证券研究报告 健友股份 (603707 CH) 整装待发，生物类似药启新程 2024年10月11日│中国内地 华泰研究 深度研究 投资评级(维持): 买入 目标价(人民币): 21.09 生物类似药带来创新转型节点，传统业务筑底向上 我们认为公司处于从一体化仿制药向创新驱动转型的节点，生物类似药引擎 启动在即，白蛋白紫杉醇有望在 25 年放量，加之阿达木单抗、胰岛素等陆 续上市形成梯队，打开成长天花板。传统业务呈向上反转趋势：1）制剂集 采压力渐出清，原料药量价见修复；2）非肝素制剂美国批件数量快速增长， 有望成为未来 2-3 年增长支撑。我们看好公司制剂高增长和生物药布局，预 计2024-26E年归母净利润8.63/12.56/16.82亿元，对应EPS 0.53/0.78/1.04 元；给予公司 2025 年 27.12x PE（较可比公司溢价 20%，主因公司原料药 承压业务收入占比较小），对应目标价为 21.09 元，维持"买入"。 非肝素制剂：扩展成熟业务版图，为公司未来 2-3 年的增长添动能 从核心产品依诺肝素制剂出发，公司已经培育出了成熟的制剂出口业务， 2023 年实现收入超 19 亿元，同 ...

关于"健友转债"转股结果暨股份变动的公告 | 证券代码：603707 | 证券简称：健友股份 公告编号：2024-070 | | --- | --- | | 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 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： 转股情况： 截至 2024 年 9 月 30 日，累计已有人民币 708,000 元"健友转债"转为公司 普通股，累计回售人民币 7,000 元"健友转债"。"健友转债"累计转股股数 17,586 股，占转股前公司股份总额的 0.001%。 未转股可转债情况： 截至 2024 年 9 月 30 日，尚未转股的"健友转债"金额为人民币 502,475,000 元，占"健友转债"发行总量的比例为 99.86%。 经中国证券监督管理委员会《关于核准南京健友生化制药股份有限公司公开 发行可转换公司债券的批复》（证监许可[2020]603 号）核准，南京健友生化制 药股份有限公司（以下简称"公司"）公开发行了 5,031,900 张 ...

Investment Rating - The report initiates coverage on the company with a "Buy" rating, setting a target price of 18.15 RMB for 2025, based on a 25x PE ratio [5][7] Core Views - The company has successfully transitioned from being primarily an API producer to a formulation-focused business, with overseas formulations expected to drive high growth [1] - As the global leader in heparin API, the company is expected to maintain stable revenue in this segment as heparin prices stabilize [2] - The company's international capabilities in injectable formulations are leading in China, with 69 ANDA approvals as of July 2024, the highest among domestic companies [3] - The company is diversifying into biosimilars, with four biosimilar candidates in Phase I clinical trials and strategic partnerships in insulin development [4] Financial Projections - Revenue is projected to grow from 4.33 billion RMB in 2024 to 6.49 billion RMB in 2026, with a CAGR of 21.1% [5] - Net profit attributable to shareholders is expected to increase from 802.85 million RMB in 2024 to 1.52 billion RMB in 2026 [5] - The company's EPS is forecasted to grow from 0.50 RMB in 2024 to 0.94 RMB in 2026 [6] Heparin Business - The company is the global leader in heparin API, with exports stabilizing around $5,000/kg in H1 2024 after a price decline from pandemic highs [2] - Heparin API revenue has been declining since 2020 due to inventory destocking and formulation business focus, but is expected to stabilize [35] - The company has passed multiple international quality certifications, including FDA, EDQM, and PMDA [36] Formulation Business - The company has 69 ANDA approvals for injectables as of July 2024, leading among Chinese companies [3] - Domestic formulation business has been impacted by volume-based procurement, but the company maintains leading market shares in several low molecular weight heparin products [43] - The company has been successful in national centralized procurement, winning bids for several key products [48] International Expansion - Through its subsidiary Meitheal, the company has established a strong presence in the US injectable market, leveraging GPO and IDN/PN channels [54] - The company has made strategic acquisitions and partnerships to expand its product portfolio, including albumin-bound paclitaxel and adalimumab biosimilar [4][64] - Meitheal's local expertise in the US market has significantly enhanced the company's R&D and regulatory capabilities [61] Biosimilar Business - The company has four biosimilar candidates in Phase I clinical trials and has entered into partnerships for insulin development [4] - The company acquired the US commercialization rights for adalimumab biosimilar Yusimry for $40 million in June 2024 [4] - The biosimilar market is expected to grow rapidly, with global sales projected to reach $164.4 billion by 2030 [72] Quality and Regulatory - The company has a strong track record of passing FDA inspections, with multiple facilities and products receiving approvals [59] - The company's high-quality standards and advanced manufacturing technologies have established it as a leader in sterile injectables [59]

| 股票代码：603707 | 股票简称：健友股份 | 公告编号：2024-069 | | --- | --- | --- | | 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 关于公司向银行申请综合授信额度 及提供抵押担保的进展公告 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。 一、向银行申请授信审议情况 种类：出口卖方信贷 二、关于向银行申请授信进展及提供资产抵押的情况 公司近日与进出口银行签署了金额为 30,000 万元的《借款合同》,公司以其 房地产作抵押物为其向进出口银行融资提供抵押担保，具体如下： 1、抵押合同签订情况 公司与进出口银行按坐落地址分别签署了《房地产抵押合同》。 公司本次抵押资产明细如下： | 序号 | 证书字号 | | | | 坐 落 | | | 建筑面积 （㎡） | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1 | 宁房权证浦变字第 | 331297 | 号 | | 浦口区高 ...

| 证券代码：603707 | 证券简称：健友股份 | 公告编号：2024-068 | | --- | --- | --- | | 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 关于子公司产品氟尿嘧啶注射液 获得美国 FDA 批准的公告 （一）药品名称：氟尿嘧啶注射液 （二）适 应 症：适用于乳腺及消化系统（结肠、直肠、胃、胰腺）腺癌的 治疗 （三）剂 型：注射剂 （四）规 格：2.5 g/50 mL (50 mg/mL) （五）ANDA 号：216494 （六）申 请 人：健进制药有限公司 二、药品其他相关情况 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。 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"）签发的氟尿嘧啶注射液，2.5 g/50 mL (50 mg/mL) 药房 大包装的 ANDA 批准通知（ANDA 号：216494）。现将相关情况公告如下 ...

Investment Rating - The report maintains a "Buy" rating for the company [8] Core Views - The company is undergoing a transformation and entering a new phase of internationalization in high-end formulations [3] - The company achieved a revenue of 2.14 billion yuan in the first half of 2024, a year-on-year decrease of 6.99%, with a net profit of 405 million yuan, down 35.15% [3] - The second quarter of 2024 showed signs of recovery with a revenue of 1.14 billion yuan, a year-on-year increase of 14.3% [4] - The overseas formulation segment continues to grow rapidly, accounting for 53.60% of total revenue in the first half of 2024 [5] - The company is focusing on developing a pipeline of biosimilars and high-end complex formulations, which are expected to drive new growth [6] Financial Summary - The company forecasts EPS of 0.54 yuan, 0.70 yuan, and 0.91 yuan for 2024, 2025, and 2026 respectively, with corresponding PE ratios of 24.27, 18.76, and 14.40 [7][8] - Revenue projections for 2024, 2025, and 2026 are 4.245 billion yuan, 5.096 billion yuan, and 6.310 billion yuan, representing year-on-year growth rates of 8.0%, 20.1%, and 23.8% respectively [8] - The net profit is expected to recover significantly in 2024 with a forecast of 875 million yuan, a year-on-year increase of 561.7% [8]

| 证券代码：603707 | 证券简称：健友股份 | 公告编号：2024-067 | | --- | --- | --- | | 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 关于子公司产品奥沙利铂注射液 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。 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"）关于核准签发奥沙利铂注射液（规格：10ml：50mg 和 20ml：100mg）药品注册证书的通知（药品批准文号：国药准字 H20244822 和 国药准字 H20244821），现将相关情况公告如下： 一、药品的基本情况 药品批准文号：国药准字 H20244822、国药准字 H20244821 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品 符合药品注册的有关要求，批准注册，发给药品注册证书。 ...

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 | --- | --- | --- | --- | |-------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|------------------------------| | ...

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].