[Table_Profit] 基本状况 总股本(百万股) 213.18 流通股本(百万股) 146.37 市价(元) 55.49 市值(百万元) 11,829.36 流通市值(百万元) 8,122.07 请务必阅读正文之后的重要声明部分 请务必阅读正文之后的重要声明部分 - 2 - 公司点评 Email：cuisy@zts.com.cn ◼ 公司在研新药项目全为自主研发项目，新药研发具有高投入、高风险、 长周期等特点，公司新药研发进展存在不确定性风险。另外，公司在研 新药项目多数都有竞争品种在研或已上市，同类竞争加剧或者项目进度 不达预期可能会给公司新药研发项目转让带来不确定性风险。 来源：公司公告,中泰证券研究所 来源：公司公告,中泰证券研究所 公司点评 本报告基于本公司及其研究人员认为可信的公开资料或实地调研资料，反映了作者的研究观点，力求独立、客 观和公正，结论不受任何第三方的授意或影响。本公司力求但不保证这些信息的准确性和完整性，且本报告中 的资料、意见、预测均反映报告初次公开发布时的判断，可能会随时调整。本公司对本报告所含信息可在不发 出通知的情形下做出修改，投资者应当自行关注相应的更新或修改。本报 ...

Investment Rating - The report maintains a "Recommended" rating for the company [1][8]. Core Insights - The company achieved a revenue of 1.034 billion yuan in 2023, representing a year-on-year growth of 58.69%, and a net profit attributable to shareholders of 163 million yuan, up 26.20% year-on-year [1]. - The self-selected business segment saw significant growth, with revenue reaching 629 million yuan, a 145.48% increase year-on-year, and a gross margin improvement of 3.27 percentage points to 64.43% [1]. - The company has established a robust product pipeline that meets international standards and has made substantial progress in business development, securing multiple strategic partnerships in the GLP-1 sector [1]. - The company has overcome technical bottlenecks in large-scale production of long-chain peptides, achieving production capabilities of over 10 kilograms per batch, which positions it as a leader in the industry [1]. - Future revenue projections for 2024, 2025, and 2026 are estimated at 1.442 billion, 2.006 billion, and 2.828 billion yuan, respectively, with corresponding year-on-year growth rates of 39.5%, 39.1%, and 41.0% [1]. Summary by Sections Financial Performance - In Q4 2023, the company reported a revenue of 324 million yuan, a 20.45% increase year-on-year, while the net profit attributable to shareholders decreased by 6.17% to 71 million yuan [1]. - The company’s EBITDA for 2023 was 338 million yuan, with projections for 2024, 2025, and 2026 at 458 million, 619 million, and 833 million yuan, respectively [15]. Business Development - The company has secured 16 domestic registrations and 12 US DMF/VMF numbers for its raw materials, with significant partnerships for the supply of GLP-1 innovative drug raw materials [1]. - The company’s third-generation peptide production facility has commenced operations, with plans to expand production capacity to meet global demand for GLP-1 peptide raw materials by the end of 2025 [1]. Market Position - The company is recognized as a leader in the peptide sector in China, with a strong quality system and large-scale production capabilities, indicating a promising outlook for continued high growth in performance [1].

Business Development and Market Strategy - The company has established a matrix business development team to systematically promote global sales, focusing on the international market for APIs and CDMO services[14]. - The company expects to engage in bidding for bulk procurement projects, leveraging cost advantages from integrated API and formulation production[14]. - The company plans to steadily advance the launch of products with significant global market demand based on its domestic market foundation[14]. - The company’s sales network is being actively built, focusing on leveraging distributors with strong marketing capabilities[14]. - The company has developed a stable cooperation relationship with renowned pharmaceutical companies such as Gilead and Incyte, providing custom R&D and production services for complex pharmaceutical intermediates[25]. - The company is actively pursuing market expansion through new product launches and regulatory approvals, aiming to strengthen its competitive position in the pharmaceutical industry[92]. Financial Performance - The company achieved a total revenue of 103,646 million RMB, with a net profit of 7,241.71 million RMB, and an operating profit of 15,146.03 million RMB[99]. - The company reported a 79.77% increase in expensed R&D investment compared to the previous year, amounting to approximately ¥124.89 million[48]. - The proportion of R&D investment to operating income decreased to 12.93%, down by 2.08 percentage points from the previous year[48]. - The company has ongoing projects for new drug formulations, including a collaboration on atorvastatin calcium tablets[46]. - The company has received approval for multiple products, including Injection Bevacizumab and Amlodipine Atorvastatin Calcium Tablets, indicating successful product development and regulatory compliance[92]. Research and Development - The company achieved a total R&D investment of approximately ¥133.63 million, representing a year-on-year increase of 36.68%[48]. - The number of R&D personnel increased to 266, representing 17.22% of the total workforce, up from 15.17% in the previous period[99]. - R&D expenses accounted for over 10% of the company's revenue for the past three years, indicating a strong commitment to innovation[101]. - The company has established a comprehensive structural characterization technology platform for oligonucleotides, enhancing product quality control[43]. - The company has developed a risk assessment system for compatibility studies, ensuring efficient and precise development of formulations[41]. Product Development and Regulatory Compliance - The company has obtained domestic registration for 16 raw material drug varieties and 7 formulation varieties, with 12 raw material drug varieties receiving FDA DMF/VMF numbers[25]. - The company is in the registration application phase for several products, including Acetylcysteine Injection and Atosiban Injection, which are expected to enhance the product portfolio[92]. - The company has several products in various stages of development, including Phase III clinical trials for Brivaracetam Tablets and BE trials for Epalrestat Tablets, indicating a robust pipeline[92]. - The company has submitted applications for four formulations and five raw materials, currently under review by the CDE[182]. Market Trends and Growth Projections - The global pharmaceutical market is projected to grow from $1.4 trillion in 2021 to nearly $1.8 trillion by 2026, with a compound annual growth rate of 3%-6% from 2022 to 2026[17]. - The global CDMO market size increased from $39.4 billion in 2017 to $63.2 billion in 2021, with a CAGR of 12.5%, and is expected to reach $124.3 billion by 2025[21]. - The global pharmaceutical R&D investment is expected to reach $213 billion by 2024, with a CAGR of 3% from 2018 to 2024[18]. - The global peptide drug market is expected to expand significantly due to increasing clinical applications and new drug launches, particularly in chronic disease treatment[21]. Operational and Compliance Issues - The company has not faced any major litigation or arbitration matters during the reporting period[9]. - The company has not encountered any non-compliance issues or risks of delisting[9]. - The company has no external guarantees outstanding, maintaining a guarantee balance of zero at the end of the reporting period[59]. - The company is facing operational risks due to the uncertainty in the commercialization of its self-developed products and the competitive landscape[107]. Investment and Capital Structure - The total amount of funds raised from the initial public offering was approximately ¥829.82 million, with a net amount of ¥725.16 million after deducting issuance costs[72]. - The company plans to issue convertible bonds on December 21, 2023, with a total amount of ¥434 million[72]. - The company has committed to invest a total of ¥150 million in the Hangzhou Ausino Pharmaceutical Intermediate Construction Project, with a cumulative investment of ¥119.62 million, achieving a progress rate of 79.75%[76]. - The company has a total of 20,000,000 shares under lock-up conditions held by Lianyungang Nuotai Investment Management Partnership, which can be traded after 36 months from the listing date[154]. Sales and Marketing - The sales revenue of the company's raw materials is influenced by the progress of downstream formulation manufacturers' R&D and registration processes, resulting in volatility in sales[107]. - The company’s revenue from overseas sources is significant, and fluctuations in the RMB to USD exchange rate may impact operating performance and pricing competitiveness[108]. - The total sales expenses for the reporting period amounted to RMB 57,625,300, representing 5.58% of operating income[192]. - Sales expenses increased by 64.80% year-on-year, primarily due to the growth in sales personnel salaries, equity incentive costs, and commission and marketing expenses[192].

Investment Rating - The report upgrades the investment rating of the company to "Buy" [1][3]. Core Views - The company reported a revenue of 1.034 billion RMB for 2023, representing a year-on-year growth of 58.69%, and a net profit attributable to shareholders of 163 million RMB, up 26.20% year-on-year [2][3]. - The strong growth in both formulation and peptide raw materials indicates significant future order potential, with self-developed product revenue reaching 629 million RMB, a 145.48% increase year-on-year [3]. - The company has 37 ongoing projects, including 21 raw material projects and 16 formulation projects, with 12 raw materials having obtained US DMF/VMF numbers [3]. - Key future orders include collaborations with notable biopharmaceutical companies for GLP-1 innovative drug raw materials and a long-term supply contract worth 102 million USD with a large European pharmaceutical company [3]. - The company has overcome technical bottlenecks in large-scale production of long-chain peptide drugs and established a production technology platform, achieving industry-leading production capabilities [3]. Summary by Sections Performance - In 2023, the company achieved a revenue of 1.034 billion RMB, a 58.69% increase from the previous year, and a net profit of 163 million RMB, reflecting a 26.20% year-on-year growth [2][3]. - The adjusted revenue forecasts for 2024 and 2025 are 1.287 billion RMB and 1.681 billion RMB, respectively, with an expected revenue of 2.269 billion RMB in 2026 [3]. Business Development - The company has established a strong pipeline with 37 projects, including significant advancements in peptide and small nucleic acid production capabilities [3]. - The successful acquisition of FDA First Adequate Letters for key raw materials supports the company's growth strategy in meeting regulatory requirements for downstream formulation clients [3]. Profitability Forecast - The report projects a net profit of 204 million RMB for 2024, 267 million RMB for 2025, and 388 million RMB for 2026, indicating robust growth potential [3].

地址：深圳市福田区福华三路 100 号鼎和大厦 24 楼 邮编：518033 诺泰生物（688076.SH） | --- | --- | |-------------------------------|-----------| | | | | | | | 买入（维持） | | | 股票信息 | | | 行业 | 医疗服务 | | 前次评级 | 买入 | | 3 月 28 日收盘价 ( 元 ) | 55.49 | | 总市值 ( 百万元 ) | 11,829.57 | | 总股本 ( 百万股 ) | 213.18 | | 其中自由流通股 (%) | 68.66 | | 30 日日均成交量 ( 百万股 ) | 3.70 | | 股价走势 | | 分析师 张金洋 执业证书编号：S0680519010001 邮箱：zhangjy@gszq.com 分析师 胡偌碧 执业证书编号：S0680519010003 邮箱：huruobi@gszq.com 研究助理 陶宸冉 执业证书编号：S0680123070012 邮箱：taochenran@gszq.com 请仔细阅读本报告末页声明 免责声明 2024 年 03 月 29 ...

江苏诺泰澳赛诺生物制药股份有限公司 2023年度独立董事述职报告（徐强国） 本人徐强国作为江苏诺泰澳赛诺生物制药股份有限公司（以下简称"公 司"）的独立董事，严格按照《公司法》、《证券法》、《上市公司独立董事管 理办法》、《上市公司治理准则》等法律法规及《公司章程》的规定，保持独立 性，忠实、勤勉地履行职责。在 2023 年度工作中，全面关注公司发展战略，了 解公司经营状况，积极出席股东大会、董事会等相关会议，认真审议各项议案， 并就重大事项发表独立意见，切实维护公司和中小股东的合法权益，促进公司规 范运作。现就 2023 年度履职情况汇报如下： 一、独立董事的基本情况 公司第三届董事会由 11 名董事组成，其中独立董事 4 名，占董事会成员的 三分之一以上，符合相关法律法规及公司制度的规定。 （一）个人工作履历、专业背景以及兼职情况 徐强国，男，1964 年 9 月出生，中国国籍，无境外永久居留权。1980 年 9 月至 1984 年 6 月，就学于杭州商学院会计学专业，获学士学位；1984 年 8 月至 2010 年 6 月，在天津商业大学商学院财务管理系工作，其间于 2002 年 9 月至 2007 年 ...

江苏诺泰澳赛诺生物制药股份有限公司 关于 2023 年度会计师事务所履职情况评估及 审计委员会履行监督职责情况的报告 （一）会计师事务所基本情况 中天运会计师事务所（特殊普通合伙）始建于 1994 年 3 月，2013 年 12 月完 成转制，取得《北京市财政局关于同意设立中天运会计师事务所（特殊普通合伙） 的批复》（京财会许可[2013]0079 号）。组织形式：特殊普通合伙。注册地址： 北京市西城区车公庄大街 9 号院 1 号楼 1 门 701-704。首席合伙人为刘红卫先生。 截至 2022 年末，中天运拥有合伙人 68 人，注册会计师 415 人，签署过证券服务 业务审计报告的注册会计师 193 人。 （二）聘任会计师事务所履行的程序 公司于 2023 年 8 月 28 日召开第三届董事会第十三次会议，审议通过了《 关于续聘会计师事务所的议案》，并经公司于 2023 年 11 月 7 日召开的 2023 年 第一次临时股东大会批准，同意续聘中天运会计师事务所（特殊普通合伙）为 公司 2023 年度审计机构。公司独立董事对续聘事项进行了事前认可，并发表了 明确同意的独立意见。 二、2023 年年审会计师 ...

中天运会计师事务所(特殊普通合伙)JONTEN CPAS 江苏诺泰澳赛诺生物制药股份有限公司 募集资金存放与使用情况的 专项报告 中天运[2024]核字第 90041 号 中天运会计师事务所 (特殊普通合伙) JONTEN CERTIFIED PUBLIC ACCOUNTANTS LLP 中天运会计师事务所(特殊普通合伙)JONTEN CPAS 製 | 1、 募集资金年度存放与使用情况鉴证报告 | | --- | | 2、 募集资金使用及存放情况的专项报告 | | 3、 募资资金使用情况对照表 . | | 4、 事务所营业执照复印件 . | | 5、 事务所执业证书复印件 ……………………………………………………………………17 → | | 6、 签字注册会计师资质证明复印件 | 中天运会计师事务所(特殊普通合伙)JONTEN CPAS 江苏诺泰澳赛诺生物制药股份有限公司 募集资金年度存放与使用情况鉴证报告 中天运会计师事务所(特殊普通合伙) 中天运[2024]核字第 90041周 音 江苏诺泰澳赛诺牛物制药股份有限公司全体股东: 我们接受委托,对后附的江苏诺泰澳赛诺生物制药股份有限公司 (以下简称" 贵公司 ...

中天运会计师事务所（特殊普通合伙）JONTEN CPAS 江苏诺泰澳赛诺生物制药股份有限公司 内部控制审计报告 中天运[2024]控字第 90006 号 中天运会计师事务所 (特殊普通合伙) JONTEN CERTIFIED PUBLIC ACCOUNTANTS LLP 中天运会计师事务所(特殊普通合伙)JONTEN CPAS 录 | 1、内部控制审计报告 | | --- | | 2、内部控制评价报告 | | 3、事务所营业执照复印件 ……………………………………………….8 | | 4、事务所执业证书复印件 . | | 5、签字注册会计师资质证明复印件 . | 中天运会计师事务所（特殊普通合伙）JONTEN CPAS 云 内部控制审计报告 中天运会计师事务所(特殊普通合伙) 中天运[2024]控穿第90006 号 江苏诺泰澳赛诺生物制药股份有限公司全体股东: 我们的责任是在实施审计工作的基础上,对财务报告内部控制的有效 性发表审计意见,并对注意到的非财务报告内部控制的重大缺陷进行披露。 三、内部控制的固有局限性 内 部 控 制 具 有 固 有 局 限 性 , 存 在 不 能 防 止 和 发 现 错 报 的 ...

公司代码：688076 公司简称：诺泰生物 转债代码：118046 转债简称：诺泰转债 江苏诺泰澳赛诺生物制药股份有限公司 2023 年度内部控制评价报告 江苏诺泰澳赛诺生物制药股份有限公司全体股东： 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， 根据内部控制评价结果推测未来内部控制的有效性具有一定的风险。 二. 内部控制评价结论 1. 公司于内部控制评价报告基准日，是否存在财务报告内部控制重大缺陷 □是 √否 2. ...