Investment Rating - The report initiates coverage with a "Buy" rating [4]. Core Insights - The company achieved a revenue growth of 58.69% in 2023, driven primarily by its self-selected products, which saw a remarkable increase of 145.5% in revenue [2][7]. - The company’s gross margin improved to 60.97%, reflecting a 3.4 percentage point increase, while the net profit margin was 15.58%, down 4.24 percentage points due to high non-recurring gains in 2022 [24][32]. - The company is positioned as a leading player in the peptide raw material market, with significant advancements in production capabilities and a focus on expanding its product pipeline [36][47]. Financial Performance - In 2023, the company reported total revenue of 1.034 billion yuan, with a net profit of 163 million yuan, marking a 26.2% increase [7][23]. - The fourth quarter of 2023 saw a revenue of 324 million yuan, representing a 20.45% year-on-year growth [7][23]. - The company expects revenue growth projections of 36%, 33%, and 27% for 2024, 2025, and 2026, respectively, with net profits anticipated to grow at 35%, 40%, and 33% during the same period [25][26]. Business Segments - The self-selected products segment generated 629 million yuan in revenue, with a significant contribution from antiviral formulations, particularly oseltamivir, which saw a revenue increase of 647.5% [3][8]. - Custom products and technical services maintained stable growth, achieving revenue of 404 million yuan, up 3.1% [3][8]. Market Position and Strategy - The company has adopted a matrix business development model to enhance its market share, achieving breakthroughs in external collaborations and orders in 2023 [14][15]. - Strategic partnerships have been established, including a long-term supply contract worth 102 million USD for CDMO services with a major European pharmaceutical company [15][18]. Research and Development - The company emphasizes R&D, with a workforce of 1,545 employees, including 266 in technical R&D, reflecting a 57.4% increase in R&D personnel [22][32]. - The company has made significant investments in expanding its production capabilities, particularly in peptide synthesis technologies, achieving industry-leading production levels [47][49].

数据来源：公司公告，药融云，NMPA，CDE，FDA，丁香园，国泰君安证券研究，注："合作"为公司合作申报，"转让"为 | --- | --- | --- | --- | |-------------------------|-------------------------------------------------------------------|---------------------------------------|------------| | 9 \n药品名称 | 多肽药物为主，多适应症布局，研发成果有望多点开花（截至 \n应用前景 | 2024 年 4 月） \n国内获批适应症 | \n国内进度 | | 利拉鲁肽注射液 （合作） | 糖尿病、减肥 | Ⅱ 型糖尿病治疗 | 补充研究 | | 司美格鲁肽注射液 | | | 中试 | | --- | --- | --- | --- | |---------------------------------|----------|---------------------------------------------|---------- ...

南京证券股份有限公司 关于江苏诺泰澳赛诺生物制药股份有限公司 2023 年度持续督导报告书 根据《证券发行上市保荐业务管理办法》和《上海证券交易所上市公司自律监 管指引第 11 号——持续督导》等有关法律、法规的要求，南京证券股份有限公司 （以下简称"南京证券"或"保荐机构"）作为江苏诺泰澳赛诺生物制药股份有限 公司（以下简称"诺泰生物"或"公司"）持续督导工作的保荐机构，负责诺泰生 物上市后的持续督导工作，并出具本持续督导报告书。 一、持续督导工作情况 | 序号 | 工作内容 | 持续督导情况 | | --- | --- | --- | | 1 | 建立健全并有效执行持续督导工作制度，并针 | 保荐机构已建立并有效执行了 | | | | 持续督导制度，并制定了相应的 | | | 对具体的持续督导工作制定相应的工作计划。 | 工作计划。 | | 2 | 根据中国证监会相关规定，在持续督导工作开 | 保荐机构已与诺泰生物签订保 | | | 始前，与上市公司或相关当事人签署持续督导 | 荐协议，该协议明确了双方在持 | | | 协议，明确双方在持续督导期间的权利义务， | 续督导期间的权利和义务，并报 | | | ...

446 | --- | --- | --- | --- | --- | |--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|--------------------|------------------------|----------------| | 2024 年 04 月 03 日 \n诺泰生物（ 688076.SH ） | | | 公司研究●证券研究报告 | 公司快报 | | | | | 医药 \| | 生物医药Ⅲ | | 自主选择产品贡献高增量，产能+BD 持续拓展 | 投资评级 | | 买入-A(维持 | ) | | 投资要点 | 股价 (2024-04-03) | | | 53.53 元 | | 事件：公司陆续发布 2023 年年报及 2024Q1 业 ...

Investment Rating - The report maintains a "Buy" rating for the company, indicating a positive outlook for the stock price relative to the market index [7]. Core Insights - The company's performance significantly exceeded expectations, with a revenue of 1.034 billion yuan in 2023, representing a year-on-year growth of 58.7%. The net profit attributable to shareholders was 163 million yuan, up 26.2% year-on-year, while the non-recurring net profit grew by 102.3% [5][8]. - The company is accelerating capacity expansion, with several projects coming online, including a multi-peptide raw material drug production facility and a solid dosage form production facility, which will enhance its CDMO and production capabilities [6][8]. - The self-selected products, particularly peptides and formulations, are experiencing rapid growth, with revenues from self-selected products reaching 629 million yuan, a 145.5% increase year-on-year [7][8]. Summary by Sections Financial Performance - In 2023, the company achieved a total revenue of 1,033.55 million yuan, with a year-on-year growth rate of 58.69%. The net profit attributable to shareholders was 162.94 million yuan, reflecting a growth of 26.2% [12]. - The gross profit margin improved to 68.05% in 2023, up from previous years, indicating better cost management and pricing power [12]. Capacity Expansion - The company has successfully launched several production facilities, including a multi-peptide raw material drug production facility and a solid dosage form production facility, which are expected to significantly increase production capacity by 2025 [6][8]. - The new facilities will support the transition of research and development processes to commercial production, enhancing the company's competitive edge in the market [6]. Research and Development - The company has a robust pipeline with 37 projects under development, including 21 raw material drug projects and 16 formulation projects. It has also secured FDA approvals for several key products [8]. - The R&D team has expanded significantly, with 266 personnel and an R&D investment of 134 million yuan, accounting for 12.93% of total revenue, which is above industry standards [8]. Business Development - The business development team has strengthened its presence in key markets, including Europe and Latin America, and has secured several strategic partnerships with major pharmaceutical companies [9]. - Notable contracts include a long-term supply agreement worth 102 million USD with a large European pharmaceutical company, set to commence in 2024 [9].

Investment Rating - The report assigns a "Buy" investment rating for the company, marking its first coverage [8][27]. Core Insights - The company achieved significant revenue growth in 2023, with total revenue reaching 629 million yuan, a year-on-year increase of 145.48%, driven by strong demand for raw materials and flu medications [6][23]. - The company is positioned as a key supplier for GLP-1 peptide drugs, with the FDA First Adequate Letter for semaglutide, which is expected to enhance its performance as formulation demand grows [27]. - The company has established strategic partnerships and contracts, including a long-term supply contract worth 102 million USD with a major European pharmaceutical company, set to begin in 2024 [48]. Financial Summary - The company reported revenues of 1.034 billion yuan in 2023, with projections of 1.41 billion yuan, 2.02 billion yuan, and 2.88 billion yuan for 2024, 2025, and 2026 respectively, reflecting growth rates of 36.4%, 43.3%, and 42.6% [12][28]. - Net profit for 2023 was 165 million yuan, with forecasts of 232 million yuan, 370 million yuan, and 445 million yuan for the following three years, indicating growth rates of 42.4%, 59.6%, and 20.1% [12][28]. - The earnings per share (EPS) are projected to be 1.09 yuan, 1.74 yuan, and 2.09 yuan for 2024, 2025, and 2026, respectively [12][28].

证券代码：688076 证券简称：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 投资者关系活动记录表 编号：2024-001  特定对象调研  分析师会议  媒体采访 投资者关系活动  业绩说明会  新闻发布会  路演活动 类别  现场参观  其他 中泰证券、中金公司、申万宏源、国信证券、国盛证券、浙商证 参与单位名称及 券、东海证券、开源证券、国金证券、民生证券、广发证券、东 人员姓名 方证券及网上投资者 时间 2024年3月29日10:00-11:00 地点 电话会议 ...

[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].