证券研究报告|公司点评报告 [Table_Date] 2024 年 09 月 05 日 [Table_Title] 24 年 Q2 业绩环比增长，海外制剂未来可期 [Table_Title2] 健友股份(603707) [Table_Summary] 事件概述 公司公告 2024 年中报：2024 年 H1 公司实现营业收入 21.43 亿 元（yoy-6.99%），归母净利润 4.05 亿元（yoy-35.15%），扣非归 母净利润 3.69 亿元（yoy-39.70%）。2024 年 Q2 公司实现营业收 入 11.38 亿元（yoy+14.27%,qoq+13.35%），归母净利润 2.28 亿 元（yoy-22.02%, qoq+28.58%），扣非归母净利润 1.97 亿元 （yoy -29.97%, qoq+15.11%）。 ►肝素原料药：收入占比持续降低，价格周期性波动影响 有望减弱 24H1 公司原料药业务收入为 5.33 亿元，占总营收 24.85%。公司 肝素原料药业务占总营收的比例从 2019 年占超过六成到 2024 年 上半年占二成。原料药板块收入占比持续下滑主要系肝素价格下 降所致 ...

公司点评报告 · 医药行业 Q2 业绩环比改善，海外非肝素制剂快速放量 —— 2024 年中报业绩点评 2024 年 9 月 2 日 | --- | --- | --- | --- | |-------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|------------------------------| | ...

南京健友生化制药股份有限公司 关于召开 2024 年半年度业绩说明会的公告 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、准确性和完整性承担个别及连带责任。 重要内容提示： https://roadshow.sseinfo.com/） 投资者可于 2024 年 09 月 18 日(星期三) 至 09 月 24 日(星期二)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 nkf-pharma@nkf-pharma.com.cn 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。 南京健友生化制药股份有限公司（以下简称"公司"）于 2024 年 8 月 31 日 发布公司 2024 年半年度报告，为便于广大投资者更全面深入地了解公司 2024 年半年度经营成果、财务状况，公司计划于 2024 年 09 月 25 日(星期三) 上午 09:00-10:00 举行公司 2024 年半年度业绩说明会，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网络文字互动形式召开，公司将针对 2024 年半年度的 经营 ...

Financial Performance - The company's operating revenue for the first half of 2024 was ¥2,142,658,737.40, a decrease of 6.99% compared to ¥2,303,732,565.40 in the same period last year[18]. - The net profit attributable to shareholders of the listed company was ¥405,017,591.60, down 35.15% from ¥624,500,188.97 in the previous year[18]. - The net profit attributable to shareholders after deducting non-recurring gains and losses was ¥368,651,769.63, a decrease of 39.70% compared to ¥611,326,661.20 in the same period last year[18]. - The net cash flow from operating activities was ¥606,437,423.32, a slight decrease of 3.80% from ¥630,364,246.90 in the previous year[18]. - Basic earnings per share decreased by 35.90% to CNY 0.25 compared to the same period last year[19]. - Diluted earnings per share decreased by 34.21% to CNY 0.25 compared to the same period last year[19]. - The weighted average return on equity decreased by 2.72 percentage points to 6.91% compared to the same period last year[19]. - The company reported a loss of CNY 9,294,095.61 from fair value changes of financial assets and liabilities[21]. - The company received government subsidies amounting to CNY 44,125,446.97 during the reporting period[21]. Market Trends and Opportunities - The global pharmaceutical expenditure is projected to reach approximately USD 2.2 trillion by 2028, growing at a CAGR of 6.6% from 2024 to 2028[22]. - The global generic drug market is expected to reach USD 497 billion in sales by 2025, driven by increasing demand and patent expirations[22]. - The global biosimilar market is expected to grow at a CAGR of 15%, reaching a market size of $75 billion by 2030[24]. - The global heparin active pharmaceutical ingredient market is projected to reach $6.199 billion by 2027, with a CAGR of 17.19%[24]. - The global oncology drug expenditure is projected to grow from $196 billion in 2022 to $375 billion by 2027[26]. - The number of new cancer cases globally increased from 18.079 million in 2018 to 19.965 million in 2022, with an expected growth of 77% by 2050[26]. - The Chinese oncology drug market is expected to reach ¥662 billion by 2030, doubling from 2023, with a CAGR of 10.2%[27]. - The global CDMO market size is projected to reach $124.3 billion by 2025, while the Chinese CDMO market is expected to reach ¥157.1 billion[28]. Company Strategy and Development - The company is positioned in the pharmaceutical manufacturing industry, which is expected to maintain a strong growth trend due to rising drug demand[22]. - The company is focusing on the development of biosimilars, with significant market potential as many blockbuster biologics lose exclusivity[23]. - The company aims to build a world-class biopharmaceutical enterprise, with a strategic focus on both the US and global markets[30]. - The company has established a complete industrial chain capability from drug research and development to large-scale production and commercialization[30]. - The company is actively involved in the development of innovative drugs, supported by recent government policies aimed at enhancing the pharmaceutical industry[29]. - The company is focusing on the transition from generic to innovative pharmaceuticals, enhancing its independent innovation capabilities[38]. - The company is expanding its product offerings and market presence through strategic initiatives and partnerships[30]. - The company is expanding its business in Europe and other global markets, leveraging its production and quality advantages, particularly with the increasing registration of enoxaparin products in more countries[35]. Research and Development - The company has over 500 R&D personnel, including more than 100 with master's or doctoral degrees, and has established three major collaborative R&D centers in Nanjing, Chengdu, and North America to enhance R&D efficiency and reduce costs[47]. - The company ranks first among domestic peers in the number of ANDA approvals, with increasing R&D investment and efficiency, allowing for timely market entry of generic drugs before original patents expire[51]. - The company is actively exploring the nucleic acid drug field and expanding its R&D strategy into oncology, immunoregulation, and other key disease areas[49]. - The company's R&D investment reached CNY 190.92 million, accounting for 8.91% of revenue, an increase of 16.76% compared to the same period last year[57]. Financial Position and Liabilities - Total assets at the end of the reporting period were ¥9,785,834,137.93, reflecting a 2.75% increase from ¥9,524,263,988.46 at the end of the previous year[18]. - The total liabilities decreased to CNY 2,094,467,958.26 from CNY 2,967,134,031.32, indicating a reduction in financial obligations[152]. - The company's debt-to-asset ratio remains reasonable, indicating good credit status[144]. - The total guarantee amount for the reporting period (excluding guarantees for subsidiaries) is CNY 1,430,344,000[120]. - The total guarantee balance at the end of the reporting period (excluding guarantees for subsidiaries) is CNY 656,468,000, which accounts for 10.82% of the company's net assets[120]. Environmental Compliance - The company has not faced any significant legal penalties for environmental violations during the reporting period[91]. - The company’s wastewater treatment meets the standards set by the relevant environmental regulations[95]. - The company has implemented a comprehensive environmental monitoring plan, with third-party testing conducted for wastewater, waste gas, and noise, all meeting regulatory standards[100]. - The company has achieved ISO9001, ISO14001, and ISO45001 certifications, demonstrating its commitment to environmental management and quality control[102]. Shareholder and Corporate Governance - The company reported a commitment to not transfer or manage shares held by major shareholders for 36 months post-IPO, with a limit of 25% transfer per year during their tenure[105]. - Major shareholders committed to not interfere with company management and to fulfill measures to compensate for any dilution of immediate returns[105]. - The company has established a commitment to avoid any competitive business activities that may conflict with its current operations[107]. - The company maintains a strong compliance record, with no violations or penalties reported against its executives or major shareholders[116]. Future Outlook - The company has provided a performance guidance for the second half of 2024, expecting a revenue growth of 10% to 12%[113]. - New product launches are anticipated to contribute an additional 5% to overall revenue in the upcoming quarters[113]. - The company is investing in R&D, with a budget increase of 25% for new technology development aimed at enhancing product efficacy[113].

| 证券代码：603707 | 证券简称：健友股份 公告编号：2024-063 | | --- | --- | | 债券代码：113579 | 债券简称：健友转债 | 南京健友生化制药股份有限公司 关于完成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、准确性和完整性承担个别及连带责任。 1、统一社会信用代码：91320100726054999R 2、名称：南京健友生化制药股份有限公司 3、类型：股份有限公司（上市、自然人投资或控股） 4、住所：南京高新开发区 MA010-1 号地 5、法定代表人：TANG YONGQUN(唐咏群) 6、注册资本：161,664.8684 万元整 7、成立日期：2000 年 10 月 16 日 8、营业期限：2000 年 10 月 16 日至****** 9、经营范围：许可项目：药品批发；药品生产；药品零售（依法须经批准的项 目，经相关部门批准后方可开展经营活动，具体经营项目以审批结果为准） 一般项目：采购代理服务；技术进出口；住房租赁；技术服务、技术开发、 技术咨询、技术交流、技术转让、技术推广；医学 ...

| 证券代码：603707 | 证券简称：健友股份 公告编号：2024-062 | | --- | --- | | 债券代码：113579 | 债券简称：健友转债 | （一）药品名称：盐酸罗哌卡因注射液 （二）适 应 症：盐酸罗哌卡因注射液适用于外科手术麻醉和急性疼痛控制 （三）剂 型：注射剂 南京健友生化制药股份有限公司 关于子公司产品盐酸罗哌卡因注射液 获得美国 FDA 批准的公告 本公司董事会、全体董事及相关股东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、准确性和完整性承担个别及连 带责任。 南京健友生化制药股份有限公司（以下简称"健友股份"或"公司"）子公司健 进制药有限公司（以下简称"健进制药"）于近日收到美国食品药品监督管理局（以 下简称"美国 FDA"）签发的盐酸罗哌卡因注射液，USP，20 mg/10 mL (2 mg/mL), 40 mg/20 mL (2 mg/mL), 100 mg/20 mL (5 mg/mL), 150 mg/30 mL (5 mg/mL), 100 mg/10 mL (10 mg/mL), 200 mg/20 mL (10 mg/ ...

Summary of Conference Call Transcript Company and Industry Involved - The company mentioned is involved in the pharmaceutical industry, specifically in the context of product approval and market entry in the United States. Core Points and Arguments - The company successfully filed for approval in the United States in 2013, indicating a significant milestone in its product development timeline [1] - The company claims to be the fastest in the market among its peers, having achieved product launch in the U.S. within a 19-year timeframe [1] - The company highlights that its investment and efforts towards product development began as early as 2010, showcasing a long-term commitment to innovation and market readiness [1] Other Important but Possibly Overlooked Content - The reference to being the "slowest" in the context of the timeline suggests a competitive landscape where speed to market is critical, emphasizing the importance of regulatory processes and strategic planning [1]

Financial Data and Key Metrics Changes - The company has seen a significant increase in R&D expenses, reaching 360 million yuan, with two-thirds of this amount allocated to biopharmaceuticals, indicating a strong focus on this area [2][4] - The company anticipates a net profit margin of approximately 15% to 20% for 2024 compared to 2023, reflecting a positive outlook on profitability despite market challenges [28] Business Line Data and Key Metrics Changes - The company aims to expand its product offerings from over 50 to 120 by 2027, focusing on small molecule drugs, which have been a significant contributor to gross profit [1][4] - The company is actively developing three insulin products, with expectations for clinical trials to progress as planned, indicating a robust pipeline in the diabetes treatment segment [11] Market Data and Key Metrics Changes - The company predicts a gradual recovery in raw material prices, with expectations of a 10% increase by early next year, following a period of price stabilization [14][22] - The biopharmaceutical market is expected to see significant growth, with the company projecting that biosimilars could capture 70% to 80% of the market by 2030 [33] Company Strategy and Development Direction - The company is positioning itself as a key player in the U.S. biopharmaceutical market, emphasizing rapid product development and high-quality standards [1][4] - The strategy includes a focus on collaboration in R&D, particularly in the biopharmaceutical sector, to enhance innovation and market competitiveness [2][4] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the approval timelines for key products, including a biosimilar expected to be approved in Q4 of this year, which could generate significant revenue [8][9] - The management highlighted the importance of maintaining price stability in a competitive market, indicating a preference for sustainable profit margins over aggressive pricing strategies [49][54] Other Important Information - The company has successfully resolved patent challenges for key products, which is expected to facilitate smoother market entry and sales [7][8] - The management noted that the global market for biopharmaceuticals is becoming increasingly competitive, with a focus on quality and compliance as critical success factors [4][5] Q&A Session Summary Question: What is the market outlook for the biosimilar Adalimumab? - The company anticipates that biosimilars will significantly increase their market share, potentially reaching 70% to 80% by 2030, driven by the expiration of patents and increased competition [33][35] Question: How does the company plan to manage its inventory levels? - Management clarified that while inventory levels are currently high, they are not overly concerning, as they are in line with industry standards and will be managed strategically to avoid price wars [42][44] Question: What is the company's strategy regarding pricing in a competitive environment? - The company aims to maintain price stability and avoid aggressive price competition, focusing instead on quality and sustainable profit margins [49][54]

南京健友生化制药股份有限公司（以下简称"健友股份"或"公司"）子公 司健进制药有限公司（以下简称"健进制药"）于近日收到国家药品监督管理局 （以下简称"国家药监局"）关于核准签发注射用阿扎胞苷（规格：100mg）药 品注册证书的通知（药品批准文号：国药准字 H20244451），现将相关情况公告 如下： | 证券代码：603707 | 证券简称：健友股份 公告编号：2024-061 | | --- | --- | | 债券代码：113579 | 债券简称：健友转债 | 南京健友生化制药股份有限公司 关于子公司产品注射用阿扎胞苷 获得国家药品监督管理局药品注册证书的公告 本公司董事会、全体董事及相关股东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、准确性和完整性承担个别及连 带责任。 一、药品的基本情况 1、 药品名称：注射用阿扎胞苷 规格：100mg（按 C8H12N4O5 计） 剂型：注射剂（冻干粉针剂） 申请事项：仿制药申请 注册分类：化学药品 4 类 申报阶段：生产 上市许可持有人：健进制药有限公司 受理号：CYHS2201599 药品批准文号：国药准字 H202444 ...

Summary of the Conference Call for Jianyou Co., Ltd. Company Overview - **Company**: Jianyou Co., Ltd. - **Industry**: Pharmaceutical and Biopharmaceuticals Key Points and Arguments 1. **Market Conditions**: The current pharmaceutical market is experiencing a downturn, but Jianyou Co., Ltd. believes the worst is over and is focusing on strategic execution capabilities [2][3] 2. **Transition to Formulations**: The company has successfully transitioned from raw materials to formulation exports, with 75% of its business now related to formulations, primarily for export to the U.S. [8][9] 3. **Market Share**: Jianyou holds approximately 20% market share in the U.S. for its products, with a significant portion of its revenue coming from non-Gansu products [9][10] 4. **Biologics Development**: The company has invested 5 to 6 years in biologics research and has recently gained market access for its adalimumab product in the U.S. [10][11] 5. **Future Growth Plans**: From 2024 to 2030, Jianyou aims to increase its commercialized products from over 50 to 120, focusing on biosimilars [11][12] 6. **Quality Control and Regulatory Compliance**: The company emphasizes the importance of maintaining high-quality standards and compliance with FDA regulations, especially in light of recent scrutiny of other companies [18][19] 7. **Market Dynamics**: The company anticipates an increase in regulatory scrutiny and inspections as more Chinese companies enter the U.S. market, which may lead to more frequent audits [20][21] 8. **Raw Material Pricing**: The raw material market has seen a decline, impacting profit margins, but Jianyou expects to stabilize and improve its financial performance in the coming years [44][45] 9. **Profit Margins**: The company projects that its gross margins will remain stable, with expectations of slight improvements as market conditions recover [50][53] 10. **Product Pipeline**: Jianyou is focused on launching several biologics, including insulin and growth hormone products, with expected commercialization timelines within the next 1 to 2 years [58][59] Additional Important Information - **Strategic Focus**: The company is committed to enhancing its competitive edge through continuous improvement in operational capabilities and resource allocation [13][14] - **Market Trends**: There is a growing demand for high-quality biologics and sterile injectables, which Jianyou aims to capitalize on [32][33] - **Global Expansion**: Jianyou is exploring opportunities in non-regulated markets while maintaining a primary focus on regulated markets [35][36] - **Investor Engagement**: The company encourages investor questions and discussions to foster transparency and engagement [14][15] This summary encapsulates the key insights and strategic directions discussed during the conference call for Jianyou Co., Ltd., highlighting its market position, growth strategies, and operational focus.