant solid tumors[28] - The company is exploring the development of bispecific and trispecific antibodies for various cancers, including liver cancer and non-small cell lung cancer, with a focus on expanding indications[46] - The company has several drugs in various stages of development, including JAK inhibitors and dual-specificity antibodies, which have received clinical trial approvals from regulatory authorities[157] Financial Performance - The company achieved operating revenue of RMB 386.44 million, a year-on-year increase of 27.83%, primarily due to the steady promotion of the Class 1 new drug Donafenib and an expanded market coverage[140] - The net profit attributable to shareholders was a loss of RMB 278.58 million, a year-on-year decrease in loss of RMB 178.75 million (adjusted), with a weighted average return on net assets of -20.00%, a decrease of 26.31 percentage points in loss year-on-year (adjusted)[140] - Total assets at the end of the reporting period were RMB 2.89 billion, a year-on-year increase of 73.06% (adjusted), and equity attributable to the parent company was RMB 1.63 billion, a year-on-year increase of 115.10% (adjusted)[141] - The company reported a net cash flow from operating activities of -RMB 232.75 million, an improvement compared to -RMB 370.34 million in the previous year[171] - The company has not generated sales revenue from recently approved products due to ongoing investments in team expansion and market development[152] Research and Development - The total R&D expenditure for the current year is ¥496,329,685.86, a slight decrease of 0.28% compared to the previous year[58] - The ratio of total R&D expenditure to operating income is 128.44%, down by 36.20 percentage points from 164.64% in the previous year[58] - The company has established a comprehensive new drug R&D system and platforms for small molecule drugs and complex recombinant proteins, enhancing its core competitiveness in drug discovery[73] - The company has a strong R&D and business development team with international experience, facilitating opportunities for partnerships and licensing[76] - The company is investing significantly in R&D for new drug candidates, but there is uncertainty regarding the successful identification and development of these candidates, which could affect its future business prospects[126] Market Position and Strategy - The company is focusing on differentiated competitive advantages in its product pipeline, particularly in oncology and immunotherapy, to strengthen its market position[2] - The company has entered into an exclusive commercialization agreement with Yuan Da Life Sciences Group for the promotion of recombinant human thrombin in Greater China[1] - The company is committed to addressing unmet clinical needs in various therapeutic areas, including oncology, bleeding and blood diseases, and immune-inflammatory diseases[1] - The company has been recognized in multiple rankings, including being listed as one of the top 30 innovative small molecule drug companies in China and ranked first in the 2023 China Pharmaceutical Innovation Enterprises list[37] Risks and Challenges - The company faces significant risks related to cash flow, which could adversely affect product development and commercialization progress[96] - The competitive landscape in the pharmaceutical market is intense, with existing approved drugs and generics posing challenges in market penetration and pricing strategies, particularly for its late-stage products[117] - The company is heavily reliant on external financing to meet its operational funding needs, as current product sales do not suffice, which may lead to delays or cancellations of R&D projects if sufficient capital is not secured[120] - The company faces significant risks in drug development, including potential delays or failures in obtaining regulatory approvals for its pipeline products, which could adversely impact its business operations[116] Clinical Trials and Approvals - The company has received clinical trial approvals for multiple products, including ZG006, ZG2001, and ZG0895 from the National Medical Products Administration and FDA[50] - The company is advancing the Phase III clinical trial for rhTSH, which has met its primary endpoint, and is expediting the product's market application process[193] - The clinical research for ZG006, a first-in-class tri-specific antibody, is progressing well and is among the global leaders in its category[195] Product Commercialization - Donafenib tablets have been approved for first-line treatment of advanced hepatocellular carcinoma and for radioactive iodine-refractory differentiated thyroid cancer, included in the medical insurance directory[81] - Recombinant human thrombin, the only product in China produced using recombinant gene technology, was approved for market in December 2023, demonstrating high efficiency in hemostasis[81] - The commercial promotion of the Class 1 new drug Donafenib tablets is progressing steadily, contributing to increased sales and market expansion[173] Future Outlook - The company has a strong pipeline with multiple products showing promising results in clinical trials, indicating a robust future outlook for market expansion and new product development[81] - The company's future funding needs will depend on various factors, including the progress and costs of clinical trials and the regulatory approval of drug candidates[134] - The company has outlined various risks and countermeasures in its annual report, emphasizing the importance of understanding these risks for investors[159]

（一）日常关联交易履行的审议程序 中国国际金融股份有限公司 关于苏州泽璟生物制药股份有限公司 2024 年度日常关联交易预计的核查意见 中国国际金融股份有限公司（以下简称"中金公司"、"保荐机构"）作为苏州泽璟生 物制药股份有限公司（以下简称"泽璟制药"、"公司"）持续督导的保荐机构，根据《上 海证券交易所科创板股票上市规则》《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》《上海证券交易所上市公司自律监管指引第 11 号——持续督导》等 相关法律、法规和规范性文件的规定，对泽璟制药 2024 年度日常关联交易预计事项进 行了核查，核查情况如下： 一、日常关联交易基本情况 公司于 2024 年 4 月 19 日召开第二届董事会审计委员会第十次会议，审议通过了 《关于公司 2024 年度日常关联交易预计的议案》。 公司于 2024 年 4 月 19 日召开第二届董事会第一次独立董事专门会议，审议通过了 《关于公司 2024 年度日常关联交易预计的议案》。经审议，全体独立董事认为：公司本 次关于 2024 年度日常关联交易的预计事项为基于公司正常经营和业务发展需要，按照 自愿、平等、互利的原则进行 ...