| 证券代码：603707 | 证券简称：健友股份 | 公告编号：2025-012 | | --- | --- | --- | | 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 关于子公司产品腺苷注射液获得美国 FDA 增加生产场地注册批件的公告 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"）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"）签发的腺苷注射液，3 mg/mL (60 mg/20 mL、90 mg/30 mL),（ANDA 号：077425）增加生产场地的批准信，批准在南京 健友生化制药股份有限公司场地生产。现将相关情况公告如下： 一、药品的基本情况 （一）药品名称：腺苷注射液 （二）适 应 症：对于不能充分运动的患者，腺苷注射液可作为铊-201 心肌 灌注显像的辅助手段。 二、药品其他相关情况 ...

证券研究报告 健友股份 (603707 CH) 类似药拾级而上，利拉获批再下一城 | 华泰研究 | | | 公告点评 | | --- | --- | --- | --- | | 2025 年 | 4 月 | 04 日│中国内地 | 化学制药 | 公司于 4 月 3 日公告其利拉鲁肽生物类似药在美获批。此为公司在美第二个 生物类似药批件，我们看好公司生物类似药业务起步，小分子制剂出口维持 较高增速，同时原料药、国内制剂等不确定性趋于出清。新一轮美国加征关 税不涉及药物，我们预计本轮关税对公司业务影响有限。维持"买入"评级。 利拉鲁肽：老牌大单品，类似药竞争格局尚较为健康 利拉鲁肽为一种 GLP-1 类似物，原研为诺和诺德的 Victoza，自 2010 年 以来陆续在美获批降糖/心血管/儿科降糖等多个适应症，在美销售峰值曾达 近 28 亿美元。目前除 Hikma/翰宇药业、健友股份的生物类似药分别于 12M24、4M25 获批外，暂无其他公司获批，竞争格局较为稳定。 制剂：稳增长延续，非肝素制剂出口持续发力 | 投资评级(维持): | 买入 | | --- | --- | | 目标价(人民币): | 22.10 ...

生物类似药：阿达木开始放量，利拉、白紫等陆续进入兑现期健友内外兼修构建生物类似药产品矩阵， 有望打造下一阶段增长引擎：1）7M24 购入阿达木单抗生物类似药批件，目前已启动销售；2）除利拉 鲁肽外，白蛋白紫杉醇亦有望于1H25 获批，竞争格局均较为健康；胰岛素产品有望自2026 年起陆续获 批；公司有望继续引进其他潜力品种，生物类似药产品矩阵逐渐成型。我们预计生物类似药业务将进一 步提高公司成长曲线。 盈利预测与估值 我们预测公司2024-2026 年归母净利润为9.71/11.36/14.43 亿元（分别下调2/8/11%，2025-26 年调整主要 反映地缘政治及潜在关税等外部环境影响），2025/26 年+17/27%yoy，对应2024-2026 年EPS 为 0.60/0.70/0.89元。我们给予公司2025 年PE 31.43x（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），对应合理估值357.04 亿元，目标价为22.10元（前值20.34 元，基于2025 年PE 26.70x， 较可比公司溢价20%）。 风险提示：政策不确定性风险，新产品获批及销售不及预期，汇兑风险。 公司 ...

获得美国 FDA 药品注册批件的公告 | 证券代码：603707 | 证券简称：健友股份 | 公告编号：2025-011 | | --- | --- | --- | | 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 关于产品利拉鲁肽注射液 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"）签发的利拉鲁肽注射液，18 mg/3 mL (6 mg/mL),（ANDA 号：218115）批准信，现将相关情况公告如下： 一、药品的基本情况 （一）药品名称：利拉鲁肽注射液 （二）适 应 症： 作为饮食和运动的辅助手段，改善成人和 10 岁及以上的儿童 2 型糖尿病患 者的血糖控制。 降低伴有心血管疾病的 2 型糖尿病成人患者的主要心血管不良事件的风险。 二、药品其他相关情况 公司于 2025 年 04 月 03 日获得美国 FDA 的通知，公司向美国 FDA 申报的 利拉 ...

| 证券代码：603707 | 证券简称：健友股份 | 公告编号：2025-010 | | --- | --- | --- | | 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： 未转股可转债情况： 截至 2025 年 3 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 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 张可转换公司债券 （以下简称"可转债"或"健友转债"），每张面值人民币 100 元，发行总额人 民币 5.0319 亿元，期限 6 年。经上海证券交易所自律监管决定书[2020]134 ...

| 证券代码：603707 | 证券简称：健友股份 | 公告编号：2025-009 | | --- | --- | --- | | 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 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 支付了 500 万 美元进度款（详见公司在上交所官网披露的公告，公告编号：2025-008），公司 子公司又于 2025 年 3 月 19 日向 Xentria 支付 1,500 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 2,500 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 对肺结节病患者有治疗作用， ...

健友股份 20250320 由于 2023 年肝素原料药行业不景气，无论是销售额还是价格均有所下滑。健友 股份因此计提了 12.4 亿元存货跌价准备，导致 2023 年归母净利润为负。到 2024 年肝素钠行业温和复苏，公司原材料采购价明显降低，因此转回存货跌价 准备 1.6 至 2.4 亿元，提高了归母净利润。2024 年公司发布业绩预告显示归母 净利润约为 8.0 至 10.5 亿元，实现扭亏为盈。 摘要 Q&A 健友股份近年来的转型和业务发展情况如何？ 健友股份近年来成功从肝素原料药企业转型为高端制剂企业。公司制剂业务的 营收占比已超过七成，成为主营业务，并且覆盖国内外市场，尤其在海外市场 拥有成熟的自营团队和丰富的 ANDA 批件数。在包括美国等海外市场，公司有超 过 50 个产品正在运行，同时在超过二十多个国家推进注册和销售拓展工作。公 司还与国内优秀企业合作拓展海外市场，如与双城药业合作白蛋白紫杉醇、与 通化东宝合作多个胰岛素类似物，这些产品在美国及其他海外市场上市工作正 在推进中。 健友股份在国内外市场的发展情况如何？ 在国内，健友股份近几年受到集采影响，其主要制剂进入国采范围后，通过集 采实现 ...

Investment Rating - The report initiates coverage with a "Buy" rating for the company [5]. Core Views - The company is transitioning from heparin raw materials to high-end injectable formulations, with a significant increase in the proportion of its formulation business, which accounted for over 70% of revenue in 2023 [1][17]. - The company has established a strong presence in the U.S. market, with over 50 products running and a sales revenue of 1.63 billion yuan in 2023, marking it as one of the largest Chinese pharmaceutical companies in the U.S. high-end formulation market [2][19]. - The heparin raw material business is stabilizing after a period of decline, with a projected mild recovery in 2024, which is expected to positively impact net profit [3][19]. Company Overview - The company is one of the largest global suppliers of heparin raw materials and formulations, with over 80 formulation varieties operating in more than 60 countries [1][10]. - The company has a mature R&D, quality, registration, and sales team in the U.S., leading the domestic industry in ANDA approvals [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 [22]. - The company has been actively expanding its domestic market presence through successful bids in national procurement, although sales have faced pressure due to price reductions [24][40]. - The company is also expanding its global footprint, with overseas revenue exceeding 70% of total revenue in 2023, driven by a robust product pipeline and strategic market entry [19][41]. Heparin Raw Material Business - The heparin raw material business has shown a stable production trend, with a slight recovery expected in 2024, which will help mitigate previous losses from inventory write-downs [3][19]. - The company recorded a write-down of 1.24 billion yuan in 2023 due to declining heparin prices, impacting net profit [3][19]. Financial Forecast and Investment Recommendations - The company is expected to achieve revenues of 4.24 billion yuan, 5.57 billion yuan, and 7.19 billion yuan for 2024, 2025, and 2026, respectively, with corresponding net profits of 946 million yuan, 1.16 billion yuan, and 1.62 billion yuan [4][19]. - The report anticipates continued growth in the formulation business, which will drive overall performance improvements [4][19].

Investment Rating - The report initiates coverage with 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 its 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 for the company, projecting revenues of 4.24 billion yuan, 5.57 billion yuan, and 7.19 billion yuan for 2024, 2025, and 2026, respectively, with corresponding net profits of 946 million yuan, 1.16 billion yuan, and 1.62 billion yuan [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 marketed 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 expanding its domestic market presence through successful bids in national procurement, although sales have faced pressure due to price reductions [24][40]. Heparin Raw Materials - The heparin raw material business has shown a mild recovery, with stable production levels. However, the company faced a significant inventory impairment in 2023, leading to a net profit decrease of 1.05 billion yuan. A recovery in the global heparin market is expected in 2024, with potential reversals of inventory impairments [3][19]. Financial Forecast and Investment Recommendations - The report anticipates substantial growth in the company's overseas formulation business, which is expected to drive overall performance. The projected earnings per share (EPS) for 2024, 2025, and 2026 are 0.59 yuan, 0.72 yuan, and 1.00 yuan, respectively [4][19].

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].