Investment Rating - The report gives a "Buy" rating for the company [5]. Core Views - The company is transitioning towards high-end formulations, with a significant increase in the proportion of formulation business, which accounted for over 70% of total revenue in 2023. This shift reflects a successful transformation from a traditional raw material supplier to an international sterile injection enterprise [1][17]. - The company has established a strong presence in the U.S. market, with over 50 products operational and a leading position in ANDA approvals among domestic peers. The U.S. subsidiary generated sales of 1.63 billion yuan in 2023, marking it as one of the largest Chinese pharmaceutical companies engaged in high-end formulation sales in the U.S. [2][19]. - The report forecasts revenue growth driven by overseas formulation business, with projected revenues of 4.24 billion yuan, 5.57 billion yuan, and 7.19 billion yuan for 2024, 2025, and 2026, respectively [4][19]. Summary by Sections Company Overview - The company is one of the largest global suppliers of heparin raw materials and formulations, with over 80 formulation varieties in more than 60 countries. It has been increasing R&D investments to support its transition to high-end formulations [1][10]. Formulation Business - The formulation business is the main source of revenue and profit for the company, with sales increasing from 762 million yuan in 2019 to 2.77 billion yuan in 2023, representing 70.50% of total revenue. The gross profit from this segment also rose significantly during the same period [22][23]. - The company has been actively participating in national procurement, which has helped maintain growth in domestic formulation sales despite some price pressures [24][40]. Heparin Raw Materials - The heparin raw material business has seen a mild recovery, with stable production levels. However, the company faced a significant inventory impairment charge of 1.24 billion yuan in 2023 due to declining prices, which impacted net profit [3][19]. - The report anticipates a recovery in the global heparin market in 2024, with a potential reversal of inventory impairment provisions, which could positively affect net profit [3][19]. Financial Forecast and Investment Recommendations - The company is expected to achieve a turnaround in profitability, with projected net profits of 946 million yuan, 1.16 billion yuan, and 1.62 billion yuan for 2024, 2025, and 2026, respectively. The earnings per share (EPS) are forecasted to be 0.59 yuan, 0.72 yuan, and 1.00 yuan for the same years [4][19]. - The report emphasizes the company's commitment to high-margin formulation business and its ongoing expansion into international markets, which are expected to drive future growth [17][19].

公 华福证券 生物类似药出海天地广阔，自研+BD 模式进一步打开成长天花板 随着全球多个重磅生物药专利陆续到期，全球生物类似药市场规 模有望快速增长。自研方面，截至 23 年公司多肽类制剂有 4 个产品 美国审批中、1 个产品注册批生产完成、6 个产品前期研发中。BD 方 面，公司 2024 年购买阿达木单抗类似药取得美国生物类似药市场入场 券， 近年来公司积极寻求外部合作，先后与海南双成、通化东宝达成 战略合作，取得白蛋白紫杉醇、甘精、门冬、赖脯三种胰岛素在美国 市场的独家商业化权益，未来随着生物类似药在美国市场获批，有望 助力海外制剂业务快速放量。 华福证券 投资要点： 肝素原料药市场边际改善，公司 API 业务有望稳健增长 公 司 首 次 覆 盖 2023 受到下游企业去库存影响，肝素原料药需求端减弱，价格进 入下跌周期，公司于 23 年对 API 存货计提 12.4 亿元跌价准备，当前 随着供给端格局稳定+需求端去库存周期或接近尾声，肝素价格有望恢 复。公司作为肝素原料药龙头，相关业务收入体量及毛利率未来有望 回升。2024 年公司拟转回存货跌价准备 1.6-2.4 亿元，我们认为若未来 肝素行业景气 ...

Investment Rating - The report initiates coverage with a "Buy" rating for the company [5][7]. Core Views - The heparin raw material market is showing marginal improvement, and the company's API business is expected to grow steadily [3][29]. - The company is focusing on sterile injection formulations, with rapid growth in overseas formulation business [4][41]. - The global biosimilar drug market is anticipated to grow significantly, with the company leveraging both self-research and business development (BD) models to expand its growth potential [5][67]. Summary by Sections 1. Company Overview - The company is a leading supplier of heparin raw materials and has been transitioning towards high-end injection formulations and biosimilars, aiming to reduce its reliance on traditional raw material labels [13][16]. 2. Heparin Raw Material Market - The heparin raw material market is expected to recover as supply-side stability and the end of inventory destocking on the demand side are anticipated [3][31]. - The company has established stable supply relationships with major global heparin formulation manufacturers, providing a solid cash flow for its injection business [36][37]. 3. Focus on Sterile Injection Formulations - The company's injection business has shown robust growth, with a revenue increase of 12.8% in 2023 and a compound annual growth rate (CAGR) of 47.4% from 2018 to 2023 [41][46]. - The company has a diverse product matrix in sterile injections, including low molecular weight heparin and anti-tumor agents, with a significant portion of revenue coming from overseas markets [47][55]. 4. Biosimilar Drug Development - The global biosimilar market is projected to grow rapidly, with the company actively pursuing opportunities in this space, including acquiring rights to a biosimilar of adalimumab [5][72]. - The company has multiple biosimilar products in various stages of development, enhancing its growth prospects in international markets [67][72]. 5. Financial Projections - The company is expected to achieve net profits of 0.9 billion, 1.2 billion, and 1.5 billion yuan for the years 2024, 2025, and 2026, respectively, with significant growth rates projected [5][6].

| 证券代码：603707 | 证券简称：健友股份 | 公告编号：2025-008 | | --- | --- | --- | | 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 关于子公司与 Xentria 签署 许可协议暨关联交易的进展公告 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、本次交易概述 根据协议的约定，在完成 XTMAB 多剂量爬坡试验（MAD）或临床 2 期研究入 组时，支付 2,000 万美元。目前 XTMAB 项目临床 2 期受试者已经筛选完毕，经过 联合指导委员会批准，公司子公司于 2025 年 3 月 5 日向 Xentria 支付 500 万美 元进度款。截至本公告披露日，就 XTMAB 项目公司子公司已累计支付 1,000 万美 元。 三、XTMAB 项目进展情况 XTMAB 是一种肿瘤坏死因子 α（TNFα）抑制剂，旨在稳定免疫失调。TNFα 是炎症的关键调节因子，对肉芽肿的形成至关重要，通常导致疾病进展。目前已 经证明 XTMAB-16 对肺 ...

南京健友生化制药股份有限公司 关于获得国家药品监督管理局 罗库溴铵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。 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"）签发的罗库溴铵注射液 5ml： 50mg 及 10ml：100mg 的药品注册证书（药品批准文号分别为：国药准字 H20253446、国药准字 H20253447），现将相关情况公告如下： 一、药品的基本情况 （一）药品名称：罗库溴铵注射液 （二）适 应 症： | 证券代码：603707 | 证券简称：健友股份 | 公告编号：2025-007 | | --- | --- | --- | | 债券代码：113579 | 债券简称：健友转债 | | 公司于 2025 年 02 月 28 日获得 NMPA 通知，公司注册申报的罗库溴铵注射 液（5ml：50mg、10ml：100mg）的化学药品 4 类上市许可申请获得批准。 国内上市原研药参比制剂罗库溴铵注射液（中文商品名为爱 ...

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 Meitheal Pharmaceuticals, Inc.（以下简称"Meitheal"）于近日收到美国食品药品 监督管理局（以下简称"美国 FDA"）签发的重酒石酸去甲肾上腺素注射液， 4mg/4mL（ANDA 号：040455）生产场地转移批准信，批准在公司子公司健进制 药有限公司场地生产。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 2025 年 2 月 27 日收到美国 FDA 的通知，公司子公司 Meitheal 向美 国 FDA 申报的重酒石酸去甲肾上腺素注射液，4 mg/4 mL（ANDA 号：040455） 生产场地转移至健进制药的申请已获得批准。 | 证券代码：603707 | 证券简称：健友股份 | 公告编号：2025-006 | | --- | --- | --- | | 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 子公司关于获得美国 FDA 重酒石酸去甲肾 上腺素注射液药品生产场地转移注册批件的公告 本公司董事会及全体董事保证本公告内容不存在任何 ...

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 ...