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"）于近 日收到国家药品监督管理局（以下简称"NMPA"）签发的氟维司群注射液 5ml： 0.25g 的药品注册证书（药品批准文号为国药准字 H20253243），现将相关情况 公告如下： 关于获得国家药品监督管理局 氟维司群注射液药品注册批件的公告 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。 | 证券代码：603707 | 证券简称：健友股份 | 公告编号：2025-005 | | --- | --- | --- | | 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 一、药品的基本情况 （六）申 请 人：南京健友生化制药股份有限公司 二、药品其他相关情况 （一）药品名称：氟维司群注射液 （二）适 应 症： 本品可用于在抗雌激素辅助治疗后或治疗过程中复发的，或是在抗雌激素治 疗中进展的绝经后(包括自然绝经和人工绝经)雌激素受体阳性的局部晚期或转 移性乳腺癌。 本品与阿贝西利联合治疗适用于激素受体（HR）阳性、人表皮生长因 ...

Investment Rating - The investment rating for the company is maintained as "Buy" with a target price of RMB 20.34 [6][7]. Core Insights - The company is expected to turn a profit in 2024, projecting a net profit attributable to shareholders of RMB 8.0-10.5 billion, with a non-recurring net profit of RMB 7.5-10.0 billion. The reversal of inventory impairment provisions is expected to increase net profit by RMB 1.36-2.04 billion [1]. - The company's formulation business remains the main growth driver, with strong performance in the U.S. market, where approximately 90 products have been approved, and 7 new products are expected to be approved in 2024. The domestic market is also stabilizing with 8 new product approvals expected in 2024 [2]. - The biosimilar drug segment is anticipated to become a significant growth engine, with the launch of adalimumab biosimilar and other products like liraglutide and paclitaxel expected to be approved in 1H25 [3]. Summary by Sections Financial Performance - The company forecasts net profits of RMB 9.92 billion, RMB 12.31 billion, and RMB 16.14 billion for 2024-2026, with a 16.8% upward adjustment for 2024 due to inventory impairment reversal. The EPS for 2024-2026 is projected at RMB 0.61, RMB 0.76, and RMB 1.00 respectively [4][10]. Valuation - The company is assigned a PE ratio of 26.70x for 2025, reflecting a 20% premium over comparable companies, leading to a reasonable valuation of RMB 328.60 billion [4][11]. Market Data - As of January 24, the closing price was RMB 13.48, with a market capitalization of RMB 21.779 billion. The 52-week price range was RMB 10.70-15.61 [7][10].

| 证券代码：603707 | 证券简称：健友股份 | 公告编号：2025-004 | | --- | --- | --- | | 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 关于产品亚甲蓝注射液 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"）于近日收 到美国食品药品监督管理局（以下简称"美国 FDA"）签发的亚甲蓝注射液，50 mg/10 mL (5 mg/mL),（ANDA 号：217380）批准信，现将相关情况公告如下： 一、药品的基本情况 二、药品其他相关情况 公司于近日获得美国 FDA 的通知，公司向美国 FDA 申报的亚甲蓝注射液， 50 mg/10 mL (5 mg/mL)的 ANDA 申请获得批准。 亚甲蓝注射液原研药品，由 PROVEPHARM SAS 持有，2016 年 04 月 08 日 前经 FDA 批准在美国上市。商品名为 PROVAYBULE，规格为 50 mg/10 mL (5 mg/m ...

| 证券代码：603707 | 证券简称：健友股份 公告编号：2025-003 | | --- | --- | | 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 2024 年度拟转回存货跌价准备的提示性公告 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： 南京健友生化制药股份有限公司（以下简称"公司"）根据《企业会计准则 第 1 号——存货》及公司会计政策等相关规定，对截至 2024 年 12 月 31 日存货 进行了初步减值测试，公司 2024 年度拟转回存货跌价准备 16,000.00 万元到 24,000.00 万元，预计导致归属于上市公司股东的净利润增加 13,600.00 万元到 20,400.00 万元。 本次拟转回存货跌价准备金额未经审计，最终会计处理及对公司 2024 年度 利润的影响以公司披露的 2024 年度报告为准。具体情况如下： 一、本次拟转回存货跌价准备概况 (一）公司存货储备的说明 2022 年-2024 年各年末，公司存货账面余额分别为 5 ...

Financial Performance Forecast - The company expects a net profit attributable to shareholders of between 800 million and 1.05 billion yuan for the year 2024, indicating a turnaround from a loss in the previous year[4]. - The estimated net profit after deducting non-recurring gains and losses for 2024 is projected to be between 750 million and 1 billion yuan[4]. - The company plans to reverse inventory impairment provisions between 160 million and 240 million yuan in 2024, which is expected to increase net profit by approximately 136 million to 204 million yuan[8]. - The performance forecast is based on preliminary calculations and has not yet been audited by a registered accounting firm[9]. - The company emphasizes that the forecast data is subject to change and the final figures will be disclosed in the official 2024 annual report[10]. - There are currently no major uncertainties affecting the accuracy of the performance forecast[9]. Previous Financial Performance - In 2023, the company reported a net loss attributable to shareholders of approximately 189.45 million yuan[7]. - The company faced a significant inventory impairment of 1.24 billion yuan in 2023 due to downstream customer destocking in the heparin industry[8]. Raw Material Costs - The average procurement price of raw materials in 2024 is expected to decrease significantly compared to the previous year, leading to lower inventory costs[8]. Communication and Discrepancies - The company has communicated with its accounting firm regarding the performance forecast, and there are no significant discrepancies[4].

| 证券代码：603707 | 证券简称：健友股份 公告编号：2025-001 | | --- | --- | | 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"健友转债"转股结果暨股份变动的公告 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： 转股情况： 截至 2024 年 12 月 31 日，累计已有人民币 719,000 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 18,035 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 12 月 31 日，尚未转股的"健友转债"金额为人民币 502,464,000 元，占"健友转债"发行总量的比例为 99.86%。 一、可转债的发行上市概况 二、可转债本次转股情况 自 2024 年 10 月 1 日至 2024 年 12 月 31 日期间，有人民币 11,000 元"健友 转债"转为公司普通股。自 2024 年 10 月 1 ...

Investment Rating - The report assigns a "Buy" rating for the company, indicating a positive outlook for its stock performance [2][114]. Core Insights - The company is positioned as an international injection platform, focusing on biosimilars, which are expected to yield significant performance improvements as approvals are granted [7][114]. - The company has a strong presence in the heparin raw material and formulation markets, with a stable growth trajectory anticipated for its domestic formulation business [8][30]. - The company has significantly increased its R&D investment, with a notable rise in the number of ANDA approvals in the U.S. market, indicating a robust pipeline for future growth [9][71]. Summary by Sections Company Overview - The company has evolved from a traditional raw material supplier to a leading international sterile injection provider, with operations in over 60 countries [18][21]. - It has established three major R&D centers globally, enhancing its innovation capabilities [80]. Heparin API Market - The heparin API market is expected to grow steadily, with price stabilization anticipated following a period of inventory destocking [46][49]. - The company ranks among the top three domestic suppliers of heparin raw materials, benefiting from a stable competitive landscape [49]. R&D and Product Pipeline - R&D expenditures have surged, with a 89.42% year-on-year increase in 2023, reflecting the company's commitment to innovation [71][73]. - The company has a diverse pipeline with 59 projects underway, covering various therapeutic areas, and has successfully obtained approvals for 13 new formulations in 2023 [81][87]. Financial Projections - The company forecasts significant growth in net profit from 8.59 billion to 16.79 billion yuan from 2024 to 2026, with corresponding PE ratios decreasing from 26.6 to 13.6 [7][114]. - Revenue from the formulation segment is expected to grow at a compound annual growth rate (CAGR) of 24% to 30% over the same period, driven by new product launches and market expansion [108][114]. Market Position and Competitive Advantage - The company has successfully integrated its operations through strategic acquisitions, such as Meitheal, enhancing its market access in the U.S. [89]. - It has a strong market share in key heparin products, with the company’s formulations contributing significantly to its revenue [62][64].

Investment Rating - The report assigns an "Accumulate" rating for the company [4]. Core Views - The company reported a revenue of 3.088 billion yuan for the first three quarters of 2024, a year-on-year decrease of 1.72%, with a net profit attributable to shareholders of 606 million yuan, down 27.82% year-on-year [4]. - The company is transitioning from a focus on raw materials to high-end formulations, successfully establishing a presence in the international sterile formulations market [4]. - The company has built a complete sales channel and operational experience in the North American market, positioning itself to capitalize on opportunities in the biosimilar drug market [4]. - Earnings per share (EPS) forecasts for 2024-2026 are 0.51, 0.69, and 0.91 yuan, with corresponding price-to-earnings (PE) ratios of 28.62, 21.23, and 16.16 [4]. Financial Performance Summary - For the first three quarters of 2024, the gross margin was 41.41%, down 7.99 percentage points year-on-year, and the net profit margin was 19.62%, down 7.10 percentage points year-on-year [4]. - The company’s revenue for the third quarter alone was 945 million yuan, reflecting a year-on-year increase of 12.79% [4]. - The company’s revenue projections for 2024-2026 are 4.218 billion, 5.230 billion, and 6.602 billion yuan, with year-on-year growth rates of 7.3%, 24.0%, and 26.2% respectively [5]. Market Position and Strategy - The company has successfully reduced the proportion of revenue from heparin raw materials from over 60% in 2019 to 20% in the first half of 2024, indicating a strategic shift towards high-end formulations [4]. - The company has acquired the rights to the FDA approval and related patents for a biosimilar drug, making it the first Chinese company to gain entry into the U.S. market for this specific biosimilar [4].

| 证券代码：603707 | 证券简称：健友股份 | 公告编号：2024-080 | | --- | --- | --- | | 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 关于维生素 B12 注射液获得 美国 FDA 药品注册批件的公告 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。 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"）于近日收 到美国食品药品监督管理局（以下简称"美国 FDA"）签发的维生素 B12 注射液， 1,000 mcg/mL, 10,000 mcg/10 mL (1,000 mcg/mL), 30,000 mcg/30 mL (1,000 mcg/mL)（ANDA 号：214316）批准信，现将相关情况公告如下： 二、药品其他相关情况 公司于近日获得美国 FDA 的通知，公司向美国 FDA 申报的维生素 B12 注 射液，1,000 mcg/mL, 10,000 mcg/10 mL (1,000 mcg/mL), 30,000 mcg/3 ...

Investment Rating - The investment rating for the company is "Accumulate" (maintained) [3] Core Views - The company is experiencing a recovery in its performance, with a notable increase in revenue in the third quarter, achieving a year-on-year growth of 12.79% [4] - The company is entering a new growth cycle driven by high-end biological agents and complex formulations, with several products expected to contribute to revenue in the near future [5] - The financial forecasts for the company indicate a gradual improvement in earnings per share (EPS) from -0.12 yuan in 2024 to 0.91 yuan in 2026, with corresponding price-to-earnings (P/E) ratios decreasing from 27.64 to 16.34 over the same period [6] Summary by Sections Financial Performance - In the first three quarters of 2024, the company reported revenue of 3.088 billion yuan, a year-on-year decrease of 1.72%, and a net profit attributable to shareholders of 606 million yuan, down 27.82% year-on-year [3] - The third quarter alone saw revenue of 945 million yuan, marking a 12.79% increase year-on-year, while net profit for the quarter was 201 million yuan, a decline of 6.54% year-on-year [3][4] Growth Drivers - The company is strategically focusing on high-end complex formulations and biosimilar products, with the introduction of adalimumab biosimilar contributing to revenue and several products expected to receive FDA approval [5] - The domestic formulation business is expected to stabilize as the impact of centralized procurement diminishes, and the heparin raw material business risks have been alleviated [5] Financial Projections - The company forecasts revenues of 3.931 billion yuan in 2024, with a year-on-year growth of 8.0%, and net profit expected to rebound to 874 million yuan, reflecting a significant recovery from previous losses [9] - The gross margin is projected to be 42.2% in 2024, with a gradual increase to 46.4% by 2026 [9]